Clinical trial · Interventional
A Trial to Evaluate the Safety and Efficacy of NCR300 in Preventing Recurrence of Acute Myeloid Leukemia(AML) After Transplantation
A Phase I or II Clinical Trial Evaluating the Safety and Efficacy of NCR300 Injection in Preventing Recurrence of Acute Myeloid Leukemia After Allogeneic Blood Stem Cell Transplantation
NCT06441084CI-TRIAL-00077698not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A Trial to Evaluate the Safety and Efficacy of iNK in the Treatment of Subjects for Preventing Recurrence of Acute Myeloid Leukemia After Allogeneic Blood Stem Cell Transplantation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NCR300 injection | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NCR300 injection
- description
- Cohort1: Low dose NCR300 injection; Cohort2: Mid-low dose NCR300 injection; Cohort3: Mid-high dose NCR300 injection; Cohort4: High dose NCR300 injection.
- interventionNames
- Biological: NCR300 injection
Primary outcomes (2)
- measure
- Dose-Limiting Toxicity(DLT)
- timeFrame
- 4 weeks after initial infusion
- description
- Number of participants with Dose-limiting toxicity in 28 days after first infusion
- measure
- Adverse Event(AE) or Serious Adverse Event(SAE)
- timeFrame
- From the date of initial infusion to a year after initial infusion
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1.Subjects who understand and voluntarily sign the Informed Consent Form(ICF); 2.18-65years; 3.Clinical diagnosis of AML; 4.Accepted allogeneic blood stem cell transplantation within 60 to 28 days prior before initial infusion; 5.Complete donor chimerism and with high-risk recurrence factors prior to transplantation , or bone marrow examination shows positive MRD; 6.Have already recovered from the adverse reactions of previous treatment; 7.Having appropriate organ functions; 8.Eastern Cooperative Oncology Group(ECOG)\<3; 9.Subjects who are able to comply with contraceptives from the study period to 6 months after the end of this study; Exclusion Criteria: 1. Bone marrow examination shows hematological recurrence; 2. Have malignant tumors within 5 years before screening; 3. Subjects with acute promyelocytic leukemia(APL); 4. Subjects with severe respiratory diseases; 5. Subjects with clear history of neurological or psychiatric disorders in the past; 6. Active central nervous system involvement; 7. HIV(human immunodeficiency virus) antibody positive,treponema pallidum(TP) antibody positive.Have active hepatitis B or hepatitis C; 8. Allergies to NCR300 or its excipients; 9. Subjects with active cardiovascular and cerebrovascular diseases; 10. Received organ transplantation or planned transplantation; 11. Received other treatment drugs after transplantation; 12. Graft-Versus-Host Disease (GVHD)\>II grades; 13. Subjects with active nervous system autoimmune or inflammatory diseases; 14. Expected survival period within 3 months; 15. Have alcohol or drug addiction or with a clear history of mental disorders or with a history of drug abuse or drug use of psychotropic substances; 16. Having mental illness; 17. Having uncontrollable active infections; 18. Subjects whose state is not suitable for entering the study; 19. Other situations determined by investigator that it is not suitable to enter the study.
References
Publications (0)
Data not yet available
No reference posted for this study.