Clinical trial · Interventional
Multi-CAR T Cell Therapy for Acute Myeloid Leukemia
Multi-center Phase I/II Clinical Trial of Multi-CAR T Cell Therapy for Acute Myeloid Leukemia
NCT03222674CI-TRIAL-00123848not yet recruitingPhase 1 / Phase 2ClinicalTrials.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)
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of multi-CAR T cell therapy targeting different AML surface antigens in patients with relapsed or refractory acute myeloid leukemia (AML). Another goal of the study is to learn more about the function of the multi-CAR T cells and their persistency in the patients.
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 |
|---|---|---|---|
| Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm
- description
- CAR T cells to treat AML
- interventionNames
- Biological: Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells
Primary outcomes (1)
- measure
- percentage of patients with treatment related adverse effect
- timeFrame
- a year
- description
- percentage of participants with treatment-related adverse events, as assessed by physical exam, vital signs, standard clinical labs and so on.
Secondary outcomes (1)
- measure
- Anti tumor activity of fourth generation CAR-T cells in patients with relapsed or refractory AML
- timeFrame
- a year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age older than 2 years. 2. CD33, CD38, CD56, CD123, MucI, and CLL1 expression can be identified in the malignant cells by immuno-histochemical staining or flow cytometry. 3. Karnofsky performance status (KPS) score is higher than 80 and life expectancy \> 2 months. 4. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg/dL. 5. Hgb≥80g/L. 6. No cell separation contraindications. 7. Abilities to understand and the willingness to provide written informed consent. Exclusion Criteria: 1. Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection. 2. Active bacterial, fungal or viral infection not controlled by adequate treatment. 3. Known HIV or hepatitis B virus (HBV) infection. 4. Pregnant or nursing women may not participate. 5. History of glucocorticoid for systemic therapy within the week prior to entering the test. 6. Previously treatment with any gene therapy products. 7. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
References
Publications (1)
- DERIVEDPei K, Xu H, Wang P, Gan W, Hu Z, Su X, Zhang H, He Y. Anti-CLL1-based CAR T-cells with 4-1-BB or CD28/CD27 stimulatory domains in treating childhood refractory/relapsed acute myeloid leukemia. Cancer Med. 2023 Apr;12(8):9655-9661. doi: 10.1002/cam4.5916. Epub 2023 Apr 9. PMID 37031462