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Trial record 2 of 2 for:    NCT04450069

Long-term Follow-up Study for Patients Treated With CLBR001 CAR-T

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04488354
Recruitment Status : Enrolling by invitation
First Posted : July 28, 2020
Last Update Posted : December 2, 2021
Sponsor:
Information provided by (Responsible Party):
Calibr, a division of Scripps Research

Brief Summary:
This study is designed as a long-term follow-up study of participants who have receive genetically modified autologous CLBR001 CAR-T cells in all clinical trials including NCT04450069, A Phase 1, Open-label, Dose Escalating Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the Combination of CLBR001 and SWI019 in Patients With Relapsed/Refractory B-cell Malignancies.

Condition or disease Intervention/treatment Phase
Relapsed/Refractory B-cell Lymphomas Diffuse Large B-Cell Lymphoma (DLBCL) Follicular Lymphoma (FL) Chronic Lymphocytic Leukemia (CLL) Marginal Zone Lymphoma (MZL) Mantle Cell Lymphoma (MCL) Small Lymphocytic Lymphoma (SLL) Primary Mediastinal Large B Cell Lymphoma Transformed Follicular Lymphoma Combination Product: CLBR001 and SWI019 Phase 1

Detailed Description:
Patients will be enrolled following either the completion or early termination/discontinuation from Study NCT04450069 or any protocol in which patients were administered CLBR001. Patients will begin the long-term follow-up period regardless of whether they responded to treatment or progressed on treatment. Patients will be followed for up to 15 years post CLBR001 infusion and will continue to be monitored for safety, immunogenicity, and efficacy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Long-Term Safety of CLBR001, A Lentiviral Based Chimeric Antigen Receptor, In Patients With B-Cell Malignancies Previously Administered CLBR001
Actual Study Start Date : January 21, 2021
Estimated Primary Completion Date : August 2036
Estimated Study Completion Date : August 2036


Arm Intervention/treatment
Experimental: CLBR001 treated patients
Patients who have been administered with CLBR001
Combination Product: CLBR001 and SWI019
No study drug is administered in this study. Patients who have received CLBR001 autologous CAR-T cells will be evaluated in this trial for long-term safety and efficacy




Primary Outcome Measures :
  1. Incidence and duration of new adverse events, late onset adverse events, and events of special interest [ Time Frame: 15 years ]
    To measure the incidence and duration of new adverse events, late onset adverse events, and events of special interest

  2. Incidence and duration of new serious adverse events [ Time Frame: 15 years ]
    To measure the incidence and duration of new serious adverse events

  3. Incidence of patients with resolution of adverse events, serious adverse events, and duration that began in previous treatment protocols of CLBR001 [ Time Frame: 15 years ]
    The measure the incidence of patients with resolution of adverse events, serious adverse events, and duration that began in previous treatment protocols of CLBR001

  4. Incidence of new malignancies [ Time Frame: 15 years ]
    The measure the incidence of new malignancies


Secondary Outcome Measures :
  1. Overall response [ Time Frame: 15 years ]
    To evaluate clinical efficacy by measuring the overall response by Response Evaluation Criteria In Lymphoma (RECIL) 2017

  2. Duration of response [ Time Frame: 15 years ]
    To evaluate clinical efficacy by measuring the duration of response

  3. Progression free survival [ Time Frame: 15 years ]
    To evaluate clinical efficacy by measuring progression free survival

  4. Proportion of patients undergoing stem cell transplant [ Time Frame: 15 years ]
    To evaluate the proportion of patients undergoing stem cell transplant

  5. Number of CLBR001 CAR+ cells in blood, bone marrow and/or tissue specimens [ Time Frame: 3, 6, 9,12 and 24 months ]
    To measure the number of CLBR001 CAR+ cells in blood, bone marrow and/or tissue specimens

  6. Detectable replication competent lentivirus (RCL) [ Time Frame: 15 years ]
    To measure detectable replication competent lentivirus (RCL)

  7. Titer of anti-drug antibody (ADA) for CLBR001 and SWI019 [ Time Frame: 3, 6, 12 months ]
    To evaluate immunogenicity by measuring the titer of ADA for CLBR001 and SWI019

  8. Duration of detection of ADA for CLBR001 and SWI019 [ Time Frame: 3, 6, 12 months ]
    To evaluate immunogenicity by measuring the duration of detection of ADA for CLBR001 and SWI019



Information from the National Library of Medicine

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

Inclusion Criteria:

  • All patients who received at least one CLBR001 cell dose and have either discontinued early or completed the core treatment protocol or any protocol such as a managed access protocol as applicable.
  • Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

Exclusion Criteria:

  • There are no specific exclusion criteria for this study

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): NCT04488354


Locations
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United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
University of California at San Diego
San Diego, California, United States, 92093
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Minnesota
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New York
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, United States, 10065
United States, North Carolina
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
United States, Tennessee
Sarah Cannon Research Institute - Tennessee Oncology
Nashville, Tennessee, United States, 37203
United States, Texas
Sarah Cannon Research Institute - Texas Transplant Institute
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Calibr, a division of Scripps Research
Investigators
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Principal Investigator: Carolyn Mulroney, M.D. University of California, San Diego
Publications:
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Responsible Party: Calibr, a division of Scripps Research
ClinicalTrials.gov Identifier: NCT04488354    
Other Study ID Numbers: CBR-sCAR19-3002
First Posted: July 28, 2020    Key Record Dates
Last Update Posted: December 2, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Calibr, a division of Scripps Research:
CAR-T Cell Therapy
Switchable CAR-T Cell
Autologous Cell Therapy
CD19 Positive Disease
Blood Cancer
Hematological malignancy
Neoplasms
CD19 CAR-T Cell
Long Term Follow Up (LTFU)
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia
Leukemia, B-Cell