A Phase I Study of CTX130 Immunotherapy in People with Persistent or Recurrent T-Cell or B-Cell Cancers

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Full Title

A Phase 1, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD70 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX130) in Adult Subjects With Relapsed or Refractory T or B Cell Malignancies

Purpose

The purpose of this study is to find the highest dose of the investigational immunotherapy CTX130 that can be given safely in patients with T-cell and B-cell cancers that came back or continued to grow despite treatment. CTX130 is made in a laboratory from white blood cells called T cells that were collected from a healthy donor and modified using a gene-editing tool called CRISPR/Cas9.

CTX130 is designed to target and destroy the CD70 protein found on the surface of patients’ cancer cells. It is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a recurrent or persistent T-cell or B-cell cancer following prior anticancer therapy. Examples include cutaneous T-cell lymphoma, anaplastic large cell lymphoma, adult T-cell leukemia-lymphoma, mycosis fungoides, Sézary syndrome, angioimmunoblastic T-cell lymphoma, and diffuse large B-cell lymphoma.
  • Patients’ cancers must contain the CD70 protein.
  • At least 2 weeks must pass since the completion of prior cancer treatment and receipt of CTX130.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Steven Horwitz at 646-608-3725.

Protocol

21-180

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators