A Phase 1 Study of SYNCAR-001 Plus STK-009 in People With Blood Cancers

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Full Title

A Phase 1 Study to Evaluate the Safety and Tolerability of a Combination Autologous CD19 CAR T Cell Therapy (SYNCAR-001 + STK-009) in Subjects With Relapsed or Refractory CD19+ Hematologic Malignancies

Purpose

Researchers in this study are seeking the best dose of STK-009 to give with SYNCAR-001 in people with blood cancers. Examples of blood cancers include leukemia and lymphoma. The people in this study have blood cancers that came back or keep growing even after treatment. STK-009 plus SYNCAR-001 helps your immune system fight cancer.

SYNCAR-001 is made from your own white blood cells called T cells. Some of your T cells will be taken and sent to a lab. In the lab, they will be changed so they can detect and destroy cancer cells. T cell therapies like SYNCAR-001 are called CAR T cell therapies. This treatment is given intravenously (by vein).

STK-009 may make SYNCAR-001 work better. It is given as an injection under the skin.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have a B cell cancer that came back or keeps growing after treatment. Examples include chronic lymphocytic leukemia, small lymphocytic lymphoma, and non-Hodgkin lymphoma (diffuse large B cell carcinoma, follicular lymphoma, mantle cell lymphoma, and marginal zone lymphoma).
  • Have a cancer that has a protein called CD19.
  • Have completed prior cancer treatment at least 2 weeks before getting the study treatment.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 or older.

Contact

For more information and to see if you can join this study, please call Dr. M. Lia Palomba’s office at 646-608-2091.

Protocol

23-064

Phase

Phase I (phase 1)

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05665062