This study is designed as a long-term follow-up study of participants who have receive genetically modified autologous CLBR001 CAR-T cells
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
16
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
City of Hope National Medical Center
Duarte, California, United States
University of California at San Diego
San Diego, California, United States
University of Chicago
Chicago, Illinois, United States
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Sarah Cannon Research Institute - Tennessee Oncology
Nashville, Tennessee, United States
Sarah Cannon Research Institute - Texas Transplant Institute
San Antonio, Texas, United States
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
Time frame: 15 years
Incidence and duration of new serious adverse events
To measure the incidence and duration of new serious adverse events
Time frame: 15 years
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
Time frame: 15 years
Incidence of new malignancies
The measure the incidence of new malignancies
Time frame: 15 years
Overall response
To evaluate clinical efficacy by measuring the overall response by Response Evaluation Criteria In Lymphoma (RECIL) 2017
Time frame: 15 years
Duration of response
To evaluate clinical efficacy by measuring the duration of response
Time frame: 15 years
Progression free survival
To evaluate clinical efficacy by measuring progression free survival
Time frame: 15 years
Proportion of patients undergoing stem cell transplant
To evaluate the proportion of patients undergoing stem cell transplant
Time frame: 15 years
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
Time frame: 3, 6, 9,12 and 24 months
Detectable replication competent lentivirus (RCL)
To measure detectable replication competent lentivirus (RCL)
Time frame: 15 years
Titer of anti-drug antibody (ADA) for CLBR001 and SWI019
To evaluate immunogenicity by measuring the titer of ADA for CLBR001 and SWI019
Time frame: 3, 6, 12 months
Duration of detection of ADA for CLBR001 and SWI019
To evaluate immunogenicity by measuring the duration of detection of ADA for CLBR001 and SWI019
Time frame: 3, 6, 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.