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

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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