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

Primary Purpose

Relapsed/Refractory B-cell Lymphomas, Diffuse Large B-Cell Lymphoma (DLBCL), Follicular Lymphoma (FL)

Status
Enrolling by invitation
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CLBR001 and SWI019
Sponsored by
Calibr, a division of Scripps Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed/Refractory B-cell Lymphomas focused on measuring 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)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • City of Hope National Medical Center
  • University of California at San Diego
  • University of Chicago
  • Masonic Cancer Center, University of Minnesota
  • Weill Cornell Medical College - New York Presbyterian Hospital
  • Wake Forest Baptist Health
  • Sarah Cannon Research Institute - Tennessee Oncology
  • Sarah Cannon Research Institute - Texas Transplant Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CLBR001 treated patients

Arm Description

Patients who have been administered with CLBR001

Outcomes

Primary Outcome Measures

Incidence and duration of new adverse events, late onset adverse events, and events of special interest
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
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
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
The measure the incidence of new malignancies

Secondary Outcome Measures

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

Full Information

First Posted
July 20, 2020
Last Updated
June 27, 2023
Sponsor
Calibr, a division of Scripps Research
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1. Study Identification

Unique Protocol Identification Number
NCT04488354
Brief Title
Long-term Follow-up Study for Patients Treated With CLBR001 CAR-T
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 21, 2021 (Actual)
Primary Completion Date
August 2036 (Anticipated)
Study Completion Date
August 2036 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Calibr, a division of Scripps Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CLBR001 treated patients
Arm Type
Experimental
Arm Description
Patients who have been administered with CLBR001
Intervention Type
Combination Product
Intervention Name(s)
CLBR001 and SWI019
Intervention Description
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 Measure Information:
Title
Incidence and duration of new adverse events, late onset adverse events, and events of special interest
Description
To measure the incidence and duration of new adverse events, late onset adverse events, and events of special interest
Time Frame
15 years
Title
Incidence and duration of new serious adverse events
Description
To measure the incidence and duration of new serious adverse events
Time Frame
15 years
Title
Incidence of patients with resolution of adverse events, serious adverse events, and duration that began in previous treatment protocols of CLBR001
Description
The measure the 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
Title
Incidence of new malignancies
Description
The measure the incidence of new malignancies
Time Frame
15 years
Secondary Outcome Measure Information:
Title
Overall response
Description
To evaluate clinical efficacy by measuring the overall response by Response Evaluation Criteria In Lymphoma (RECIL) 2017
Time Frame
15 years
Title
Duration of response
Description
To evaluate clinical efficacy by measuring the duration of response
Time Frame
15 years
Title
Progression free survival
Description
To evaluate clinical efficacy by measuring progression free survival
Time Frame
15 years
Title
Proportion of patients undergoing stem cell transplant
Description
To evaluate the proportion of patients undergoing stem cell transplant
Time Frame
15 years
Title
Number of CLBR001 CAR+ cells in blood, bone marrow and/or tissue specimens
Description
To measure the number of CLBR001 CAR+ cells in blood, bone marrow and/or tissue specimens
Time Frame
3, 6, 9,12 and 24 months
Title
Detectable replication competent lentivirus (RCL)
Description
To measure detectable replication competent lentivirus (RCL)
Time Frame
15 years
Title
Titer of anti-drug antibody (ADA) for CLBR001 and SWI019
Description
To evaluate immunogenicity by measuring the titer of ADA for CLBR001 and SWI019
Time Frame
3, 6, 12 months
Title
Duration of detection of ADA for CLBR001 and SWI019
Description
To evaluate immunogenicity by measuring the duration of detection of ADA for CLBR001 and SWI019
Time Frame
3, 6, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California at San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Masonic Cancer Center, University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Weill Cornell Medical College - New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Sarah Cannon Research Institute - Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Sarah Cannon Research Institute - Texas Transplant Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26759369
Citation
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.
Results Reference
background
PubMed Identifier
30373813
Citation
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.
Results Reference
background

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

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