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

March 9, 2023 updated by: Mustang Bio

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

331

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients previously treated with a Mustang Bio CAR-T cell investigational product in a Mustang Bio sponsored clinical study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events (AEs)
Time Frame: 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.
Up to a total of 15 years
Replication competent lentivirus (RCL)
Time Frame: Up to a total of 15 years
Detection of replication competent lentivirus (RCL).
Up to a total of 15 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mustang Bio

Investigators

  • Study Director: Bruce Dezube, M.D., Mustang Bio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2021

Primary Completion (Anticipated)

April 1, 2041

Study Completion (Anticipated)

July 1, 2041

Study Registration Dates

First Submitted

December 1, 2022

First Submitted That Met QC Criteria

December 8, 2022

First Posted (Actual)

December 9, 2022

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB100-OBS-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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