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Transgene Assay Testing Service of Tumor Samples From Patients Who Received a Bristol-Myers Squibb Manufactured Gene Modified Cell Therapy and Have a Qualifying Second Primary Malignancy

NCT ID: NCT06357754

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-06

Study Completion Date

2038-10-06

Brief Summary

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The purpose of this transgene assay testing service is to evaluate tumor samples for transgene levels in patients who received a commercially available Bristol-Myers Squibb manufactured gene modified cellular therapy and have reported a qualifying second malignancy.

Detailed Description

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Conditions

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Non-Hodgkin Lymphoma Chronic Lymphocytic Leukaemia Multiple Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants treated with idecabtagene vicleucel

Idecabtagene vicleucel

Intervention Type BIOLOGICAL

As per product label

Participants treated with lisocabtagene maraleucel

Lisocabtagene maraleucel

Intervention Type BIOLOGICAL

As per product label

Interventions

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Idecabtagene vicleucel

As per product label

Intervention Type BIOLOGICAL

Lisocabtagene maraleucel

As per product label

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Participant has received a commercially available Bristol-Myers Squibb (BMS) manufactured Gene Modified Cell Therapy (GMCT) and has been diagnosed with a qualifying second primary malignancy or a second primary malignancy which BMS has qualified for testing.
* Participant has received a commercially available BMS manufactured GMCT in a clinical trial or other investigational setting (including non-conforming product) for which there is no testing protocol in place for that trial or investigational setting and has been diagnosed with a qualifying second primary malignancy or a second primary malignancy which BMS has qualified for testing.

Exclusion Criteria

* Participant is actively participating in a clinical trial where information and sample collection is being conducted under that clinical trial.
* Participant has not received a BMS manufactured GMCT or has not been diagnosed with a qualifying second primary malignancy.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0008

Dallas, Texas, United States

Site Status NOT_YET_RECRUITING

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, United States

Site Status RECRUITING

Local Institution - 0004

Madison, Wisconsin, United States

Site Status WITHDRAWN

Universitaetsklinikum Essen (AoR)

Essen, , Germany

Site Status RECRUITING

Toyokawa City Hospital

Toyokawa, Aichi-ken, Japan

Site Status RECRUITING

Local Institution - 0003

Kumamoto, Kumamoto, Japan

Site Status WITHDRAWN

Kantonsspital Aarau

Aarau, , Switzerland

Site Status RECRUITING

Countries

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Belgium United States Germany Japan Switzerland

Central Contacts

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BMS Study Connect Contact Center www.BMSStudyConnect.com

Role: CONTACT

Phone: 855-907-3286

Email: [email protected]

First line of the email MUST contain NCT # and Site #.

Role: CONTACT

Facility Contacts

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Site 0008

Role: primary

Lauren Lee, Site 0010

Role: primary

Bastian von Tresckow, Site 0001

Role: primary

Akimi Kawai, Site 0012

Role: primary

Sabine Veronika Gerull, Site 0002

Role: primary

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

FDA Safety Alerts and Recalls

Other Identifiers

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CA082-085

Identifier Type: -

Identifier Source: org_study_id