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Joint Clinical Trials Office

Expanded Access Study for the Treatment of Patients with Commercially Out-of-Specification Axicabtagene Ciloleucel

Clinical Trial Details

The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with large B-cell lymphoma and follicular lymphoma approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.

Axicabtagene ciloleucel is considered investigational, which means it has not been approved by the U.S. Food and Drug Administration (FDA). 

All participants will undergo screening, then receive a Lymphodepleting Chemotherapy for 3 days. Following that, they will receive the a single infusion of the chimeric antigen receptor (CAR)-T cell study drug intravenously (through an IV). All participants will receive the same dose. 

The participant will be in the program until 30 days after they receive Axicabtagene Ciloleucel.

Key Eligibility: 

Inclusion Criteria

  1. Diagnosed with Large B-cell Lymphoma or Follicular Lymphoma
  2. Have commercially manufactured axicabtagene ciloleucel that does not meet commercial release criteria but does meet Kite clinical trial release criteria
  3. Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been post-menopausal for at least 2 years are not considered to be of childbearing potential)
  4. In the investigator's opinion, there is no satisfactory alternative therapy available to the individual


Exclusion Criteria

  1.  Primary central nervous system lymphoma

Detailed eligibility will be discussed when reaching out to the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Jerome Castaneda
212-746-1362
jec4027@med.cornell.edu

Primary Investigator(s)

Samuel Yamshon, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2402027118

ClinicalTrials.gov:

NCT05776160

Sponsor:

KT-US-471-0140

Status

Open to Enrollment

Age Group

Adult

Sponsor

  • Kite Pharma, Inc.

Disease

Lymphoma
Diffuse Large B-Cell Lymphoma
Follicular Lymphoma