OncoMatch/Clinical Trials/NCT07369895
Clinical Study of O&D-001 Injection in the Treatment of Relapsed or Refractory Multiple Myeloma
Is NCT07369895 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Chimeric antigen receptor T cell O&D-001 for relapsed or refractory multiple myeloma.
Treatment: Chimeric antigen receptor T cell O&D-001 — This study is a single-center, open and dose-escalation clinical study to evaluate the safety, tolerability, PK/PD characteristics and preliminary efficacy of the investigational drug O\&D-001 injection in the treatment of relapsed or refractory multiple myeloma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Biomarker criteria
Required: BCMA (TNFRSF17) expression on myeloma cell membrane
Tumor specimen (bone marrow) from the subject tests positive for BCMA or GPRC5D expression on the myeloma cell membrane via immunohistochemistry (IHC) or flow cytometry.
Required: GPRC5D expression on myeloma cell membrane
Tumor specimen (bone marrow) from the subject tests positive for BCMA or GPRC5D expression on the myeloma cell membrane via immunohistochemistry (IHC) or flow cytometry.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: proteasome inhibitor
including failure of at least one proteasome inhibitor
Must have received: immunomodulatory agent
including failure of at least one...immunomodulatory agent
Cannot have received: CAR-T cell therapy
Prior treatment with CAR-T/TCR-T/TIL or other cell therapies
Cannot have received: TCR-T cell therapy
Prior treatment with CAR-T/TCR-T/TIL or other cell therapies
Cannot have received: tumor-infiltrating lymphocyte therapy
Prior treatment with CAR-T/TCR-T/TIL or other cell therapies
Cannot have received: allogeneic organ transplantation
known history of allogeneic organ transplantation
Cannot have received: allogeneic hematopoietic stem cell transplantation
known history of...allogeneic hematopoietic stem cell transplantation
Cannot have received: autologous stem cell transplantation
Exception: within 12 weeks prior to apheresis
Received autologous stem cell transplantation within 12 weeks prior to apheresis
Lab requirements
Blood counts
Hemoglobin ≥8.0 g/dL (no RBC transfusion within 7 days prior to laboratory testing; use of recombinant human erythropoietin is allowed); Platelets ≥50×10⁹/L (no platelet transfusion within 7 days prior to laboratory testing); ANC ≥1.0×10⁹/L (no growth factor support within 7 days prior to laboratory testing)
Kidney function
Creatinine Clearance ≥40 mL/min (Cockcroft-Gault formula)
Liver function
AST and ALT ≤3.0 × ULN; Total Bilirubin ≤1.5 × ULN
Cardiac function
Left Ventricular Ejection Fraction (LVEF) ≥50%
Major organ function is normal, defined as meeting the following criteria: Hemoglobin ≥8.0 g/dL... Platelets ≥50×10⁹/L... ANC ≥1.0×10⁹/L... AST and ALT ≤3.0 × ULN... Creatinine Clearance ≥40 mL/min... Total Bilirubin ≤1.5 × ULN... Corrected Serum Calcium ≤12.5 mg/dL... Fibrinogen ≥1.0 g/L... aPTT ≤1.5×ULN... PT ≤1.5 × ULN... Oxygen Saturation ≥92%... LVEF ≥50%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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