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

NCT ID: NCT04488354

Last Updated: 2025-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-21

Study Completion Date

2036-08-31

Brief Summary

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This study is designed as a long-term follow-up study of participants who have receive genetically modified autologous CLBR001 CAR-T cells

Detailed Description

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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.

Conditions

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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 Waldenstrom Macroglobulinemia Lymphoplasmacytic Lymphoma Burkitt Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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CLBR001 treated patients

Patients who have been administered with CLBR001

Group Type EXPERIMENTAL

CLBR001 and SWI019

Intervention Type COMBINATION_PRODUCT

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

Interventions

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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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Calibr, a division of Scripps Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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City of Hope National Medical Center

Duarte, California, United States

Site Status

University of California at San Diego

San Diego, California, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Weill Cornell Medical College - New York Presbyterian Hospital

New York, New York, United States

Site Status

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Site Status

Sarah Cannon Research Institute - Tennessee Oncology

Nashville, Tennessee, United States

Site Status

Sarah Cannon Research Institute - Texas Transplant Institute

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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Rodgers DT, Mazagova M, Hampton EN, Cao Y, Ramadoss NS, Hardy IR, Schulman A, Du J, Wang F, Singer O, Ma J, Nunez V, Shen J, Woods AK, Wright TM, Schultz PG, Kim CH, Young TS. Switch-mediated activation and retargeting of CAR-T cells for B-cell malignancies. Proc Natl Acad Sci U S A. 2016 Jan 26;113(4):E459-68. doi: 10.1073/pnas.1524155113. Epub 2016 Jan 12.

Reference Type BACKGROUND
PMID: 26759369 (View on PubMed)

Viaud S, Ma JSY, Hardy IR, Hampton EN, Benish B, Sherwood L, Nunez V, Ackerman CJ, Khialeeva E, Weglarz M, Lee SC, Woods AK, Young TS. Switchable control over in vivo CAR T expansion, B cell depletion, and induction of memory. Proc Natl Acad Sci U S A. 2018 Nov 13;115(46):E10898-E10906. doi: 10.1073/pnas.1810060115. Epub 2018 Oct 29.

Reference Type BACKGROUND
PMID: 30373813 (View on PubMed)

Other Identifiers

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CBR-sCAR19-3002

Identifier Type: -

Identifier Source: org_study_id

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