Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
estimated completion

Description

Summary

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

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

Details

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.

Keywords

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, 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), Lymphoma, Lymphoma, Follicular, Lymphoma, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse, CLBR001 and SWI019

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • There are no specific exclusion criteria for this study

Locations

  • University of California at San Diego
    San Diego California 92093 United States
  • City of Hope National Medical Center
    Duarte California 91010 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Calibr, a division of Scripps Research
ID
NCT04488354
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 36 study participants
Last Updated