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CRIPSR-Cas9-edited CAR T cells (CTX131) to treat acute myeloid leukemia (AML), lymphoma or myelodysplastic syndrome (MDS) that has come back (relapsed) or not gotten better with treatment (refractory)

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18 - 100

Phase 1, Phase 2

6 Locations

NCT06492304

Clinical Trial Goal


To find out:
  • The highest dose of CTX131 that's safe to give
  • If CTX131 is safe and works well to treat AML, lymphoma or MDS that has relapsed or is refractory

You may be able to join this trial if you:


  • Are 18 years or older
  • Have one of the following that has relapsed or is refractory:
    • AML
    • Lymphoma. Some examples include:
      • B-cell lymphoma
      • Diffuse large B-cell lymphoma (DLBCL)
      • Follicular lymphoma, grade 3b
      • Mantle cell lymphoma (MCL)
      • Marginal zone lymphoma (MZL)
      • T-cell lymphoma
      • Transformed lymphoma
    • MDS
  • Do not have lymphoma in your brain or spinal cord
  • Have not had allogeneic (cells from a donor) blood or marrow transplant (BMT) in the last 3 months
  • Have not been treated with a drug that targets CD70. Your doctor can tell you this
  • Have not been treated with CAR T cell therapy that targets CD19 in the last 6 months. Your doctor can tell you this
  • Agree to have other standard tests done to see if you can be in the clinical trial

Trial Details


CAR stands for chimeric antigen receptors and T stands for T cells, a type of immune cell. This treatment helps your own immune system find and destroy cancer cells.
CTX131 is a type of CAR T-cell therapy that targets CD70 on certain cells. CTX131 uses donor T-cells that are genetically modified in lab, using CRISPR-Cas9 gene editing technology.

To make CAR T cells, T cells are collected from a donor by apheresis. Apheresis is a process to collect cells from the bloodstream using a needle similar to when you donate blood. The T cells are genetically modified to grow special proteins called CARs. CARs help T cells find the cancer cells. The CAR T cells are grown in a lab until there are millions of them. Then, they’re given back to you to find and destroy the cancer cells.
 
The CAR T cells are given to you through an IV infusion. The dose of cells you’ll get depends on when you start the trial and how safe it has been.

The clinical trial doctors will watch you closely for up to 5 years. You'll have biopsies and/or scans to see how well the treatment is working. The clinical trial doctors will check your health for up to 15 years.

The Food and Drug Administration (FDA) has not yet approved CTX131. 

Watch a video about CAR T-Cell Therapy

Contacts


Clinical Trials, +1 877-214-4634, medicalaffairs@crisprtx.com

Locations

Research Site 6RECRUITING

Phoenix, Arizona

Research Site 5RECRUITING

Stanford, California

Research Site 3RECRUITING

Boston, Massachusetts

Research Site 2RECRUITING

The Bronx, New York

Research Site 4RECRUITING

New York, New York

Research Site 1RECRUITING

Houston, Texas

ClinicalTrials.gov record


NCT06492304. First posted on 7/9/24

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