A Phase IB Study of CAR T-Cell Therapy in People with Advanced Stomach or Pancreatic Cancers

Full Title

Open-label, Multicenter, Phase 1b/2 clinical trial to evaluate the safety and efficacy of autologous anti-claudin18.2 chimeric antigen receptor T-cell therapy in patients with advanced gastric, pancreatic, or other specified digestive system cancers

Purpose

CAR T-cell therapy is a type of cellular therapy that involves using a patient’s own T cells (a type of white blood cell), genetically modifying them in the laboratory to recognize a protein on cancer cells, and multiplying them. The modified T cells, known as “chimeric antigen receptor” (CAR) T cells, are then returned to the patient to find and kill cancerous cells throughout the body.

In this study, researchers are seeking to find the best dose of a CAR T-cell therapy called CT041 that can be given safely in people with advanced gastric (stomach) cancer or pancreatic cancer that contains a protein called CLDN18.2. CT041 is designed to attack cancer cells containing this protein. To determine if a patient’s cancer cells have the CLDN18.2 protein, cancer cells from a previous biopsy or surgery must first be tested during the screening phase of this study.

CT041 is given intravenously during a hospital stay of at least 1 week. For 4 weeks after leaving the hospital, patients must reside within one hour of Memorial Sloan Kettering Cancer Center in case there are any side effects that require medical attention.

Who Can Join

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

• Participants must have advanced gastric or pancreatic cancer that has continued to grow despite prior treatment.
• Patients’ tumors must contain the CLDN18.2 protein (as determined by a test during the screening phase of the study).
• The serious side effects of previous therapies must go away before CT041 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 between the ages of 18 and 80.

For more information about this study and to ask about eligibility, please contact the office of Dr. Geoffrey Ku at 646-888-4588.