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
• Status: Enrolling by invitation
• 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
• 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.

Related Conditions & MeSH terms

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

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