OncoMatch/Clinical Trials/NCT07109323
Autologous Transplantation Combined With BCMA CAR-T in the Treatment of UHR-MM
Is NCT07109323 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
Cancer type
Multiple Myeloma
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)
Demographics
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.
Frequently asked questions
Is NCT07109323 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior autologous hematopoietic stem cell transplantation, allogeneic hematopoietic stem cell transplantation, CAR-T cell therapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage R2-ISS-IV or MPSS-IV is required.
Is there an age limit?
Yes. Patients must be 70 years or younger.
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 qualifyRelated pages