Clinical trial · Interventional
Clinical Study on the Safety and Effectiveness of NK Cells/Combined Monoclonal Antibodies in the Treatment of Hematological Malignancies
Clinical Trial for the Safety and Effectiveness of NK Cells/Combined Monoclonal Antibodies in the Treatment of Hematological Malignancies
NCT04662788CI-TRIAL-00048767not yet recruitingEarly Phase 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)
Clinical study on the safety and effectiveness of NK cells/combined monoclonal antibodies in the treatment of hematological malignancies
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 |
|---|---|---|---|
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NK cells/Combined Monoclonal Antibodies | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Administration of NK cells/Combined Monoclonal Antibodies
- interventionNames
- Drug: NK cells/Combined Monoclonal Antibodies
Primary outcomes (2)
- measure
- Dose-limiting toxicity (DLT)
- timeFrame
- Baseline up to 28 days after NK cells/Combined Monoclonal Antibodies infusion
- description
- Adverse events assessed according to NCI-CTCAE v5.0 criteria
- measure
- Incidence of treatment-emergent adverse events (TEAEs)
- timeFrame
- Up to 2 years after NK cells/Combined Monoclonal Antibodies infusion
- description
- Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed diagnosis of AML per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1); 2. Relapsed or refractory AML (meeting one of the following conditions): 1. CR not achieved after standardized chemotherapy; 2. CR achieved following the first induction, but CR duration is less than 12 months; 3. Ineffectively after first or multiple remedial treatments; 4. 2 or more relapses; 3. The number of primordial cells in bone marrow is \> 5% (by morphology), and/or \> 0.01% (by flowcytometry); 4. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L; 5. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%; 6. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%; 7. Estimated survival time ≥ 3 months; 8. ECOG performance status 0 to 2; 9. Patients or their legal guardians volunteer to participate in the studyand sign the informed consent. Exclusion Criteria: 1. History of craniocerebral trauma, conscious disturbance,epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagicdiseases; 2. Electrocardiogram shows prolonged QT interval, severe heart diseasessuch as severe arrhythmia in the past; 3. Pregnant (or lactating) women; 4. Patients with severe active infections (excluding simple urinarytractinfectionand bacterial pharyngitis); 5. Active infection of hepatitis B virus or hepatitis C virus; 6. Concurrent therapy with systemic steroids within 2 weeks prior toscreening, except for the patients recently or currently receiving in haledsteroids; 7. Previously treated with any CAR-T cell product or other genetically- modified T cell therapies; 8. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl; 9. Other uncontrolled diseases that were not suitable for this trial; 10. Patients with HIV infection; 11. Any situations that the investigator believes may increase the risk ofpatients or interfere with the results of study.
References
Publications (0)
Data not yet available
No reference posted for this study.