NCT05645744

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 29, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2024

Completed
Last Updated

July 22, 2024

Status Verified

January 1, 2024

Enrollment Period

2.5 years

First QC Date

December 1, 2022

Last Update Submit

July 18, 2024

Conditions

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)Chronic Lymphocytic Leukemia in RelapseSmall Lymphocytic Lymphoma, RelapsedWaldenstrom's Macroglobulinemia RecurrentFollicular B-cell Non-Hodgkin's LymphomaB-cell Lymphoma RefractoryMantle Cell Lymphoma RecurrentHairy Cell LeukemiaDiffuse Large B Cell LymphomaWaldenstrom's Macroglobulinemia RefractoryMantle Cell Lymphoma Refractory

Keywords

Long-term follow-upCAR-T cell therapyMB-102MB-106

Outcome Measures

Primary Outcomes (2)

  • 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

  • Replication competent lentivirus (RCL)

    Detection of replication competent lentivirus (RCL).

    Up to a total of 15 years

Secondary Outcomes (1)

  • Survival

    Up to a total of 15 years

Study Arms (2)

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.

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.

Interventions

Prior MB-102 CAR-T cell investigational product.BIOLOGICAL

No investigational product will be administered.

Prior MB-102 CAR-T cell investigational product.
Prior MB-106 CAR-T cell investigational product.BIOLOGICAL

No investigational product will be administered.

Prior MB-106 CAR-T cell investigational product.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

UC Irvine Health - Chao Family Comprehensive Cancer Center

Orange, California, 92868-3201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood

MeSH Terms

Conditions

Blastic Plasmacytoid Dendritic Cell NeoplasmLeukemia, Lymphocytic, Chronic, B-CellRecurrenceLeukemia, Hairy CellLymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Histiocytic Disorders, MalignantNeoplasms by Histologic TypeNeoplasmsLeukemiaLymphomaHematologic NeoplasmsNeoplasms by SiteSkin NeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLeukemia, B-CellLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, B-CellLymphoma, Non-Hodgkin

Study Officials

  • Bruce Dezube, M.D.

    Mustang Bio

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2022

First Posted

December 9, 2022

Study Start

September 29, 2021

Primary Completion

April 12, 2024

Study Completion

April 12, 2024

Last Updated

July 22, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(5)