Long-term Follow-up Study of Patients Receiving CAR-T Cells

Study Overview
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Brief Summary
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This protocol is designed as a long-term follow-up study of participants who will receive CAR-T cells as part of a clinical trial at the Medical College of Wisconsin/ Froedtert Hospital. The clinical trials include the following: Phase 1 Study of CAR-20/19-T Cells in Patients with Relapsed Refractory B Cell Malignancies (NCT03019055); Phase I Trial of BCMA-TGF-BETA CAR-T Cells in Relapsed, Refractory Myeloma (NCT05976555); CAR20.19.22 T-cells in Relapsed, Refractory B-cell Malignancies (NCT05094206); LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies (NCT05990465); CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies (NCT04186520)

Detailed Description
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The objective is to follow participants receiving CAR-T cells from years 2 to 15 post-treatment for persistence of CAR-T cells, development of secondary malignancies, or other medical complications.

Official Title
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Long-term Follow-up Study of Patients Receiving CAR-T Cells

Conditions
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Follicular Lymphoma, Chronic Lymphocytic Leukemia, Lymphomas Non-Hodgkin's B-Cell, Lymphoma, Small Lymphocytic, Mantle Cell Lymphoma, Central Nervous System Lymphoma, Diffuse Large B Cell Lymphoma, Burkitt Lymphoma, Multiple Myeloma

Intervention / Treatment
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* Other: Long-Term Follow-Up of Participants who Received CAR-T cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All participants who enrolled in a CAR-T study at Froedtert Hospital & the Medical College of Wisconsin. Exclusion Criteria: There are no exclusion criteria for this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Participants who received CAR-T cells.<br>Participants who received CAR-T cells at Froedtert Hospital & the Medical College of Wisconsin in clinical trials (e.g., NCT05976555, NCT05094206, NCT05990465, NCT03019055 or NCT04186520). | Other: Long-Term Follow-Up of Participants who Received CAR-T cells<br>* No study drug is administered in this study. Participants who received CAR-T cells in a previous trial 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 |
| --- | --- | --- |
| Change from baseline in the incidence of a new malignancy at 5 years. | The number of subjects with new malignancy. | Baseline to five years. | 
| Change from baseline in the incidence of a new malignancy at 10 years. | The number of subjects with new malignancy. | Baseline to 10 years. | 
| Change from baseline in the incidence of a new malignancy at 15 years. | The number of subjects with new malignancy. | Baseline to 15 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAR-T Cell Therapy, chimeric antigen receptor