Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Carolyn Mulroney

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 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.

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 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 Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, 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 accepting new patients
    San Diego California 92093 United States
  • City of Hope National Medical Center accepting new patients
    Duarte California 91010 United States

Lead Scientist at UCSD

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Calibr, a division of Scripps Research
ID
NCT04488354
Phase
Phase 1
Study Type
Interventional
Last Updated