OncoMatch/Clinical Trials/NCT06999031
A Study to Evaluate CG-105-12 in Patients With Relapsed/Refractory Multiple Myeloma
Is NCT06999031 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies BCMA-Targeted Chimeric Antigen Receptor Autologous T-cell for relapsed/refractory.
Treatment: BCMA-Targeted Chimeric Antigen Receptor Autologous T-cell — This study is a single-centre, single-arm, open-label, dose-escalation exploratory study with single-dose administration. Its objective is to evaluate the safety, tolerability, dose, anti-tumor efficacy, and pharmacokinetic characteristics of CG-105-12 in the participants with BCMA-positive relapsed/refractory multiple myeloma who previously received adequate but uneffective standard treatments.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Biomarker criteria
Required: BCMA (TNFRSF17) overexpression (positive for BCMA expression on the membrane surface of plasma cells by IHC or flow cytometry)
Subjects whose tumor specimens were positive for BCMA expression on the membrane surface of plasma cells by immunohistochemistry (IHC) or flow cytometry
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: proteasome inhibitor
received at least 3 lines of therapy, including at least proteasome inhibitors (PIs) and immunomodulatory therapy (IMiD)
Must have received: immunomodulatory therapy
received at least 3 lines of therapy, including at least proteasome inhibitors (PIs) and immunomodulatory therapy (IMiD)
Cannot have received: BCMA CAR-T cell therapy
had not received prior BCMA CAR-T therapy
Cannot have received: monoclonal antibody
Exception: within 8 weeks prior to single nucleated cell collection
Treatment of multiple myeloma with monoclonal antibodies, CNS radiotherapy within 8 weeks prior to single nucleated cell collection
Cannot have received: CNS radiotherapy
Exception: within 8 weeks prior to single nucleated cell collection
Treatment of multiple myeloma with monoclonal antibodies, CNS radiotherapy within 8 weeks prior to single nucleated cell collection
Cannot have received: cytotoxic chemotherapy
Exception: within 14 days prior to single nucleated cell collection
cytotoxic chemotherapy, immunomodulator therapy, or proteasome inhibitor therapy within 14 days prior to single nucleated cell collection
Cannot have received: immunomodulatory therapy
Exception: within 14 days prior to single nucleated cell collection
cytotoxic chemotherapy, immunomodulator therapy, or proteasome inhibitor therapy within 14 days prior to single nucleated cell collection
Cannot have received: proteasome inhibitor
Exception: within 14 days prior to single nucleated cell collection
cytotoxic chemotherapy, immunomodulator therapy, or proteasome inhibitor therapy within 14 days prior to single nucleated cell collection
Cannot have received: granulocyte-macrophage colony-stimulating factor (GM-CSF, long-acting G-CSF)
Exception: within 14 days prior to the single nucleated cell collection
have received granulocyte-macrophage colony-stimulating factor (GM-CSF), long-acting granulocyte colony-stimulating factor (G-CSF) within 14 days prior to the single nucleated cell collection
Cannot have received: corticosteroid (prednisone or equivalent >20 mg/day)
Exception: within 7 days prior to screening
used therapeutic doses of corticosteroids (defined as prednisone or equivalent >20 mg/day) within 7 days prior to screening, but physiologic replacement, topical and inhaled steroids are permitted
Cannot have received: bendamustine (bendamustine)
Exception: within 12 weeks prior to screening
have received treatment containing bendamustine or fludarabine within 12 weeks prior to screening
Cannot have received: fludarabine (fludarabine)
Exception: within 12 weeks prior to screening
have received treatment containing bendamustine or fludarabine within 12 weeks prior to screening
Cannot have received: allogeneic hematopoietic stem cell transplantation
patients with previous allogeneic hematopoietic stem cell transplantation
Lab requirements
Blood counts
ANC ≥1E9/L; ALC ≥0.5E9/L; platelets >50E9/L; hemoglobin >60g/L or hematocrit >0.24
Kidney function
creatinine clearance (Cockcroft-Gault) GFR ≥40 ml/min (except for those whose renal function is abnormal due to progression of the primary disease as judged by the investigator)
Liver function
ALT and AST <2.5x ULN; serum total bilirubin <1.5x ULN
Cardiac function
LVEF ≥50%
Subjects must have adequate organ function and meet all of the following laboratory test results prior to enrollment: Complete blood count: Neutrophil count (ANC) 1E9/L; Lymphocyte count (ALC) 0.5E9/L; Platelet count >50E9/L; Haemoglobin >60g/L or Haematocrit >0.24; Liver function: ALT and AST <2.5x ULN; serum total bilirubin <1.5x ULN; Renal function: The creatinine clearance rate calculated according to the Cockcroft-Gault formula is GFR 40ml/min (except for those whose renal function is abnormal due to progression of the primary disease as judged by the investigator); Coagulation function: fibrinogen ≥ 1.0 g/L; aPTT ≤1.5×ULN, PT ≤ 1.5×ULN; Blood oxygen saturation > 91%; Left ventricular ejection fraction (LVEF) ≥ 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify