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

Sponsor

Calibr, a division of Scripps Research (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04488354

Collaborator

(none)

Enrollment

Locations

Arm

186.3

Anticipated Duration (Months)

4.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

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 Waldenstrom Macroglobulinemia Lymphoplasmacytic Lymphoma Burkitt 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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Jan 21, 2021

Anticipated Primary Completion Date :

Aug 1, 2036

Anticipated Study Completion Date :

Aug 1, 2036

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence and duration of new adverse events, late onset adverse events, and events of special interest [15 years]
To measure the incidence and duration of new adverse events, late onset adverse events, and events of special interest
Incidence and duration of new serious adverse events [15 years]
To measure the incidence and duration of new serious adverse events
Incidence of patients with resolution of adverse events, serious adverse events, and duration that began in previous treatment protocols of CLBR001 [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
Incidence of new malignancies [15 years]
The measure the incidence of new malignancies

Secondary Outcome Measures

Overall response [15 years]
To evaluate clinical efficacy by measuring the overall response by Response Evaluation Criteria In Lymphoma (RECIL) 2017
Duration of response [15 years]
To evaluate clinical efficacy by measuring the duration of response
Progression free survival [15 years]
To evaluate clinical efficacy by measuring progression free survival
Proportion of patients undergoing stem cell transplant [15 years]
To evaluate the proportion of patients undergoing stem cell transplant
Number of CLBR001 CAR+ cells in blood, bone marrow and/or tissue specimens [3, 6, 9,12 and 24 months]
To measure the number of CLBR001 CAR+ cells in blood, bone marrow and/or tissue specimens
Detectable replication competent lentivirus (RCL) [15 years]
To measure detectable replication competent lentivirus (RCL)
Titer of anti-drug antibody (ADA) for CLBR001 and SWI019 [3, 6, 12 months]
To evaluate immunogenicity by measuring the titer of ADA for CLBR001 and SWI019
Duration of detection of ADA for CLBR001 and SWI019 [3, 6, 12 months]
To evaluate immunogenicity by measuring the duration of detection of ADA for CLBR001 and SWI019

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope National Medical Center	Duarte	California	United States	91010
2	University of California at San Diego	San Diego	California	United States	92093
3	University of Chicago	Chicago	Illinois	United States	60637
4	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota	United States	55455
5	Weill Cornell Medical College - New York Presbyterian Hospital	New York	New York	United States	10065
6	Wake Forest Baptist Health	Winston-Salem	North Carolina	United States	27157
7	Sarah Cannon Research Institute - Tennessee Oncology	Nashville	Tennessee	United States	37203
8	Sarah Cannon Research Institute - Texas Transplant Institute	San Antonio	Texas	United States	78229