A Phase I Study of ALLO-647 and ALLO-316 CAR T-Cell Therapy in People with Advanced Kidney Cancer

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Full Title

A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ALLO-316 Following ALLO-647 Containing Conditioning Regimen in Subjects with Advanced or Metastatic Clear Cell Renal Cell Carcinoma (ccRCC)

Purpose

The purpose of this study is to assess the safety of the investigational drugs ALLO-647 and ALLO-316 in people with advanced clear cell renal cell (kidney) cancer. ALLO-647 is an antibody designed to target some kinds of white blood cells. It will be given in combination with a standard chemotherapy regimen (fludarabine and cyclophosphamide) to prepare patients to receive ALLO-316.

ALLO-316 is made in a laboratory from white blood cells (T cells) collected from a healthy donor and is a form of cellular therapy. These cells are modified (“CAR T cells”) to help the immune system recognize and kill kidney cancer cells. ALLO-647 will help ALLO-316 work better by reducing the immune system’s ability to fight the modified T cells.

Participants in this study will receive standard chemotherapy with or without ALLO-647, followed by ALLO-316. All medications are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have inoperable or metastatic clear cell renal cell carcinoma that has continued to grow despite treatment.
  • The serious side effects of previous therapies should go away before the study treatment is given.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people ages 18-74.

For more information and to ask about eligibility for this study, please contact the office of Dr. Ritesh Kotecha at 646-422-4839.

Protocol

21-258

Phase

I

Investigator