Expanded Access Protocol (EAP) for Nonconforming (NC) Afami-cel
Launched by ADAPTIMMUNE · Sep 26, 2024
Trial Information
Current as of July 01, 2025
Available
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patient must provide written informed consent prior to participating in this protocol
- • 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:
- • Patient has contraindication(s) as per the TECELRA® USPI
- • Do not use TECELRA® in adults who are heterozygous or homozygous for HLA-A\*02:05P
About Adaptimmune
Adaptimmune is a clinical-stage biopharmaceutical company specializing in the development of innovative T-cell therapies for cancer treatment. Leveraging its proprietary SPEAR T-cell platform, Adaptimmune aims to harness the power of the immune system to target and eliminate cancer cells with precision. The company is focused on advancing its pipeline of engineered T-cell therapies through rigorous clinical trials, demonstrating a commitment to improving patient outcomes in oncology. With a strong emphasis on scientific excellence and collaboration, Adaptimmune is dedicated to transforming the landscape of cancer immunotherapy.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Philadelphia, Pennsylvania, United States
Boston, Massachusetts, United States
Houston, Texas, United States
Stanford, California, United States
Tampa, Florida, United States
Boston, Massachusetts, United States
Jacksonville, Florida, United States
Rochester, Minnesota, United States
New York, New York, United States
Phoenix, Arizona, United States
Chicago, Illinois, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported