What this study is
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.
What's being tested
- Idecabtagene vicleucel
Intervention · BIOLOGICAL
- Lisocabtagene maraleucel
Intervention · BIOLOGICAL
Both interventions
As per product label
Study details
- Official title
- Protocol for Transgene Assay Service
- Sponsor
- Bristol-Myers Squibb
- Conditions
- Non-Hodgkin Lymphoma · Chronic Lymphocytic Leukaemia · Multiple Myeloma
- Enrolling
- 50 people
- Starts
- 2023-10-06
- Est. completion
- 2038-10-06
- Record
- View on ClinicalTrials.gov ↗
Who can join
Sex ALLHealthy volunteers Not acceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (8)
6 openLocal Institution - 0016
Portland, Oregon, United States
- Site 0016 · Contact
Not yet recruiting- Recruiting
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, United States
- Lauren Lee, Site 0010 · Contact
RecruitingLocal Institution - 0004
Madison, Wisconsin, United States
Withdrawn
4 sites outside the US
Universitaetsklinikum Essen (AoR)
Essen, Germany
- Bastian von Tresckow, Site 0001 · Contact+491631751277
RecruitingToyokawa City Hospital
Toyokawa, Aichi-ken, Japan
- Akimi Kawai, Site 0012 · Contact
Recruiting- Recruiting
Local Institution - 0003
Kumamoto, Kumamoto, Japan
Withdrawn
Study team
Sponsor
Bristol-Myers Squibb
Study ID CA082-085
Study director
Bristol-Myers Squibb
Bristol-Myers Squibb
CONTACT
First line of the email MUST contain NCT # and Site #.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.