OncoMatch/Clinical Trials/NCT06464991
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Is NCT06464991 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for multiple myeloma.
Treatment: Equecabtagene Autoleucel · Daratumumab · Pomalidomide · Bortezomib · Dexamethasone — This is a multicenter, randomized, controlled, open-label, phase III clinical study to evaluate the efficacy of Equecabtagene Autoleucel Injection versus standard therapy in subjects with lenalidomid-refractory RRMM who have received 1-2 lines of prior therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: proteasome inhibitor
including chemotherapy regimens based on proteasome inhibitors
Must have received: immunomodulatory agent
including chemotherapy regimens based on...immunomodulatory agents
Must have received: lenalidomide (lenalidomide)
Subjects was lenalidomide-refractory during prior therapy
Cannot have received: autologous hematopoietic stem cell transplantation
Exception: within 12 weeks prior to randomization
Subjects who have undergone autologous haematopoietic stem cell transplantation (Auto-HSCT) within 12 weeks prior to randomization
Cannot have received: allogeneic hematopoietic stem cell transplantation
previously undergone allogeneic haematopoietic stem cell transplantation (Allo-HSCT)
Cannot have received: immunomodulator
Exception: within 7 days prior to enrollment
Treated with an immunomodulator within 7 days
Cannot have received: plasma exchange
Exception: within 14 days prior to enrollment
Received plasma exchange...within 14 days
Cannot have received: radiotherapy
Exception: within 14 days prior to enrollment (except local radiotherapy for myeloma-related bone lesions)
radiotherapy (except local radiotherapy for myeloma-related bone lesions)...within 14 days
Cannot have received: cytotoxic chemotherapy
Exception: within 14 days prior to enrollment
cytotoxic chemotherapy...within 14 days
Cannot have received: proteasome inhibitor
Exception: within 14 days prior to enrollment
treatment with proteasome inhibitors...within 14 days
Cannot have received: investigational drug
Exception: within 14 days prior to enrollment
other investigational drug within 14 days
Cannot have received: monoclonal antibody for multiple myeloma
Exception: within 21 days prior to enrollment
Treatment with monoclonal antibody for multiple myeloma within 21 days
Cannot have received: other anti-cancer therapy
Exception: within 14 days or at least 5 half-lives (whichever is shorter) prior to enrollment
Received other anti-cancer therapy within 14 days or at least 5 half-lives (whichever is shorter) prior to enrollment
Lab requirements
Blood counts
ANC ≥1×10^9/L (no growth factor within 7 days); ALC ≥0.3×10^9/L; Platelets ≥50×10^9/L (no platelet transfusion within 7 days); Hemoglobin ≥60g/L (no RBC transfusion within 7 days)
Kidney function
creatinine clearance (CrCl) ≥ 40 ml/min
Liver function
ALT and AST ≤2.5x ULN; total bilirubin ≤1.5x ULN
Cardiac function
LVEF ≥50%
Subjects must have appropriate organ function and meet all of the following laboratory test results before enrollment: (1) Haematology: absolute neutrophil count (ANC) ≥1×10^9/L (support with growth factor is allowed, but must not have received supportive treatment within 7 days before the laboratory test); Absolute lymphocyte count (ALC) ≥0.3×10^9/L; Platelets ≥50×10^9 / L (must not have received platelet transfusion within 7 days prior to laboratory test); Hemoglobin ≥60g/L (must not have received red blood cells transfusion within 7 days prior to laboratory test); (2) Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times of upper limit of normal (ULN); Serum total bilirubin ≤1.5 times of ULN; (3) Renal function: creatinine clearance (CrCl) calculated by Cockcroft-Gault formula ≥ 40 ml/min; (4) Coagulation: fibrinogen≥1.0 g/L; activated partial thromboplastin time (APTT) ≤ 1.5×ULN, pro-thrombin time (PT) ≤ 1.5 × ULN; (5) Pulse oxygen saturation > 91%; (6) Left ventricular ejection fraction (LVEF)≥50%;
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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