Clinical trial NCT04488354: 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
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: 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)
Lead sponsor: Calibr, a division of Scripps Research
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Incidence and duration of new adverse events, late onset adverse events, and events of special interest
timeFrame: 15 years
measure: Incidence and duration of new serious adverse events
timeFrame: 15 years
measure: Incidence of patients with resolution of adverse events, serious adverse events, and duration that began in previous treatment protocols of CLBR001
timeFrame: 15 years
measure: Incidence of new malignancies
timeFrame: 15 years
Secondary outcomes:
measure: Overall response
timeFrame: 15 years
measure: Duration of response
timeFrame: 15 years
measure: Progression free survival
timeFrame: 15 years
measure: Proportion of patients undergoing stem cell transplant
timeFrame: 15 years
measure: Number of CLBR001 CAR+ cells in blood, bone marrow and/or tissue specimens
timeFrame: 3, 6, 9,12 and 24 months
measure: Detectable replication competent lentivirus (RCL)
timeFrame: 15 years
measure: Titer of anti-drug antibody (ADA) for CLBR001 and SWI019
timeFrame: 3, 6, 12 months
measure: Duration of detection of ADA for CLBR001 and SWI019
timeFrame: 3, 6, 12 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: San Diego
country: United States
facility: University of California at San Diego
state: California
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
city: New York
country: United States
facility: Weill Cornell Medical College - New York Presbyterian Hospital
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Nashville
country: United States
facility: Sarah Cannon Research Institute - Tennessee Oncology
state: Tennessee
city: San Antonio
country: United States
facility: Sarah Cannon Research Institute - Texas Transplant Institute
state: Texas
Study officials:
References:
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.
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.