RecruitingPhase 1NCT03710421

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


Sponsor

City of Hope Medical Center

Enrollment

30 participants

Start Date

Apr 23, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

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 (relapsed) or does not respond to treatment (refractory). 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. These engineered immune cells, CS1-CAR T cells, may kill multiple myeloma cells.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new cell therapy approach for multiple myeloma (a blood cancer of plasma cells) that has come back or stopped responding to treatment — using the patient's own immune T cells that are genetically engineered to find and destroy myeloma cells carrying a protein called CS1. **You may be eligible if...** - You have been diagnosed with active multiple myeloma - Your myeloma tests positive for the CS1 protein - Your myeloma has relapsed or is refractory (stopped responding) after at least 3 prior treatment regimens, including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody - You are generally in acceptable health (Karnofsky performance status at least 70%) - Your life expectancy is at least 16 weeks **You may NOT be eligible if...** - Your myeloma does not express the CS1 protein - You have not received the required prior treatments - You have had a prior autologous stem cell transplant within 90 days before enrollment - You have serious liver, heart, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURECS1-CAR T Therapy

Undergo CS1-CAR T therapy

DRUGCyclophosphamide

Given IV

DRUGFludarabine

Given IV

PROCEDURELeukapheresis

Undergo leukapheresis


Locations(1)

City of Hope Medical Center

Duarte, California, United States

View Full Details on ClinicalTrials.gov

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NCT03710421


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