At a glance
ClinicalIndex Comparison Record- ✓Diagnosed with AML according to WHO 2016 criteria
- ✓Allogeneic HSCT within 60-100 days with <5% malignant cells and complete donor chimerism
- ✓High-risk factors for relapse including: failure to achieve remission after 2 induction courses, prior MDS/MPN, high leukocytes ≥100×10^9/L with CNSL, positive MRD before HSCT, non-remission/progression before HSCT, or cytogenetic high-risk factors
- ✓Age 18-70 years inclusive
- ✕Morphological relapse of leukemia or positive MRD after allo-HSCT
- ✕Extramedullary infiltration of leukemia
- ✕Other malignancies within 5 years prior to screening (except adequately treated carcinoma in situ cervix, basal/squamous cell skin cancer, post-radical thyroid cancer, post-radical DCIS)
- ✕Severe respiratory disease (interstitial lung disease, COPD, pulmonary insufficiency, symptomatic bronchospasm)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05858814Phase 2RecruitingUpdate OverdueUpdated 37mo ago · Completion was 25mo agoA Phase I/II Clinical Trial of RC1012 Injection for the Prevention of Relapse in AML Patients After Allogeneic Hematopoietic Stem Cell Transplantation
In Brief
A Phase 2 clinical trial evaluating RC1012 injection (allo-DNT cells) for Acute Myeloid Leukemia. Currently recruiting, targeting 72 participants across 1 site.
Signals
Detailed Summary
To evaluate the safety and tolerability of RC1012 injection infusion in AML Patients after Allo-HSCT
Study Details
Timeline
Interventions
RC1012 injection (allo-DNT cells) are from healthy donors and have been proved to be safe and demonstrated potent cytotoxicity against AML blasts from AML patients in preclinical and preliminary clinical studies. Allo- DNT cells will be collected from healthy donors (NO MHC match needed) and injected into patients. The drug for this study is an off-the-shelf product. Patients DO NOT need to wait for the cell manufacturing.