Search / Trial NCT06617572

Expanded Access Protocol (EAP) for Nonconforming (NC) Afami-cel

Launched by ADAPTIMMUNE · Sep 26, 2024

Trial Information

Current as of October 07, 2024

Available

Keywords

Description

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.

Locations

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

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0