CB-Long-Term Safety Study (CB-LTSS)

Study Overview
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Brief Summary
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This is a non-interventional, long-term safety study of allogeneic CAR-T cell therapy in patients with hematologic malignancies. Its purpose of is to collect long-term observational data to identify and understand potential late side effects in patients who have received CAR-T cell therapies.

Detailed Description
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This is a non-interventional, long-term safety study of allogeneic CAR-T cell therapy in patients with hematologic malignancies. The purpose of this 15-year research study is to collect long-term observational data to identify and understand potential late side effects in patients who have received CAR-T cell therapies as part of a previous Caribou-sponsored study or a Caribou-sponsored special access program.

Official Title
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A Study to Evaluate Long-Term Safety of CAR-T Cell Therapy in Patients With Hematologic Malignancies

Conditions
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Lymphoma, Lymphoma, Non-Hodgkin, Relapsed Non-Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Non-Hodgkin Lymphoma, B Cell Lymphoma, B-Cell Non-Hodgkin's Lymphoma, Hematologic Malignancy

Intervention / Treatment
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* Biological: Allogeneic CAR-T therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent obtained prior to study-specific activities/enrollment Received an allogeneic CAR-T therapy and completed or discontinued from a Caribou-sponsored study evaluating an allogeneic CAR-T therapy or was administered an allogeneic CAR-T therapy under a special access mechanism Exclusion Criteria: None

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients who received a Caribou-sponsored allogeneic CAR-T therapy<br>in a Caribou-sponsored clinical study or special access program | Biological: Allogeneic CAR-T therapy<br>* N/A this is an observational study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of targeted AEs | Incidence of targeted AEs post an allogeneic CAR-T therapy infusion from enrollment into CB-LTSS through Year 15 | 15 Years | 
| Frequency of targeted AEs | Frequency of targeted AEs post an allogeneic CAR-T therapy infusion from enrollment into CB-LTSS through Year 15 | 15 Years | 
| Duration of targeted AEs | Duration of targeted AEs post an allogeneic CAR-T therapy infusion from enrollment into CB-LTSS through Year 15 | 15 Years | 
| Outcome of targeted AEs | Outcome of targeted AEs post an allogeneic CAR-T therapy infusion from enrollment into CB-LTSS through Year 15 | 15 Years | 
| Incidence of serious AESIs | Incidence of serious AESIs related to an allogeneic CAR-T therapy infusion from enrollment into CB-LTSS through Year 15 | 15 Years | 
| Frequency of serious AESIs | Frequency of serious AESIs related to an allogeneic CAR-T therapy infusion from enrollment into CB-LTSS through Year 15 | 15 Years | 
| Duration of serious AESIs | Duration of serious AESIs related to an allogeneic CAR-T therapy infusion from enrollment into CB-LTSS through Year 15 | 15 Years | 
| Outcome of serious AESIs | Outcome of serious AESIs related to an allogeneic CAR-T therapy infusion from enrollment into CB-LTSS through Year 15 | 15 Years | 
| Incidence of SUSARs | Incidence of SUSARs which may indicate a new safety signal related to an allogeneic CAR-T therapy from enrollment into CB-LTSS through Year 15 | 15 Years | 
| Frequency of SUSARs | Frequency of SUSARs which may indicate a new safety signal related to an allogeneic CAR-T therapy from enrollment into CB-LTSS through Year 15 | 15 Years | 
| Duration of SUSARs | Duration of SUSARs which may indicate a new safety signal related to an allogeneic CAR-T therapy from enrollment into CB-LTSS through Year 15 | 15 Years | 
| Outcome of SUSARs | Outcome of SUSARs which may indicate a new safety signal related to an allogeneic CAR-T therapy from enrollment into CB-LTSS through Year 15 | 15 Years | 
| Incidence of AEs related to an allogeneic CAR-T therapy leading to death | Incidence of AEs related to an allogeneic CAR-T therapy leading to death from enrollment into CB-LTSS through Year 15 | 15 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Assessment of overall survival at 3 months and 6 months post an allogeneic CAR-T therapy infusion, then yearly through Year 15 | 15 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allogeneic CAR-T, CB-010