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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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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

Intervention / Treatment
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* Combination Product: CLBR001 and SWI019


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLBR001 treated patients<br>Patients who have been administered with CLBR001 | Combination Product: CLBR001 and SWI019<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Incidence and duration of new serious adverse events | To measure the incidence and duration of new serious adverse events | 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 | 15 years | 
| Incidence of new malignancies | The measure the incidence of new malignancies | 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response | To evaluate clinical efficacy by measuring the overall response by Response Evaluation Criteria In Lymphoma (RECIL) 2017 | 15 years | 
| Duration of response | To evaluate clinical efficacy by measuring the duration of response | 15 years | 
| Progression free survival | To evaluate clinical efficacy by measuring progression free survival | 15 years | 
| Proportion of patients undergoing stem cell transplant | To evaluate the proportion of patients undergoing stem cell transplant | 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 | 3, 6, 9,12 and 24 months | 
| Detectable replication competent lentivirus (RCL) | To measure detectable replication competent lentivirus (RCL) | 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 | 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 | 3, 6, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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)