OncoMatch/Clinical Trials/NCT07109323
Autologous Transplantation Combined With BCMA CAR-T in the Treatment of UHR-MM
Is NCT07109323 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies BCMA CART for ultra high risk mm (uhr-mm), 18-70 years old, suitable for asct. and meet any of the following uhr-mm definitions.
Treatment: BCMA CART — To evaluate the safety and efficacy of autologous hematopoietic stem cell transplantation (ASCT) combined with BCMA-CART in the treatment of UHR-MM.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Biomarker criteria
Allowed: TP53 mutation
TP53 mutation
Allowed: TP53 deletion
p53 deletion
Allowed: TP53 del(17p)
del(17p)≥60%
Allowed: WHSC1 t(4;14)
t (4; 14)
Allowed: MAF t(14;16)
t (14; 16)
Allowed: MAFB t(14;20)
t (14; 20)
Allowed: MYC translocation
myc translocation (deletion or copy number abnormality: ≥ 20% is positive; translocation: ≥ 10% is positive)
Disease stage
Required: Stage R2-ISS-IV, MPSS-IV
6) R2-iss-iv /mpss-iv.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: autologous hematopoietic stem cell transplantation
History of autologous / allogeneic hematopoietic stem cell transplantation
Cannot have received: allogeneic hematopoietic stem cell transplantation
History of autologous / allogeneic hematopoietic stem cell transplantation
Cannot have received: CAR-T cell therapy
Have used any car-t cell products or other genetically modified T cell therapies
Cannot have received: BCMA targeted therapy
Received BCMA targeted therapy
Lab requirements
Blood counts
Hemoglobin (HB) ≥ 60g/L; ANC ≥ 1.0 × 10^9/L (no G-CSF within 7 days); ALC ≥ 0.5 × 10^9/L; Platelet (PLT) ≥ 50 × 10^9/L (no platelet transfusion within 7 days)
Kidney function
Creatinine clearance (CrCl) ≥ 40ml/min
Liver function
Serum total bilirubin (TBIL) ≤ 1.5x ULN; ALT and AST ≤ 2.5x ULN
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 45%; Blood oxygen saturation (SpO2) ≥ 92%
Serum total bilirubin (TBIL) ≤ 1.5x ULN; ALT and AST ≤ 2.5x ULN; Creatinine clearance (CrCl) ≥ 40ml/min; Prothrombin time (PT) ≤ 1.5x ULN, partial prothrombin time (APTT) < 1.5x ULN, INR < 1.5x ULN; Hemoglobin (HB) ≥ 60g/L; ANC ≥ 1.0 × 10^9/L (no G-CSF within 7 days); ALC ≥ 0.5 × 10^9/L; Platelet (PLT) ≥ 50 × 10^9/L (no platelet transfusion within 7 days); LVEF ≥ 45%; SpO2 ≥ 92%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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