Clinical trial · Interventional
Humanized CD7 CAR T-cell Therapy for r/r CD7+ Acute Leukemia
Humanized Chimeric Antigen Receptor T Cells Against CD7 for Refractory/Relapsed CD7+ Acute Leukemia
NCT04762485CI-TRIAL-00052068unknownPhase 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)
This is a prospective,open-label, single center and single arm phase 1/2 study to evaluate the efficacy and safety of T cells expressing humanized CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive acute leukemia.
Conditions
Conditions (3)
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 |
| Mixed Phenotype Acute Leukemia | Mixed Phenotype Acute Leukemia | ONTOLOGY_EXACT | 0.98 |
| T Lymphoblastic Leukemia/Lymphoma | T Lymphoblastic Leukemia/Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Humanized CD7 CAR-T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD38 positive relapsed or refractory acute leukemia
- description
- Biological/Vaccine: Humanized CD7 CAR-T cells Split intravenous infusion of CD7 CAR-T cells \[dose escalating infusion of (0.5- 10)x10\^6 CD7 CAR-T cells/kg
- interventionNames
- Biological: Humanized CD7 CAR-T cells
Primary outcomes (1)
- measure
- Number of Adverse Events
- timeFrame
- 12 months
- description
- Adverse events are evaluated with CTCAE V5.0
Secondary outcomes (3)
- measure
- Overall response rate (ORR)
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosed CD7 positive relapsed/refractory acute leukemia. 2. Age 12-65 years. 3. Eastern Cooperative Oncology Group (ECOG) score 0-2. 4. CD7 on leukemia is \>30% positive detected with flow cytometry. 5. Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification. 6. Patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dL. Exclusion Criteria: 1. Patients are pregnant or lactating 2. Patients with congenital immunodeficiency. 3. Patients with central nervous system leukemia. 4. Patients with uncontrolled active infection. 5. Patients with active hepatitis B or hepatitis C infection. 6. Patients with HIV infection. 7. Patients with atrial or venous thrombosis or embolism. 8. Patients with myo-infarction or severe arrythmia in the recent 6 months. 9. Other comorbidities that investigators considered not suitable for this study.
References
Publications (1)
- DERIVEDCao X, Dai H, Cui Q, Li Z, Shen W, Pan J, Shen H, Ma Q, Li M, Chen S, Chen J, Zhu X, Meng H, Yang L, Wu D, Tang X. CD7-directed CAR T-cell therapy: a potential immunotherapy strategy for relapsed/refractory acute myeloid leukemia. Exp Hematol Oncol. 2022 Sep 29;11(1):67. doi: 10.1186/s40164-022-00318-6. PMID 36175988