OncoMatch/Clinical Trials/NCT05858814
RC1012 Injection (Allo-DNT Cells) for the Prevention of Relapse in AML Patients After Allo-HSCT
Is NCT05858814 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies RC1012 for acute myeloid leukemia.
Treatment: RC1012 — To evaluate the safety and tolerability of RC1012 injection infusion in AML Patients after Allo-HSCT
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: allogeneic hematopoietic stem cell transplant
The subject has received an allogeneic HSCT within 60-100 days
Cannot have received: organ transplant
Exception: except for HSCT
Persons who have previously received an organ transplant or are preparing to receive an organ transplant (except for HSCT).
Cannot have received: maintenance therapy after HSCT
Subject who has received other maintenance therapy drugs after HSCT or who wish to receive other maintenance therapy.
Lab requirements
Blood counts
hemoglobin ≥ 80 g/L or maintained by transfusion; ANC ≥ 1.5 x 10^9/L; platelet count ≥ 50 x 10^9/L or maintained by transfusion; INR ≤ 1.5x ULN; APTT ≤ 1.5x ULN
Kidney function
serum creatinine ≤ 1.5x ULN or creatinine clearance ≥ 60 ml/min
Liver function
AST ≤ 3x ULN; ALT ≤ 3x ULN; total bilirubin ≤ 1.5x ULN (≤ 3.0x ULN for Gilbert-Meulengracht syndrome, direct bilirubin ≤ 1.5x ULN)
Cardiac function
LVEF ≥ 45%
With appropriate organ function: AST ≤ 3x ULN; ALT ≤ 3x ULN; total bilirubin ≤ 1.5x ULN, unless the patient has documented Gilbert syndrome. Patients with Gilbert-Meulengracht syndrome with total bilirubin ≤ 3.0x ULN and direct bilirubin ≤ 1.5x ULN may be included; serum creatinine ≤ 1.5x ULN or a creatinine clearance ≥ 60 ml/min; hemoglobin ≥ 80 g/L or hemoglobin maintained at that level following transfusion; INR ≤ 1.5x ULN and APTT ≤ 1.5x ULN; ANC ≥ 1.5 x 10^9/L; platelet count ≥ 50 x 10^9/L or maintained by transfusion; LVEF ≥ 45%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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