NCT06357754

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
151mo left

Started Oct 2023

Longer than P75 for all trials

Geographic Reach
4 countries

8 active sites

Status
recruiting

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 Progress17%
Oct 2023Oct 2038

Study Start

First participant enrolled

October 6, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
14.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2038

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2038

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

15 years

First QC Date

April 4, 2024

Last Update Submit

January 21, 2026

Conditions

Non-Hodgkin LymphomaChronic Lymphocytic LeukaemiaMultiple Myeloma

Outcome Measures

Primary Outcomes (2)

  • Participant in situ hybridization (ISH) or droplet-based digital Polymerase chain reaction (ddPCR) transgene testing results

    Baseline

  • Participant insertion site analysis (ISA) testing results

    For participants with positive in situ hybridization (ISH) transgene or droplet-based digital polymerase chain reaction (ddPCR) transgene

    Baseline

Study Arms (2)

Participants treated with idecabtagene vicleucel

Biological: Idecabtagene vicleucel

Participants treated with lisocabtagene maraleucel

Biological: Lisocabtagene maraleucel

Interventions

Idecabtagene vicleucelBIOLOGICAL

As per product label

Participants treated with idecabtagene vicleucel
Lisocabtagene maraleucelBIOLOGICAL

As per product label

Participants treated with lisocabtagene maraleucel

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants who receive a Bristol-Myers Squibb (BMS) manufactured Gene Modified Cell Therapy (GMCT) that have been diagnosed with a qualifying secondary malignancy

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Local Institution - 0016

Portland, Oregon, 97239-3098, United States

NOT YET RECRUITING

Ut Southwestern

Dallas, Texas, 75235, United States

RECRUITING

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Local Institution - 0004

Madison, Wisconsin, 53792, United States

WITHDRAWN

Universitaetsklinikum Essen (AoR)

Essen, 45147, Germany

RECRUITING

Toyokawa City Hospital

Toyokawa, Aichi-ken, 442-8561, Japan

RECRUITING

Local Institution - 0003

Kumamoto, Kumamoto, 8608556, Japan

WITHDRAWN

Kantonsspital Aarau

Aarau, 5001, Switzerland

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Acceptable sample types for transgene testing include: * Formalin fixed paraffin embedded (FFPE) tumor sample (twenty 4-5 μm freshly cut sections) * Bone marrow aspirate (up to 6mL. minimum of 4mL) * FFPE bone marrow biopsy (twenty 4-5 μm freshly cut sections) * Peripheral blood (6ml)

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLeukemia, B-CellMultiple Myeloma

Interventions

idecabtagene vicleucel

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidLeukemiaHematologic DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Central Study Contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

855-907-3286Clinical.Trials@bms.com

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

CONTACT

Study Design

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

Study Record Dates

First Submitted

April 4, 2024

First Posted

April 10, 2024

Study Start

October 6, 2023

Primary Completion (Estimated)

October 6, 2038

Study Completion (Estimated)

October 6, 2038

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

JP(2)US(4)CH(1)DE(1)