Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

• ClinicalTrials.gov Identifier: NCT03331198
• Recruitment Status: Active, not recruiting
• First Posted: November 6, 2017
• Last Update Posted: March 31, 2023
• Sponsor: Juno Therapeutics, a Subsidiary of Celgene
• Information provided by (Responsible Party): Juno Therapeutics, a Subsidiary of Celgene

Study Description

Brief Summary:

This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with relapsed or refractory CLL or SLL, followed by a Phase 2 part to further assess the efficacy and safety of JCAR017 monotherapy treatment at the recommended dose. A separate Phase 1 cohort will assess the combination of JCAR017 and concurrent ibrutinib. Another separate Phase 1 cohort will assess the combination of JCAR017 and concurrent venetoclax. In all subjects, the safety, efficacy, and pharmacokinetics (PK) of JCAR017 will be evaluated.

Condition or disease	Intervention/treatment	Phase
Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Small Lymphocytic	Biological: JCAR017 (lisocabtagene maraleucel); Biological: JCAR017 (lisocabtagene maraleucel) + ibrutinib; Biological: JCAR017 (lisocabtagene maraleucel) + venetoclax	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 209 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Phase 1: subjects will be assigned to receive JCAR017, or JCAR017 + ibrutinib Phase 2: subjects will be assigned to receive JCAR017 at the recommended dose
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label, Phase 1/2 Study of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (017004)
• Actual Study Start Date: November 27, 2017
• Estimated Primary Completion Date: July 7, 2027
• Estimated Study Completion Date: July 7, 2027

Arms and Interventions

Arm	Intervention/treatment
Experimental: Phase 1 JCAR017 monotherapy; Subjects will be assigned to receive JCAR017 (lisocabtagene maraleucel)	Biological: JCAR017 (lisocabtagene maraleucel); Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive bridging anticancer therapy for disease control. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.
Experimental: Phase 1 JCAR017 + ibrutinib; Subjects receiving ibrutinib at baseline will be assigned to receive JCAR017 (lisocabtagene maraleucel) at the recommended dose from the Phase 1 monotherapy arm + ibrutinib	Biological: JCAR017 (lisocabtagene maraleucel) + ibrutinib; Participants eligible for this cohort should be receiving ibrutinib at the time of screening. For participants who previously discontinued ibrutinib, ibrutinib will be started as soon as possible after eligibility is confirmed. Ibrutinib treatment will continue for up to 90 days after JCAR017 infusion (or longer for participants who are receiving benefit from ibrutinib). Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive bridging chemotherapy for disease control. Upon successful generation of JCAR017 product, participants will receive treatment with JCAR017 therapy. Each cycle will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.
Experimental: Phase 2 JCAR017 monotherapy; Subjects will receive JCAR017 (lisocabtagene maraleucel) at the recommended dose from the Phase 1 monotherapy arm	Biological: JCAR017 (lisocabtagene maraleucel); Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive bridging anticancer therapy for disease control. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.
Experimental: Phase 1 JCAR017 + venetoclax; Subjects will receive venetoclax as bridging anticancer therapy until lymphodepletion chemotherapy/ JCAR017 (lisocabtagene maraleucel) at the recommended dose from the Phase 1 monotherapy arm. After JCAR017 infusion subjects will receive venetoclax until Day 90.	Biological: JCAR017 (lisocabtagene maraleucel) + venetoclax; Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants will receive venetoclax as bridging anticancer therapy on a weekly ramp up dosing schedule until stopping one day prior to lymphodepletion. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection, and the day after infusion venetoclax will be re-initiated.

Outcome Measures

Primary Outcome Measures :

1. Phase 1 JCAR017 monotherapy arm: adverse events [ Time Frame: Up to 48 months post treatment ]
   Proportion of subjects experiencing adverse events
2. Phase 1 JCAR017 monotherapy arm: laboratory abnormalities [ Time Frame: Up to 48 months post treatment ]
   Proportion of subjects experiencing laboratory abnormalities
3. Phase 1 JCAR017 and ibrutinib combination dose escalation therapy arm: adverse events [ Time Frame: Up to 48 months post treatment ]
   Proportion of subjects experiencing adverse events
4. Phase 1 JCAR017 and ibrutinib combination dose escalation therapy arm: laboratory abnormalities [ Time Frame: Up to 48 months post treatment ]
   Proportion of subjects experiencing laboratory abnormalities
5. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm [ Time Frame: Through post treatment up to Month 48 ]
   Proportion of subjects who have CR after treatment with JCAR017 + ibrutinib using iwCLL 2018 guidelines
6. Phase 1 JCAR017 and venetoclax combination dose escalation therapy arm: adverse events [ Time Frame: Up to 48 months post treatment ]
   Proportion of subjects experiencing adverse events
7. Phase 1 JCAR017 and venetoclax combination dose escalation therapy arm: laboratory abnormalities [ Time Frame: Up to 48 months post treatment ]
   Proportion of subjects experiencing laboratory abnormalities
8. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm [ Time Frame: Through post treatment up to Month 48 ]
   Proportion of subjects who have CR after treatment with JCAR017 + venetoclax using iwCLL 2018 guidelines
9. Phase 2 JCAR017 monotherapy expansion arm [ Time Frame: Through post treatment up to Month 48 ]
   Proportion of subjects who have CR after treatment with JCAR017 using iwCLL 2018 guidelines

Secondary Outcome Measures :

1. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: adverse events [ Time Frame: Up to 48 months post treatment ]
   Proportion of subjects experiencing adverse events
2. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: laboratory abnormalities [ Time Frame: Up to 48 months post treatment ]
   Proportion of subjects experiencing laboratory abnormalities
3. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: ORR [ Time Frame: Up to 48 months post treatment ]
   Defined as the rate of CR (including CRi)
4. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: MRD negative response rate in peripheral blood [ Time Frame: Up to 48 months post treatment ]
   Proportion of subjects who achieve MRD CR
5. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: MRD-negative CR rate in peripheral blood [ Time Frame: Up to 48 months post treatment ]
   Proportion of subjects who achieve MRD CR
6. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Duration of response (DOR) [ Time Frame: Up to 48 months post treatment ]
   Defined as the time from first response (CR, CRi, nPR, or PR) to the earlier date of PD or death due to any cause
7. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Duration of complete response (DoCR) [ Time Frame: Up to 48 months post treatment ]
   Defined as the time from first CR or CRi to the earlier date of PD or death due to any cause
8. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Time to response (TTR) [ Time Frame: Up to 48 months post treatment ]
   Defined as the interval from JCAR017 infusion to the first documentation of CR, CRi, nPR, or PR
9. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Time to complete response (TTCR) [ Time Frame: Up to 48 months post treatment ]
   Defined as the interval from JCAR017 infusion to the first documentation of CR
10. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: PFS [ Time Frame: Up to 48 months post treatment ]
    Defined as the time from JCAR017 infusion to the earlier date of PD or death due to any cause
11. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: OS [ Time Frame: Up to 48 months post treatment ]
    Defined as the time from JCAR017 infusion to the date of death due to any cause
12. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: adverse events [ Time Frame: Up to 48 months post treatment ]
    Proportion of subject experiencing adverse events
13. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: lab abnormalities [ Time Frame: Up to 48 months post treatment ]
    Proportion of subjects experiencing laboratory abnormalities
14. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: ORR [ Time Frame: Through post treatment Day 90 ]
    Defined as the rate of CR (including CRi)
15. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: MRD-negative response rate in peripheral blood [ Time Frame: Up to 48 months post treatment ]
    Proportion of subjects who achieve MRD CR
16. Phase 1 JCAR017 and venetoclax combination dose escalation therapy arm: MRD-negative CR rate in peripheral blood [ Time Frame: Through post treatment Day 90 ]
    Proportion of subjects who achieve MRD CR
17. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: Duration of response (DOR) [ Time Frame: Up to 48 months post treatment ]
    Defined as the time from first response (CR, CRi, nPR, or PR) to the earlier date of PD or death due to any cause
18. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: Duration of complete response (DoCR) [ Time Frame: Up to 48 months post treatment ]
    Defined as the time from first CR or CRi to the earlier date of PD or death due to any cause
19. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: Time to response (TTR) [ Time Frame: Up to 48 months post treatment ]
    Defined as the interval from JCAR017 infusion to the first documentation of CR, CRi, nPR, or PR
20. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: Time to complete response (TTCR) [ Time Frame: Up to 48 months post treatment ]
    Defined as the interval from JCAR017 infusion to the first documentation of CR
21. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: PFS [ Time Frame: Up to 48 months post treatment ]
    Defined as the time from JCAR017 infusion to the earlier date of PD or death due to any cause
22. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: OS [ Time Frame: Up to 48 months post treatment ]
    Defined as the time from JCAR017 infusion to the date of death due to any cause
23. Phase 2 JCAR017 Monotherapy Expansion Arm: adverse events [ Time Frame: Up to 48 months post treatment ]
    Proportion of subjects experiencing adverse events
24. Phase 2 JCAR017 Monotherapy Expansion Arm: laboratory abnormalities [ Time Frame: Up to 48 months post treatment ]
    Proportion of subjects experiencing laboratory abnormalities
25. Phase 2 JCAR017 Monotherapy Expansion Arm: ORR [ Time Frame: Up to 48 months post treatment ]
    Defined as the rate of CR (including CRi)
26. Phase 2 JCAR017 Monotherapy Expansion Arm: MRD negative response rate in peripheral blood [ Time Frame: Up to 48 months post treatment ]
    Proportion of subjects who achieve MRD CR
27. Phase 2 JCAR017 Monotherapy Expansion Arm: MRD-negative CR rate in peripheral blood [ Time Frame: Up to 48 months post treatment ]
    Proportion of subjects who achieve MRD CR
28. Phase 2 JCAR017 Monotherapy Expansion Arm: Duration of response (DOR) [ Time Frame: Up to 48 months post treatment ]
    Defined as the time from first response (CR, CRi, nPR, or PR) to the earlier date of PD or death due to any cause
29. Phase 2 JCAR017 Monotherapy Expansion Arm: Duration of complete response (DoCR) [ Time Frame: Up to 48 months post treatment ]
    Defined as the time from first CR or CRi to the earlier date of PD or death due to any cause
30. Phase 2 JCAR017 Monotherapy Expansion Arm: Time to response (TTR) [ Time Frame: Up to 48 months post treatment ]
    Defined as the interval from JCAR017 infusion to the first documentation of CR, CRi, nPR, or PR
31. Phase 2 JCAR017 Monotherapy Expansion Arm: Time to complete response (TTCR) [ Time Frame: Up to 48 months post treatment ]
    Defined as the interval from JCAR017 infusion to the first documentation of CR
32. Phase 2 JCAR017 Monotherapy Expansion Arm: PFS [ Time Frame: Up to 48 months post treatment ]
    Defined as the time from JCAR017 infusion to the earlier date of PD or death due to any cause
33. Phase 2 JCAR017 Monotherapy Expansion Arm: OS [ Time Frame: Up to 48 months post treatment ]
    Defined as the time from JCAR017 infusion to the date of death due to any cause
34. Phase 2 JCAR017 Monotherapy Expansion Arm: Health-related quality of life (HRQoL) questionnaire [ Time Frame: Up to 48 months post treatment ]
    Change from baseline in HRQoL assessed using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
35. Phase 2 JCAR017 Monotherapy Expansion Arm: HRQoL questionnaire [ Time Frame: Up to 48 months post treatment ]
    Change from baseline in HRQoL assessed using the EORTC chronic lymphocytic leukemia (CLL)-specific module QLQ-CLL-17
36. Phase 2 JCAR017 Monotherapy Expansion Arm: Health economics and outcomes research (HEOR) questionnaire [ Time Frame: Up to 48 months post treatment ]
    Change from baseline in measurement of health utility values using EuroQol instrument EQ-5D-5L
37. Phase 2 JCAR017 Monotherapy Expansion Arm: HEOR questionnaire [ Time Frame: Up to 48 months post treatment ]
    Proportion of participants with intensive care unit (ICU) inpatient days
38. Phase 2 JCAR017 Monotherapy Expansion Arm: HEOR questionnaire [ Time Frame: Up to 48 months post treatment ]
    Proportion of participants with non-ICU inpatient days

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Diagnosis of:

  1. CLL with an indication for treatment based on the Investigator's opinion and measurable disease, or
  2. SLL (lymphadenopathy and/or splenomegaly and < 5×10^9 CD19+ CD5+ clonal B lymphocytes/L [< 5000/µL] in the peripheral blood at diagnosis with measurable disease that is biopsy-proven SLL)
• Subjects (other than those in the ibrutinib + JCAR017 combination therapy cohort) must have received and failed Bruton tyrosine kinase inhibitor (BTKi) treatment or have been deemed ineligible for BTKi therapy.

• Subjects (other than those in the ibrutinib + JCAR017 combination therapy cohort) must have received previous treatment as follows:

  1. Subjects with CLL or SLL and high-risk features must have failed at least 2 lines of prior therapy.
  2. Subjects with CLL or SLL and standard-risk features must have failed at least 3 lines of prior therapy.

• Subjects in the ibrutinib + JCAR017 combination therapy cohort must either:

  1. be receiving ibrutinib and progressing at the time of study enrollment
  2. be receiving ibrutinib for at least 6 months with a response less than complete response/remission (CR) and have high-risk features as defined in inclusion criterion 5a
  3. have BTK or PLCgamma2 mutations per local laboratory assessment, with or without progression on ibrutinib
  4. have previously received ibrutinib and have no contraindications to restarting ibrutinib
• Eastern Cooperative Oncology Group performance status of ≤ 1
• Assessed by the Investigator to have adequate bone marrow function to receive lymphodepleting chemotherapy

• Adequate organ function, defined as:

  1. Serum creatinine ≤ 1.5 × age-adjusted upper limit of normal (ULN) OR calculated creatinine clearance > 30 mL/min
  2. Alanine aminotransferase ≤ 5 × ULN and total bilirubin < 2.0 mg/dL (or < 3.0 mg/dL for subjects with Gilbert's syndrome or leukemic infiltration of the liver)
  3. Adequate pulmonary function, defined as ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 dyspnea and saturated oxygen (SaO2) ≥ 92% on room air
  4. Adequate cardiac function, defined as left ventricular ejection fraction ≥ 40% as assessed by echocardiogram or multiple uptake gated acquisition scan performed within 30 days prior to determination of eligibility
• Subject either currently has central vascular access or is a candidate to receive central vascular access or peripheral vascular access for leukapheresis procedure.
• If prior CD19-targeted therapy has been administered, subject must have CD19-positive disease confirmed by immunohistochemistry or flow cytometry since completing the prior CD19-targeted therapy.
• Subjects in ibrutinib + JCAR017 combination cohort must have progressed on a BTKi and have received prior therapy with venetoclax

• Subjects in venetoclax + JCAR017 combination cohort must:

  1. have failed at least 1 prior line of therapy, including failed BTKi therapy or have been deemed ineligible to receive BTKi
  2. be venetoclax naive (required for dose expansion) or
  3. if prior venetoclax (only for dose escalation)
  4. have no contraindictions to re-initiation of venetoclax based on prior intolerance and have had at least 6 months elapsed since the last dose of venetoclax, if either, best response was stable disease, or subject experienced disease progression on venetoclax, or within 6 months of venetoclax discontinuation
• subjects in the venetoclax + JCAR017 combination must have hemoglobin >=9 g/dL, absolute neutrophil count >=500mm3 and platelets>= 75,000/mm3, unless cytopenias are judged by investigator to be due to CLL infiltration of the bone marrow
• must have diagnosis of CLL or SLL with an indication for treatment based on the investigator's opinion and measurable disease (any of the following measurable lymph nodes ≥1.5 cm in the greatest transverse diameter and/or hepatomegaly or splenomegaly) and demonstration of CLL cells in the peripheral blood by flow cytometry

Exclusion Criteria:

• Subjects with known active central nervous system (CNS) involvement by malignancy. Those with prior CNS disease that has been effectively treated will be eligible if treatment was completed at least 3 months prior to enrollment with no evidence of symptomatic disease and stable abnormalities on repeat imaging.
• History of another primary malignancy that has not been in remission for at least 2 years. (The following are exempt from the 2-year limit: nonmelanoma skin cancer, completely resected stage 1 solid tumor with low risk for recurrence, curatively treated localized prostate cancer, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear, and in situ breast cancer that has been completely resected.)
• Subjects with Richter's transformation
• Prior treatment with any gene therapy product
• Active hepatitis B, active hepatitis C, or active human immunodeficiency virus (HIV) infection
• Systemic fungal, bacterial, viral, or other infection that is not controlled
• Presence of acute or extensive chronic graft versus host disease (GVHD)
• History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease
• History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, aphasia, stroke with current neurologic sequelae, severe brain injuries, dementia, Parkinson's disease, cerebellar disease,cerebral edema, or psychosis
• Pregnant or nursing (lactating) women

• Use of any of the following medications or treatments within the noted time prior to leukapheresis:

  1. Alemtuzumab within 6 months prior to leukapheresis
  2. Allogeneic hematopoietic stem cell transplant within 100 days prior to leukapheresis
  3. Cladribine within 3 months prior to leukapheresis
  4. Donor lymphocyte infusions (DLI) within 2 months prior to leukapheresis
  5. Radiation including large bone marrow fields such as sternum or pelvis within 6 weeks prior to leukapheresis
  6. Fludarabine within 4 weeks prior to leukapheresis
  7. GVHD therapies such as calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolate mofetil, rapamycin, or immunosuppressive antibodies (such as anti-tumor necrosis factor-α [TNFα], anti-interleukin-6 [IL-6], or anti-interleukin-6 receptor [IL 6R]) within 4 weeks prior to leukapheresis
  8. Cyclophosphamide, ifosfamide, bendamustine, chlorambucil, or melphalan within 2 weeks prior to leukapheresis
  9. Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) within 7 days prior to leukapheresis
  10. Anti-CD20 monoclonal antibodies within 7 days prior to leukapheresis
  11. Venetoclax within 4 days prior to leukapheresis
  12. Idelalisib or duvelisib within 2 days prior to leukapheresis
  13. Lenalidomide within 1 day prior to leukapheresis
  14. Experimental agents, including off-label use of approved drugs (with the exception of acalabrutinib which may be continued up to the day before leukapheresis), within 4 weeks prior to leukapheresis unless progression is documented on the experimental therapy and at least 3 half-lives have elapsed prior to leukapheresis
• Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the Investigator; or subject unwillingness or inability to follow the procedures required in the protocol
• Progressive vascular tumor invasion, thrombosis, or embolism
• Deep vein thrombosis or embolism not managed on a stable regimen of anticoagulation
• Use of any of the following medications or treatments within the noted time prior to leukapheresis lenalidomide or acalabrutinib within 1 day prior to leukapheresis experimental agents, including off-label use of approved drugs, within 4 weeks prior to leukapheresis.
• Venous thrombosis or embolism requiring treatment but not managed on a stable regimen of anticoagulation
• For subjects in the venetoclax + JCAR017 combination cohorts only, concomitant treatment with CYP3A moderate/strong inducers or moderate/strong inhibitors which cannot be discontinued

Contacts and Locations

Locations

United States, Alabama

Local Institution - 0006

Birmingham, Alabama, United States, 35294

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

United States, Arizona

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States, 85234

Local Institution - 0043

Gilbert, Arizona, United States, 85234

United States, California

Local Institution - 0007

Duarte, California, United States, 91010-301

City of Hope

Duarte, California, United States, 91010

Local Institution - 0025

La Jolla, California, United States, 92093

UC San Diego Moores Cancer Center

La Jolla, California, United States, 92093

Local Institution - 0059

Los Angeles, California, United States, 90095

University of California, Los Angeles

Los Angeles, California, United States, 90095

Local Institution - 0010

San Francisco, California, United States, 94142

University of California, San Francisco

San Francisco, California, United States, 94143

United States, District of Columbia

Georgetown University Medical Center

Washington, District of Columbia, United States, 20007

Local Institution - 0085

Washington, District of Columbia, United States, 20007

United States, Florida

Local Institution - 0080

Jacksonville, Florida, United States, 32224

Mayo Clinic

Jacksonville, Florida, United States, 32224

United States, Georgia

Local Institution - 0019

Atlanta, Georgia, United States, 30342

The Blood and Marrow Transplant Group of Georgia (BMTGA)

Atlanta, Georgia, United States, 30342

United States, Illinois

Local Institution - 0003

Chicago, Illinois, United States, 60611

Northwestern University

Chicago, Illinois, United States, 60611

Local Institution - 0016

Chicago, Illinois, United States, 60637

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

United States, Massachusetts

Local Institution - 0005

Boston, Massachusetts, United States, 02114

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Local Institution - 0015

Boston, Massachusetts, United States, 02215

United States, Michigan

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States, 48109-5362

Local Institution - 0084

Ann Arbor, Michigan, United States, 48109

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Local Institution - 0062

Detroit, Michigan, United States, 48201

United States, Minnesota

Local Institution - 0054

Rochester, Minnesota, United States, 55905

Mayo Clinic

Rochester, Minnesota, United States, 55905

United States, Nebraska

Local Institution - 0008

Omaha, Nebraska, United States, 68198

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

United States, New Jersey

Local Institution - 0038

Hackensack, New Jersey, United States, 07601-2191

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

Local Institution - 0077

New Brunswick, New Jersey, United States, 08903

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States, 08903

United States, New York

Local Institution - 0035

New York, New York, United States, 10021

Local Institution - 0026

New York, New York, United States, 10032

Weill Cornell Medical College

New York, New York, United States, 10065

United States, North Carolina

Local Institution - 0030

Durham, North Carolina, United States, 27705

Duke University Medical Center

Durham, North Carolina, United States, 27710

United States, Ohio

University Hospitals Seidman Cancer Center (Case Western)

Cleveland, Ohio, United States, 44106-5061

Local Institution - 0078

Cleveland, Ohio, United States, 44106

United States, Oklahoma

Local Institution - 0082

Oklahoma City, Oklahoma, United States, 73104

University of Oklahoma Health Sciences Center (Stephenson Cancer Center)

Oklahoma City, Oklahoma, United States, 73104

United States, Oregon

Local Institution - 0098

Eugene, Oregon, United States, 97401

United States, Pennsylvania

Local Institution - 0088

Philadelphia, Pennsylvania, United States, 19104

University of Pennsylvania Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States, 19104

Local Institution - 0032

Philadelphia, Pennsylvania, United States, 19107

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Local Institution - 0029

Pittsburgh, Pennsylvania, United States, 15232

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232

United States, Texas

Baylor University Medical Center

Dallas, Texas, United States, 75246

Local Institution - 0083

Dallas, Texas, United States, 75390

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Local Institution - 0079

Dallas, Texas, United States, 75426

Local Institution - 0002

Houston, Texas, United States, 77030

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

United States, Utah

Huntsman Cancer Institute

Salt Lake City, Utah, United States, 84112

Local Institution - 0028

Salt Lake City, Utah, United States, 84112

United States, Virginia

Local Institution - 0087

Richmond, Virginia, United States, 23298

United States, Washington

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States, 98109

Local Institution - 0018

Seattle, Washington, United States, 98109

United States, Wisconsin

Local Institution - 0055

Milwaukee, Wisconsin, United States, 53226-3522

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

Juno Therapeutics, a Subsidiary of Celgene

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trial Information 

BMS Clinical Trial Patient Recruiting 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Teoh J, Brown LF. Developing lisocabtagene maraleucel chimeric antigen receptor T-cell manufacturing for improved process, product quality and consistency across CD19+ hematologic indications. Cytotherapy. 2022 Sep;24(9):962-973. doi: 10.1016/j.jcyt.2022.03.013. Epub 2022 May 21.

Siddiqi T, Soumerai JD, Dorritie KA, Stephens DM, Riedell PA, Arnason J, Kipps TJ, Gillenwater HH, Gong L, Yang L, Ogasawara K, Thorpe J, Wierda WG. Phase 1 TRANSCEND CLL 004 study of lisocabtagene maraleucel in patients with relapsed/refractory CLL or SLL. Blood. 2022 Mar 24;139(12):1794-1806. doi: 10.1182/blood.2021011895.

• Responsible Party: Juno Therapeutics, a Subsidiary of Celgene
• ClinicalTrials.gov Identifier: NCT03331198
• Other Study ID Numbers: 017004; TRANSCEND-CLL-004 ( Other Identifier: Juno Therapeutics, Inc. )
• First Posted: November 6, 2017
• Last Update Posted: March 31, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Juno Therapeutics, a Subsidiary of Celgene:

TRANSCEND_CLL_004

Additional relevant MeSH terms:

Lymphoma; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Chronic Disease; Disease Attributes; Pathologic Processes; Venetoclax; Antineoplastic Agents