Expanded Access Protocol (EAP) for Nonconforming (NC) Afami-cel
NCT ID: NCT06617572
Last Updated: 2024-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
AVAILABLE
EXPANDED_ACCESS
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Non-conforming afamitresgene autoleucel
Non-conforming afamitresgene autoleucel, suspension for intravenous infusion (NC afami-cel), single dose administration
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient must have been prescribed TECELRA®
* Patient's commercially manufactured product does not meet the commercial release specification
* Repeat manufacture is not feasible or is not clinically appropriate per Investigator assessment in consultation with Adaptimmune
* Repeat leukapheresis is not feasible or is not clinically appropriate per Investigator assessment
* The Investigator has confirmed a favorable benefit:risk profile, following sponsor evaluation of the NC afami-cel, and deems proceeding with treatment under this EAP is in the best interest of the patient
* Patient deemed medically fit and stable to receive NC afami-cel per Investigator assessment
* Female patients with reproductive potential must have a negative serum or urine pregnancy test within 7 days of initiating lymphodepleting chemotherapy
Exclusion Criteria
* Do not use TECELRA® in adults who are heterozygous or homozygous for HLA-A\*02:05P
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Adaptimmune
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Arizona
Phoenix, Arizona, United States
Stanford Hospital and Clinics
Stanford, California, United States
Mayo Florida
Jacksonville, Florida, United States
Moffit Cancer Center
Tampa, Florida, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Rochester
Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Centre
New York, New York, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ADP-0044-999
Identifier Type: -
Identifier Source: org_study_id