T Cells Expressing a Novel Fully-Human Anti-BCMA CAR for Treating Multiple Myeloma Verified

What's the purpose of this trial?

This trial is testing the safety of using Anti-BCMA CAR-T Cells in myeloma.

This trial is currently open and accepting patients.


What's being studied?

  • Anti-BCMA CAR T Cells are your body’s own T cells that are removed during leukapheresis, altered in a lab by adding Chimeric Antigen Receptor (CAR) and an Anti-BCMA target, multiplied and then given back to you by intravenous infusion.
  • Cyclophosphamide is a chemotherapy agent used in the treatment of cancer.
  • Fludarabine is a chemotherapy agent used in the treatment of cancer.

What will happen during the trial?

This Phase 1 trial is being run in two different arms, dose escalation (Arm 1) and dose expansion (Arm 2). Arm 1 has completed enrollment and Arm 2 is now open and accepting patients. It is non-randomized, with sequential assignment, which means that the dose you receive, or the trial arm you enroll in, depend on when you join the trial. It is also open label, which means that both the researchers and you will know which dose you are receiving, or arm you are participating in.

ARM 1 (Completed)

  • This dose escalation arm has planned for five groups that will receive increasing doses of Anti-BCMA CAR-T Cells. The first patients enrolled will receive the smallest dose. Once that dose is determined to be safe, it will be increased for the next group of patients. Researchers in this arm are trying to determine the maximum tolerated dose with the least side effects. Five, four, and three days before receiving their CAR-T cells, patients will receive Cyclophosphamide, immediately followed by Fludarabine, both by intravenous infusion.
  • Patients will be admitted to the hospital in order to receive the Anti-BCMA CAR-T Cells, and must stay inpatient for at least 9 days after the infusion. Patients must stay within 60 minutes of the study center for two weeks after the infusion. Patients will be required to visit the study site for followups at 1, 2, 3, 4, 6, 9, and 12 months after infusion. As long as your myeloma doesn’t get worse, you will have to travel to the study site every 6 months for followup for up to five years.

ARM 2 (Open and Accepting Patients)

  • This arm of the trial will use the maximum tolerated dose of Anti-BCMA CAR-T Cells determined by the first arm. Five, four, and three days before receiving their CAR-T cells, patients will receive Cyclophosphamide, immediately followed by Fludarabine, both by intravenous infusion.
  • Patients will be admitted to the hospital in order to receive the Anti-BCMA CAR-T Cells, and must stay inpatient for at least 9 days after the infusion. Patients must stay within 60 minutes of the study center for two weeks after the infusion. Patients will be required to visit the study site for followups at 1, 2, 3, 4, 6, 9, and 12 months after infusion. As long as your myeloma doesn’t get worse, you will have to travel to the study site every 6 months for followup for up to five years.

Additional Trial Information

Phase 1

Enrollment: 42 patients (estimated)

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You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required. Create your account or call us today for help (888) 828-2206.

  • Your myeloma tests positive for the targeted BCMA.
  • You have had at least three prior treatments for your myeloma.
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Trial Locations

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Maryland

National Institutes of Health (NIH)

Bethesda, MD

Accepting

Trial Links

Read the latest news and updates on this trial.

Learn more about James N. Kochenderfer, M.D.

December 05, 2019

Dr. Kochenderfer is a physician-scientist working to develop immunotherapies for lymphoma, leukemia, and multiple myeloma. His current work focuses on chimeric antigen receptor T-cell therapies.

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