Cemacabtagene Ansegedleucel in Large B-Cell Lymphoma

What is the Purpose of this Study?

This study focuses on individuals with large B-cell lymphoma who have completed initial therapy. The study aims to determine whether CAR T cells made from healthy donors are an effective treatment to prevent relapse in people who have lymphoma DNA detected in their blood by an experimental test. CAR T cells are T cells (a type of immune system white blood cell) that have been engineered to attack cancer cells such as lymphoma. The study evaluates 2 experimental products: ALLO-647, an antibody (protein) that may help prepare the body for receiving CAR T cells from healthy donors and cemacabtagene ansegedleucel (cema-cel), a CAR T cell study treatment. ALLO-647 decreases certain white blood cells in the body in preparation to receive cema-cel. ALLO-647 may be given as part of a combination of drugs aimed at temporarily decreasing the white blood cells in the body. Cema-cel is made in the laboratory by taking white blood cells from a healthy person (donor) and changing them so they target lymphoma cells. The donor’s T-cells are genetically modified (changes are made to the DNA or genes) to help them fight or kill cancer cells. The study also evaluates an experimental laboratory test on the blood that looks for DNA specific to the patient’s lymphoma. Participants will be randomly assigned to either continued observation (the current standard of care) without any experimental drug treatment, or study treatment with cema-cel. If randomly assigned to study treatment, the participant may or may not receive ALLO-647.


Eligibility

  • 1. LBCL per WHO 2017 including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and primary mediastinal B-cell lymphoma histologically confirmed by pathology report.
  • 2. Participant has completed a full course of standard first line therapy (e.g., R-CHOP, dose-adjusted EPOCH-R, Pola-R-CHP) as intended. Participants cannot have received additional lines of therapy.
  • 3. Participant achieved CR, or PR suitable for observation at the end of first line therapy based on PET/CT evaluation
  • 4. Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™, is positive.
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Where can I participate?

CS Cancer at Cedars-Sinai Medical Center

More about this Clinical Trial

What is the full name of this clinical trial?

ALLO-501A-202: A Randomized, Open-Label Study Evaluating the Efficacy and Safety of, Cemacabtagene Ansegedleucel in Participants with Minimal Residual Disease after Response to First Line Therapy for Large B-Cell Lymphoma

Study Details
Disease Type/Condition

Other Hematopoietic

Principal Investigator

Merchant, Akil

Co-Investigators

Joshua Sasine, Justin Darrah

Age Group

Adult

Phase

III

IRB Number

STUDY00003519

ClinicalTrials.gov ID

NCT06500273

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other Hematopoietic

Principal Investigator

Merchant, Akil

Age Group

Adult

Phase

III

IRB Number

ALLO-501A-202

ClinicalTrials.gov ID

NCT06500273

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org