CS1-CAR T Cells

CS1-CAR T Therapy Following Chemotherapy in Treating Patients With Relapsed or Refractory CS1 Positive Multiple Myeloma

What's the purpose of the trial?

This phase I trial studies the side effects and best dose of CS1-chimeric antigen receptor (CAR) T therapy after chemotherapy in treating patients who have CS1 positive multiple myeloma that has come back or does not respond to treatment. Immune cells can be engineered to kill multiple myeloma cells by inserting a piece of deoxyribonucleic acid (DNA) into the immune cells using a lentiviral vector such as CS1, that allows them to recognize multiple myeloma cells. It is not yet known whether these engineered immune cells, CS1-CAR T cells, will kill multiple myeloma cells.

OUTLINE: This is a dose-escalation study of CS1-CAR T cells.

Patients undergo leukapheresis over 2-4 hours. Beginning 3-4 weeks, patients receive cyclophosphamide intravenously (IV) on days -4 and/or -3 or fludarabine IV and cyclophosphamide IV on days -5 to -3. Patients then undergo CS1-CAR T therapy over 10-15 minutes on day 0. After 28 days, patients may undergo an optional second CS1-CAR T therapy.

After completion of study treatment, patients are followed up at 1 day, at least every 2 days for up to a minimum of 14 days, weekly for 1 month, monthly for 1 year, then periodically for up to 15 years.

Trial status

Accepting patients

Phase
Phase 1
Enrollment
30
Last Updated
3 months ago
Patient Screener

Participating Centers

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Experimental Treatments

Learn more about the experimental treatments being evaluated in this clinical trial.

  • Cyclophosphamide is a chemotherapy agent used in the treatment of cancer.
  • Fludarabine is a chemotherapy medication that may be used in the treatment of many different cancers.

Arms / Cohorts

Explore eligibility, treatments and learn more about potential cohorts.

Accepting patients

CS1-CAR T + Cyclophosphamide + Fludarabine

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