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NCT05645744 Clinical Trial

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

Diffuse Large B Cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05645744
Other study ID # MB100-OBS-001
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date September 29, 2021
Est. completion date July 2041

Study information
Verified date March 2023
Source Mustang Bio
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 331
Est. completion date July 2041
Est. primary completion date April 2041
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• Prior MB-102 CAR-T cell investigational product.
No investigational product will be administered.
• Prior MB-106 CAR-T cell investigational product.
No investigational product will be administered.

Locations
Country Name City State
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Cleveland Clinic Cleveland Ohio
United States City of Hope Medical Center Duarte California
United States Duke University Durham North Carolina
United States MD Anderson Cancer Center Houston Texas
United States Fred Hutchinson Cancer Center Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
Mustang Bio

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary Replication competent lentivirus (RCL) Detection of replication competent lentivirus (RCL). Up to a total of 15 years
Secondary Survival Overall Survival. Up to a total of 15 years
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