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

Terminated

• Conditions: Waldenstrom's Macroglobulinemia Recurrent; Follicular B-cell Non-Hodgkin's Lymphoma; Mantle Cell Lymphoma Recurrent; Diffuse Large B Cell Lymphoma; Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN); Chronic Lymphocytic Leukemia in Relapse; B-cell Lymphoma Refractory; Hairy Cell Leukemia; Mantle Cell Lymphoma Refractory; Small Lymphocytic Lymphoma, Relapsed
• Interventions: Biological: Prior MB-106 CAR-T cell investigational product.; Biological: Prior MB-102 CAR-T cell investigational product.

• Registration Number: NCT05645744
• Lead Sponsor: Mustang Bio

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-09-29
• Study First Submitted: 2022-12-01
• Study First Submitted QC: 2022-12-08
• Study First Posted: 2022-12-09
• Status Verified: 2024-01
• Primary Completion: 2024-04-12
• Study Completion: 2024-04-12
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prior MB-106 CAR-T cell investigational product.	Prior MB-106 CAR-T cell investigational product.	Patients previously treated with MB-106 CAR-T cell investigational product.
Prior MB-102 CAR-T cell investigational product.	Prior MB-102 CAR-T cell investigational product.	Patients previously treated with MB-102 CAR-T cell investigational product.

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs)	Up to a total of 15 years	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.
Replication competent lentivirus (RCL)	Up to a total of 15 years	Detection of replication competent lentivirus (RCL).

Secondary Outcome Measures

Name	Time	Method
Survival	Up to a total of 15 years	Overall Survival.

Trial Locations

Locations (5)

Fred Hutchinson Cancer Center; 🇺🇸 Seattle, Washington, United States

UC Irvine Health - Chao Family Comprehensive Cancer Center; 🇺🇸 Orange, California, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States