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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 (Jun 2026). This Phase 1/2 trial studies RC1012 for acute myeloid leukemia.

Phase 1/2RecruitingGuangdong Ruishun Biotech Co., LtdNCT05858814Data as of Jun 2026Location: China

Treatment: RC1012To evaluate the safety and tolerability of RC1012 injection infusion in AML Patients after Allo-HSCT

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Extracted eligibility criteria

Treatments studied

Other

RC1012

Cancer type

Acute Myeloid Leukemia

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 70

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.

Frequently asked questions

Is NCT05858814 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior organ transplant, maintenance therapy after HSCT disqualifies patients from enrollment.

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.

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