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

Sponsor

Mustang Bio (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05645744

Collaborator

(none)

331

Enrollment

Locations

237

Anticipated Duration (Months)

66.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Biological: Prior MB-102 CAR-T cell investigational product. Biological: Prior MB-106 CAR-T cell investigational product.

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 Design

Study Type:

Observational

Anticipated Enrollment :

331 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 29, 2021

Anticipated Primary Completion Date :

Apr 1, 2041

Anticipated Study Completion Date :

Jul 1, 2041

Arms and Interventions

Arm	Intervention/Treatment
Prior MB-102 CAR-T cell investigational product. Patients previously treated with MB-102 CAR-T cell investigational product.	Biological: Prior MB-102 CAR-T cell investigational product. No investigational product will be administered.
Prior MB-106 CAR-T cell investigational product. Patients previously treated with MB-106 CAR-T cell investigational product.	Biological: Prior MB-106 CAR-T cell investigational product. No investigational product will be administered.

Arm

Intervention/Treatment

Prior MB-102 CAR-T cell investigational product.

Patients previously treated with MB-102 CAR-T cell investigational product.

Biological: Prior MB-102 CAR-T cell investigational product.

No investigational product will be administered.

Prior MB-106 CAR-T cell investigational product.

Patients previously treated with MB-106 CAR-T cell investigational product.

Biological: Prior MB-106 CAR-T cell investigational product.

No investigational product will be administered.

Outcome Measures

Primary Outcome Measures

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

Survival [Up to a total of 15 years]
Overall Survival.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope Medical Center	Duarte	California	United States	91010
2	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
3	Duke University	Durham	North Carolina	United States	27710
4	MD Anderson Cancer Center	Houston	Texas	United States	77030
5	Fred Hutchinson Cancer Center	Seattle	Washington	United States	98109