Study on the Safety and Effectiveness of CTX131 for Adults with Difficult-to-Treat Blood Cancers

Sponsor: CRISPR Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06492304

Provider View

This clinical trial is testing a new treatment called CTX131, which uses modified immune cells to target and fight blood cancers that have not responded to previous treatments or have returned.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of CTX131, a new type of immunotherapy, in adults with blood cancers that have come back or are not responding to treatment. CTX131 is made from healthy donor immune cells that are genetically modified to target cancer cells.

Description

This study will include up to 290 participants. CTX131 is a type of CAR T-cell therapy, which uses immune cells from healthy donors that are modified in the lab to target and destroy cancer cells. The cells are changed using a technology called CRISPR-Cas9, which allows precise genetic editing. The goal is to see if this treatment is safe and can help reduce or eliminate blood cancers that have not responded to other treatments.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a good overall health status, with a performance score of 0-1 (or 2 for those with Acute Myeloid Leukemia).
  • Diagnosed with certain types of blood cancers, such as T Cell Lymphoma, B Cell Lymphoma, or Acute Myeloid Leukemia, and have tried previous treatments without success.
  • Have good kidney, liver, heart, and lung function.
  • Women who can become pregnant and men must agree to use effective birth control during the study and for 12 months after the last treatment.

Exclusion Criteria

  • Have had previous treatments targeting CD70.
  • Have active cancer in the brain or spinal cord.
  • Have a history of serious brain or nerve conditions that could increase the risk of side effects.
  • Have uncontrolled infections.
  • Test positive for HIV, hepatitis B, or hepatitis C.
  • Have received certain cancer treatments recently, including specific drugs or therapies.
  • Have been diagnosed with another invasive cancer in the past 5 years, except for certain skin cancers.
  • Have immune system disorders or active autoimmune diseases requiring treatment.
  • Have had a solid organ or bone marrow transplant, with some exceptions for those with AML.
  • Have received CD19-targeting CAR-T therapy within the last 6 months.

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