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

Part of paid clinical trials in Portland, Oregon.

Sponsor
Bristol-Myers Squibb
Study ID
NCT06357754
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Idecabtagene vicleucel — BIOLOGICAL
    As per product label
  • Lisocabtagene maraleucel — BIOLOGICAL
    As per product label

Study Details

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.

Key Dates

First listed
Apr 10, 2024
Start date
Oct 6, 2023
Status verified
Jan 2026
Primary completion
Oct 6, 2038
Completion
Oct 6, 2038

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Participants treated with idecabtagene vicleucel
  • Arm: Participants treated with lisocabtagene maraleucel

Primary Outcome Measure

Participant in situ hybridization (ISH) or droplet-based digital Polymerase chain reaction (ddPCR) transgene testing results [ Time Frame: Baseline ]

Central Contacts

  • BMS Study Connect Contact Center www.BMSStudyConnect.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (4)

FacilityCityStateZIPSite coordinators
Local Institution - 0016PortlandOregon97239-3098
Site 0016
Ut SouthwesternDallasTexas75235
Larry Anderson, Site 0008
214-648-5906
Huntsman Cancer Institute at the University of UtahSalt Lake CityUtah84112
Lauren Lee, Site 0010
Local Institution - 0004MadisonWisconsin53792-

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