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

Trial ID or NCT#

NCT06617572

Status

not recruiting iconNOT 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

Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
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Investigator(s)

Nam Quoc Bui
Nam Quoc Bui
Medical oncologist, Sarcoma specialist
Clinical Associate Professor, Medicine - Oncology
Lekha Mikkilineni
Lekha Mikkilineni
Medical oncologist
Assistant Professor of Medicine (Blood and Marrow Transplantation & Cellular Therapy)
Allison Betof
Allison Betof
Cutaneous oncology specialist, Melanoma specialist, Medical oncologist
Associate Professor of Medicine (Oncology)
Lori Muffly
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)
Saurabh Dahiya
Saurabh Dahiya
Hematologist-Oncologist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Sally Arai
Sally Arai
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Minggui Pan
Minggui Pan
Medical oncologist, Sarcoma specialist
Clinical Professor, Medicine - Oncology
Melody Smith
Melody Smith
Hematologist-Oncologist
Assistant Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Surbhi Sidana
Surbhi Sidana
Blood and marrow transplant specialist, Hematologist-Oncologist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Kristen N Ganjoo
Kristen N Ganjoo
Sarcoma specialist, Medical oncologist
Professor of Medicine (Oncology)
David B Miklos
David B Miklos
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Hematologist, Medical oncologist
James and Katherine Lau Professor
Vanessa Kennedy
Assistant Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Wen-Kai Weng
Wen-Kai Weng
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Lymphoma specialist, Medical oncologist, Multiple myeloma specialist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology
Laura Johnston
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
Andrew R Rezvani
Andrew R Rezvani
Blood and marrow transplant specialist, Blood and marrow transplant specialist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Robert S Negrin
Robert S Negrin
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Sushma Bharadwaj
Sushma Bharadwaj
Hematologist
Clinical Assistant Professor, Medicine - Blood & Marrow Transplantation
Everett Meyer
Everett Meyer
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Hematologist, Transplant immunologist, Hematologist-Oncologist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy), of Pediatrics (Stem Cell Transplantation) and, by courtesy, of Surgery (Abdominal Transplantation)
Matthew Frank
Blood and marrow transplant specialist, Hematologist-Oncologist
Assistant Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Parveen Shiraz
Parveen Shiraz
Blood and marrow transplant specialist, Hematologist-Oncologist
Instructor, Medicine - Blood & Marrow Transplantation
Robert Lowsky
Robert Lowsky
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist
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