Long-term Follow-up Study for Patients Treated With CLBR001 CAR-T
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.
|Condition or Disease||Intervention/Treatment||Phase|
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.
Arms and Interventions
|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
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
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
- There are no specific exclusion criteria for this study
Contacts and Locations
|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|
Sponsors and Collaborators
- Calibr, a division of Scripps Research
- Principal Investigator: Carolyn Mulroney, M.D., University of California, San Diego
Study Documents (Full-Text)None provided.
- 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.
- 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.