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

Waldenstrom Macroglobulinemia Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04488354
• Other study ID #: CBR-sCAR19-3002
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: January 21, 2021
• Est. completion date: August 2036

Study information

• Verified date: March 2024
• Source: Calibr, a division of Scripps Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 36
• Est. completion date: August 2036
• Est. primary completion date: August 2036
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burkitt Lymphoma
• Chronic Lymphocytic Leukemia (CLL)
• Diffuse Large B-Cell Lymphoma (DLBCL)
• Follicular Lymphoma (FL)
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Follicular
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Mantle-Cell
• Lymphoplasmacytic Lymphoma
• Mantle Cell Lymphoma (MCL)
• Marginal Zone Lymphoma (MZL)
• Primary Mediastinal Large B Cell Lymphoma
• Relapsed/Refractory B-cell Lymphomas
• Small Lymphocytic Lymphoma (SLL)
• Transformed Follicular Lymphoma
• Waldenstrom Macroglobulinemia

Intervention

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

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois
United States	City of Hope National Medical Center	Duarte	California
United States	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota
United States	Sarah Cannon Research Institute - Tennessee Oncology	Nashville	Tennessee
United States	Weill Cornell Medical College - New York Presbyterian Hospital	New York	New York
United States	Sarah Cannon Research Institute - Texas Transplant Institute	San Antonio	Texas
United States	University of California at San Diego	San Diego	California
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Calibr, a division of Scripps Research

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	15 years
Primary	Incidence and duration of new serious adverse events	To measure the incidence and duration of new serious adverse events	15 years
Primary	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	15 years
Primary	Incidence of new malignancies	The measure the incidence of new malignancies	15 years
Secondary	Overall response	To evaluate clinical efficacy by measuring the overall response by Response Evaluation Criteria In Lymphoma (RECIL) 2017	15 years
Secondary	Duration of response	To evaluate clinical efficacy by measuring the duration of response	15 years
Secondary	Progression free survival	To evaluate clinical efficacy by measuring progression free survival	15 years
Secondary	Proportion of patients undergoing stem cell transplant	To evaluate the proportion of patients undergoing stem cell transplant	15 years
Secondary	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	3, 6, 9,12 and 24 months
Secondary	Detectable replication competent lentivirus (RCL)	To measure detectable replication competent lentivirus (RCL)	15 years
Secondary	Titer of anti-drug antibody (ADA) for CLBR001 and SWI019	To evaluate immunogenicity by measuring the titer of ADA for CLBR001 and SWI019	3, 6, 12 months
Secondary	Duration of detection of ADA for CLBR001 and SWI019	To evaluate immunogenicity by measuring the duration of detection of ADA for CLBR001 and SWI019	3, 6, 12 months