Burkitt Lymphoma, Chronic Lymphocytic Leukemia (CLL), Diffuse Large B-Cell Lymphoma (DLBCL), Follicular Lymphoma (FL), 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
Conditions
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)
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.
Interventions
COMBINATION_PRODUCTCLBR001 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
Sponsors
Calibr, a division of Scripps Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed