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A Phase 1/2 Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04984356
Recruitment Status : Recruiting
First Posted : July 30, 2021
Last Update Posted : June 23, 2022
Sponsor:
Information provided by (Responsible Party):
Wugen, Inc.

Brief Summary:
The main purpose of this study is to evaluate the safety, recommended dose, and preliminary anti-tumor activity of WU-CART-007 in patients with relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (LBL).

Condition or disease Intervention/treatment Phase
T-cell Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Biological: WU-CART-007 Phase 1 Phase 2

Detailed Description:
This is a first-in-human, multicenter, Phase 1/2, single-agent study in patients with R/R T-ALL/T-LBL who have exhausted other treatment options. The study will consist of two phases, Phase 1 and Phase 2. During the Dose Escalation segment (Phase 1) up to 24 patients will be treated with 1 dose of WU-CART-007, in up to 4 dose levels until maximum tolerated dose (MTD) or maximum administered dose (MAD) is determined. The dose escalation segment will enroll successive cohorts of 3 to 6 patients using a standard 3 + 3 design. Once the recommended phase 2 dose (RP2D) is defined, the Phase 2 portion (Cohort Expansion) will enroll expansion cohorts.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description:

There are two parts to this study. Phase 1 will comprise of Dose Escalation, and Phase 2 Cohort Expansion.

Phase 1 will determine the safety and tolerability of a single dose of WU-CART-007 and define the RP2D.

The Cohort Expansion Phase, will further define the safety and evaluate the initial efficacy of WU-CART-007 at the dose established from the Phase 1 Dose Escalation segment.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Dose-Escalation and Dose-Expansion Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL)
Actual Study Start Date : January 14, 2022
Estimated Primary Completion Date : May 2026
Estimated Study Completion Date : August 2026


Arm Intervention/treatment
Experimental: WU-CART-007

A CD7-directed chimeric antigen receptor (CAR) T-cell product.

A single IV infusion of WU-CART-007 Cells on Day 1 after Lymphodepletion(LD) Therapy. Cyclophosphamide 500 mg/m2/day x 3 (days -5 to -3) Fludarabine 30 mg/m2/day x 3 (days -5 to -3)

Biological: WU-CART-007
A single IV infusion of WU-CART-007 Cells on Day 1




Primary Outcome Measures :
  1. Incidence of Adverse Events of WU-CART-007 as assessed by CTCAE v5 [ Time Frame: 24 months ]
    Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of consent until end of study visit

  2. Maximum Tolerated Dose (MTD) [ Time Frame: up to 28 days from first dose ]
    Maximum tolerated or administered dose of WU-CART-007

  3. Overall Response Rate (ORR) [ Time Frame: 24 months ]
    ORR is defined as proportion of patients that achieve complete remission (CR) + complete remission with incomplete hematologic recover ( CRi)

  4. Duration of Response [ Time Frame: 24 months ]
    Time of response to the time of disease relapse, progression or death due to any cause, whichever occurs first

  5. Progression Free Survival [ Time Frame: 24 months ]
    Time from study drug administration (Day 1) to disease progression


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 24 months ]
    Time from study drug administration (Day 1) to death on study

  2. Hematopoietic Stem Cell Transplant (HSCT) rate [ Time Frame: 24 months ]
    Rate of successful transition to HSCT through study treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion/Exclusion Criteria:

Specific inclusion criteria apply to each disease subtype. In general, all patients will have:

  • Evidence of relapsed or refractory T-ALL or T-LBL, as defined by World Health Organization (WHO) classification with bone marrow with ≥ 5% lymphoblasts by morphologic assessment or evidence of extramedullary disease at screening.
  • Relapsed or refractory disease defined as at least one of the following criteria:

    1. Primary refractory: failure to achieve CR after induction chemotherapy, per investigator.
    2. Early Relapse: relapsed disease within 12 months of initial diagnosis.
    3. Late Relapse (relapsed refractory disease): relapsed disease after 12 months of initial diagnosis AND failure of re-induction therapy after disease recurrence.
    4. Relapsed or refractory disease after allogeneic transplant, and meet the following criteria:

    i. There must be histological confirmation of relapse after HSCT of T-ALL or T-LBL.

ii. Undergone allogeneic HSCT > 90 days prior to enrollment from a match related or unrelated donor, cord blood donor, haplo-identical, or autologous stem cells.

iii. Off all immunosuppressive medications for a minimum of 2 weeks with the exception of physiologic doses of corticosteroids.

iv. No prior history of veno-occlusive disease (VOD), or active graft versus host disease (GvHD) (see exclusion criteria below for exceptions).

  • Adequate renal, hepatic, respiratory, and cardiovascular function, as defined in the body of the protocol.
  • Life expectancy >12 weeks
  • Age: Lower age limit of 12 years. Adolescent ages 12-17 will be eligible for enrollment beginning at Dose Level 3 of the Dose Escalation phase, after review of safety, efficacy and cellular PK data and after consultation with the appropriate regulatory agencies.
  • ECOG/Karnofsky performance status 0 or 1 at screening (Adults age >16) or Lansky Performance Status 60 and above (adolescents ≤ 16),
  • Ability to understand the nature of this study, comply with protocol requirements, and give written informed consent. For minors, legal guardian willingness to give written informed consent with patient assent, where appropriate.
  • Willing to participate in WUC-007-02 for long-term follow up.

Patients will be excluded from study entry if:

  • They have received previous treatment with any prior anti-CD7 therapy.
  • Have not recovered from the effects of previous therapy.
  • Wash-out period of at least 5 half-lives from the last dose of any investigational therapy prior to screening period.
  • Have active or latent hepatitis B or active hepatitis C, any uncontrolled infection, or untreated HIV positive.
  • Have any serious active infection at the time of treatment, or another serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
  • Have Grade 2 to 4 acute or extensive chronic GvHD requiring systemic immunosuppression (steroids). Grade 1 GvHD not requiring immunosuppression is acceptable and grade 2 skin GvHD if treated with topical therapy only is acceptable.
  • Have psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
  • Pregnant or nursing (lactating) women
  • Require prohibited medications or treatments, eg, steroids, or anti-neoplastic agents
  • Treated with anti-T cell monoclonal antibodies (except daratumumab)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04984356


Contacts
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Contact: Eileen McNulty 917-573-8538 emcnulty@wugen.com

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact    877-467-3411      
Principal Investigator: Ibrahim Aldoss, MD         
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Principal Investigator: Deepa Bhojwani, MD         
United States, Florida
Moffit Cancer Center Not yet recruiting
Tampa, Florida, United States, 33612
Principal Investigator: Rawan Faramand, MD         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Katie Stricker    314-273-4902    kstricker@wustl.edu   
Principal Investigator: Armin Ghobadi, MD         
United States, Nebraska
University of Nebraska Not yet recruiting
Omaha, Nebraska, United States, 68198
Principal Investigator: Krishna Gundabolu, MBBS         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Shannon Maude, MD         
United States, Wisconsin
University of Wisconsin Not yet recruiting
Madison, Wisconsin, United States, 53792
Principal Investigator: Ryan Mattison, MD         
Australia, Victoria
Peter MacCallum Cancer Centre Recruiting
Melbourne, Victoria, Australia
Contact       enquiry@petermac.org   
Sponsors and Collaborators
Wugen, Inc.
Investigators
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Study Director: Ken Jacobs, MD Wugen, Inc.
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Responsible Party: Wugen, Inc.
ClinicalTrials.gov Identifier: NCT04984356    
Other Study ID Numbers: WU-CART-007 1001
First Posted: July 30, 2021    Key Record Dates
Last Update Posted: June 23, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wugen, Inc.:
CAR-T therapy
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases