A Phase I Clinical Trial of T Cells Expressing an Anti-SLAMF7 CAR for Treating Multiple Myeloma

What is the purpose of this trial?

This trial is testing the safety of Anti-SLAMF7 CAR-T cells in myeloma. The Anti-SLAMF7 CAR-T cells in this trial are altered to include a ‘stop switch’, to help limit toxicity of this therapy.

This trial is currently open and accepting patients.


Treatments included in this clinical trial:

  • Anti-SLAMF7 CAR T Cells are a novel type of CAR-T cell therapy. SLAMF7 is a receptor present in high numbers on myeloma cells but usually absent on normal tissues. Your own T cells are removed by leukapheresis, altered in a lab by adding Chimeric Antigen Receptors (CAR) targeting SLAMF7, 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.
  • Rimiducid is a drug that activates the 'stop switch' built into Anti-SLAMF7 CAR T cells. This can cause the Anti-SLAMF7 CAR-T cells to deactivate and die in the event of toxic side effects.

What will happen during the trial?

This Phase 1 trial is being run in two different arms, dose escalation and dose expansion. 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:

  • This dose escalation arm has planned for five groups that will receive increasing doses of Anti-SLAMF7 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-SLAMF7 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 three years.

ARM 2:

  • This arm of the trial will use the maximum tolerated dose of Anti-SLAMF7 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-SLAMF7 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 three years.

If patients develop bad side effects from the Anti-SLAMF7, researchers can decide to give them Rimiducid by intravenous infusion to cause cell death of the Anti-SLAMF7 CAR-T cells.


Additional Trial Information

Phase 1

Enrollment: 42 patients (estimated)

View More

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.

  • You’ve been diagnosed with multiple myeloma.
  • You have received at least three lines of treatment for your myeloma.
  • You must be between the ages of 18 and 73
  • Patients receiving prior gene therapy outside of NIH will not be eligible. Patients who previously received CAR T-cell therapy at the NCI will be potentially eligible.
  • Patients with prior allogeneic stem cell transplant are not eligible
View Additional Criteria

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

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.

Read more
Interested in this trial?
  • Call us today 😀 keyboard_arrow_right

    We know how difficult and confusing this process can be. If you are interested in this clinical trial or have questions, you can call us at any time. You can also send us a direct message with questions.

    (888) 828-2206
  • If you are interested in keeping an eye on this trial, you can add it to your list of favorite trials. We'll send you alerts when this trial is updated.

  • Talk to your doctor keyboard_arrow_right

    You can print an overview of this trial to take in to your next appointment. Your doctor can help you understand if this trial may be right for you.

Still need help? Send us a message