Long-term Follow-up Study in Patients Previously Treated With a Mustang Bio CAR-T Cell Investigational Product.

Study Overview
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Brief Summary
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A long-term follow-up study to assess safety and efficacy in patients previously treated with Mustang Bio chimeric antigen receptor (CAR)-T cell investigational products.

Detailed Description
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Non-interventional, multi-center, long-term follow-up study of subjects previously treated with a Mustang Bio CAR-T cell investigational product in a Mustang Bio sponsored clinical study. Subjects who enroll will be monitored for a total of up to 15 years from the time of their last investigational product infusion.

Official Title
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A Long-term Follow-up Study in Patients Previously Treated With Mustang Bio, Inc. CAR-T Cell Investigational Products

Conditions
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Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), Chronic Lymphocytic Leukemia in Relapse, Small Lymphocytic Lymphoma, Relapsed, Waldenstrom's Macroglobulinemia Recurrent, Follicular B-cell Non-Hodgkin's Lymphoma, B-cell Lymphoma Refractory, Mantle Cell Lymphoma Recurrent, Hairy Cell Leukemia, Diffuse Large B Cell Lymphoma, Waldenstrom's Macroglobulinemia Refractory, Mantle Cell Lymphoma Refractory

Intervention / Treatment
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* Biological: Prior MB-102 CAR-T cell investigational product.
* Biological: Prior MB-106 CAR-T cell investigational product.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients previously treated with a Mustang Bio CAR-T cell investigational product in a prior Mustang Bio sponsored clinical study. Patient has provided signed and dated informed consent. Exclusion Criteria: None. All patients who have received prior treatment with Mustang Bio CAR-T cell investigational product in a Mustang Bio sponsored clinical study are eligible for this long-term follow up (LTFU) 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prior MB-102 CAR-T cell investigational product.<br>Patients previously treated with MB-102 CAR-T cell investigational product. | Biological: Prior MB-102 CAR-T cell investigational product.<br>* No investigational product will be administered.<br>|
| Prior MB-106 CAR-T cell investigational product.<br>Patients previously treated with MB-106 CAR-T cell investigational product. | Biological: Prior MB-106 CAR-T cell investigational product.<br>* No investigational product will be administered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AEs) | Incidence and characterization of adverse events (AEs) related to prior treatment with a Mustang Bio CAR-T cell investigational product received in a Mustang Bio sponsored clinical study. | Up to a total of 15 years | 
| Replication competent lentivirus (RCL) | Detection of replication competent lentivirus (RCL). | Up to a total of 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Overall Survival. | Up to a total of 15 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Long-term follow-up, CAR-T cell therapy, MB-102, MB-106