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OncoMatch/Clinical Trials/NCT03710421

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

Is NCT03710421 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Cyclophosphamide and Fludarabine for recurrent plasma cell myeloma.

Phase 1RecruitingCity of Hope Medical CenterNCT03710421Data as of May 2026

Treatment: Cyclophosphamide · FludarabineThis 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.

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Extracted eligibility criteria

Cancer type

Multiple Myeloma

Biomarker criteria

Required: SLAMF7 overexpression (CS1+)

confirmed CS1+ MM as evaluated by City of Hope (COH) Pathology Core

Prior therapy

Min 3 prior lines

Must have received: immunomodulatory agent

Must have received: proteasome inhibitor

Must have received: anti-cd38 antibody

Cannot have received: allogeneic stem cell transplantation

Lab requirements

Blood counts

Absolute neutrophil count >= 1000/uL (no transfusions/growth factors at screening); Hemoglobin >= 8 g/dl (no transfusions/growth factors at screening); Platelet count >= 50,000/uL (>= 30,000/uL if bone marrow plasma cells >= 50% of cellularity; no transfusions/growth factors at screening)

Kidney function

Serum creatinine <= 2.5 x ULN or estimated creatinine clearance >= 40 mL/min per Cockcroft-Gault formula, not on hemodialysis

Liver function

Total serum bilirubin <= 2.0 mg/dL (<= 3.0 mg/dL if Gilbert syndrome); AST < 2.5 x ULN; ALT < 2.5 x ULN

Cardiac function

Left ventricular ejection fraction >= 45% within 8 weeks before enrollment; O2 saturation >= 92%

Total serum bilirubin <= 2.0 mg/dL. Participants with Gilbert syndrome may be included if their total bilirubin is <= 3.0. AST < 2.5 x ULN. ALT < 2.5 x ULN. Serum creatinine <= 2.5 x ULN or estimated creatinine clearance of >= 40 mL/min per the Cockcroft-Gault formula, and the participant is not on hemodialysis. Absolute neutrophil count >= 1000/uL. Hemoglobin (Hb) >= 8 g/dl. Platelet count >= 50,000/uL (>= 30,000/uL if bone marrow plasma cells are >= 50% of cellularity). Left ventricular ejection fraction >= 45% within 8 weeks before enrollment. Oxygen (O2) saturation >= 92%.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • City of Hope Medical Center · Duarte, California

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