Clinical trial · Interventional
Clinical Study of CLL1 CAR-T Cells in the Treatment of Hematological Malignancies
Clinical Study on the Safety and Effectiveness of CLL1 CAR-T Cells in the Treatment of CLL1-positive Hematological Malignancies
NCT05252572CI-TRIAL-00056677unknownEarly 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 CLL1 CAR-T Cells in the Treatment of CLL1-positive 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 |
|---|---|---|---|
| AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CLL1 CAR T-cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment of CLL1-positive Hematological Malignancies
- description
- Administration of CLL1 CAR T-cells A dose levels of 2-8\*10E6/kg are administrated for each subject.
- interventionNames
- Biological: CLL1 CAR T-cells
Primary outcomes (2)
- measure
- Dose-limiting toxicity (DLT)
- timeFrame
- Baseline up to 28 days after CLL1 CAR T-cells infusion
- description
- Adverse events assessed according to NCI-CTCAE v5.0 criteria
- measure
- Incidence of treatment-emergent adverse events (TEAEs)
- timeFrame
- Up to 90 days after CLL1 CAR T-cells infusion
- description
- Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria:
* 1\. Patients is histologically diagnosed with CLL1-positive AML according to the NCCN Clinical Practice Guidelines in Oncology:Acute Myeloid Leukemia(Version 2.2021) 2. The diagnosis is consistent with r/r CLL1 + AML, and includes any of the following conditions:
1. No CR was obtained after 2 courses of standard chemotherapy
2. The first induction was CR, but the duration of CR was less than 12 months
3. No CR was obtained after the first or multiple remedial treatment;
4. Relapse twice or more; 3. The number of blast cells in bone marrow was more than 5% (morphology) and / or \> 1% (flow cytometry).
4\. No active lung infection, inhaled air oxygen saturation ≥92% 5. The estimated survival time is more than 3 months 6. ECOG score was 0-2 7. The patients or their legal guardians voluntarily participated in the trial and signed the informed consent.
Exclusion Criteria:
* 1\. Patients with history of epilepsy or other central nervous system diseases; 2. Patients with prolonged QT or severe heart disease; 3. Pregnant or lactating women (the safety of this therapy for unborn children is unknown); 4. The patients with uncontrolled active infection; 5. Active hepatitis B or hepatitis C virus infection; 6. Previous application of gene therapy; 7. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal; 8. Serum creatinine \> 2.5mg/dl or ALT / AST \> 3 times ULN or bilirubin \> 2.0mg/dl; 9. Those who suffer from other uncontrolled diseases are not suitable to join the study; 10. HIV infection; 11. Any situation that the researchers believe may increase the risk of patients or interfere with the test results.References
Publications (0)
Data not yet available
No reference posted for this study.