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Plasma Cell Myelomas - Healing Genes
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Plasma Cell Myelomas

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

Phase I Study to Evaluate Cellular Immunotherapy Using Memory-Enriched T Cells Lentivirally Transduced to Express a CS1-Targeting, Hinge-Optimized, 41BB-Costimulatory Chimeric Antigen Receptor and a Truncated EGFR Following Lymphodepleting Chemotherapy in Adult Patients With CS1+ Multiple Myeloma


Phase 1

DESCRIPTION:
Doctors at City of Hope Medical Center seek participants for a trial of an investigatory treatment of recurrent/refractory myelomas testing positive for the CS1+ antigen. This treatment uses the patient’s own immune T-cells, gene-modifying them in the laboratory to impart a gene that helps them kill cancerous plasma cells. It will be delivered back to the patients in an autologous (to the self) transplant.

The trial will require leukapheresis to collect the immune cells from the bloodstream, then after they are gene-modified, chemotherapy will prepare the immune system for the self-transplant. The modified T-cells are re-infused and follow up will continue for 1 year and up to 15 years.


PATIENT MUST:

  • Be 18 years of age or older
  • Have a diagnosis of active MM as defined by the International Myeloma Working Group (IMWG) criteria, testing positive for CS1+ antigens.
    • Relapsed after or refractory to prior treatment with at least two regimens or lines of treatment
  • Be >= 90 days from undergoing any past autologous transplant at the time of enrollment

 


THE STUDY INVOLVES:

  1. Prescreening tests to confirm eligibility of the patient to participate.
  2. Have blood drawn, immune cells separated and blood cells returned (leukapheresis)
  3. After lab modification time, the patient will be admitted to the hospital and receive chemotherapy over 3 to 5 days.
  4. A few days later, the gene-edited immune cells will be infused.
  5. Recovery in the hospital.
  6. A second infusion at 28 day is possible.
  7. After completion of study treatment, patients are followed closely for 1 year and then yearly for 15 years.

LOCATIONS AND CONTACTS:
The study site is at the City of Hope Medical Center in Duarte, California. Map.

Contact:
Myo Htut, MD  |  626-218-2405  |  [email protected]
 
SPONSORS
City of Hope Medical Center
National Cancer Institute (NCI)
 
Or go online:
https://clinicaltrials.gov/ct2/show/NCT03710421

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