Expanded Access Protocol (EAP) for Nonconforming (NC) Afami-cel
Trial ID or NCT#
NCT06617572
Status
NOT RECRUITING
Purpose
The purpose of this expanded access protocol (EAP) is to provide controlled access to Afamitresgene autoleucel, suspension for intravenous infusion that does not meet the commercial release specification (NC afami-cel). This EAP will be conducted at authorized treatment centers where TECELRA® is being administered and where the EAP is approved to be conducted. Patients who are prescribed TECELRA® , sign the informed consent form, and meet all entry criteria will be eligible to participate in this protocol.
Official Title
Expanded Access Protocol for Product Which Does Not Conform to the TECELRA® (Afamitresgene Autoleucel, Suspension for Intravenous Infusion) Commercial Release Specification
Eligibility Criteria
Ages Eligible for Study: Older than 18
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
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 per consultation with USWM CT* 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
Investigator(s)
Nam Quoc Bui
Medical oncologist,
Sarcoma specialist
Clinical Associate Professor, Medicine - Oncology
Sushma Bharadwaj
Hematologist
Clinical Assistant Professor, Medicine - Blood & Marrow Transplantation
Andrew R Rezvani
Blood and marrow transplant specialist,
Blood and marrow transplant specialist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Matthew Frank
Blood and marrow transplant specialist,
Hematologist-Oncologist
Assistant Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Parveen Shiraz
Blood and marrow transplant specialist,
Hematologist-Oncologist
Instructor, Medicine - Blood & Marrow Transplantation
Sally Arai
Blood and marrow transplant specialist,
Hematologist,
Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Allison Betof
Cutaneous oncology specialist,
Melanoma specialist,
Medical oncologist
Associate Professor of Medicine (Oncology)
Surbhi Sidana
Blood and marrow transplant specialist,
Hematologist-Oncologist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Wen-Kai Weng
Blood and marrow transplant specialist,
Blood and marrow transplant specialist,
Lymphoma specialist,
Medical oncologist,
Multiple myeloma specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology
Everett Meyer
Blood and marrow transplant specialist,
Blood and marrow transplant specialist,
Hematologist,
Transplant immunologist,
Hematologist-Oncologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Robert Lowsky
Blood and marrow transplant specialist,
Hematologist,
Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Vanessa Kennedy
Assistant Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Laura Johnston
Blood and marrow transplant specialist,
Blood and marrow transplant specialist,
Medical oncologist,
Hematologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy), Emerita
Lekha Mikkilineni
Medical oncologist
Assistant Professor of Medicine (Blood and Marrow Transplantation & Cellular Therapy)
David B Miklos
Blood and marrow transplant specialist,
Blood and marrow transplant specialist,
Hematologist,
Medical oncologist
James and Katherine Lau Professor
Robert S Negrin
Blood and marrow transplant specialist,
Hematologist,
Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Saurabh Dahiya
Hematologist-Oncologist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Lori Muffly
Hematologist,
Blood and marrow transplant specialist,
Blood and marrow transplant specialist,
Hematologist-Oncologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Melody Smith
Hematologist-Oncologist
Assistant Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Contact us to find out if this trial is right for you.
Contact
Melanie G San Pedro-Salcedo
650-724-1388
View on ClinicalTrials.gov
