NCT04264078

Anti-CD7 Universal CAR-T Cells for CD7+ T/NK Cell Hematologic Malignancies: a Multi-center, Uncontrolled Trial

Study Summary

The prognosis of patients with relapsed and/or refractory T-cell hematologic malignancies is poor due to lacking sufficient treatment.Anti-CD(cluster of differentiation antigen)19 CAR(chimeric antigen receptor)-T cell therapies are efficient for patients with B-cell hematologic malignancies. As for T-cell hematologic malignancies, CD7 is a promising target expressed on most malignant T cells. The outcome of CD-7 CAR-T cell therapy pre-clinical experiments is cheerful.however, how to select the functional T cells from the malignant T cells is a challenge. In addition to this, auto-CAR-T cell therapy is not affordable for the majority of patients. Using T cells aphesis from healthy donors edited to avoid rejection of the host as the material of anti-CD7 universal CAR-T cells could be accessible and affordable, which is adapted for patients with CD7+ relapsed and/or refractory T/NK-cell hematologic malignancies.

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Interventions

CD7 UCAR-T cellsBIOLOGICAL
Dose range:1 to 5 ×10\^7 cells/Kg, Dose level one: 1×10\^7 cells/Kg, Dose level two: 3×10\^7 cells/Kg, Dose level three:5 ×10\^7 cells/Kg
FludarabineDRUG
30mg/m\^2 per day for 6 days
CytoxanDRUG
600mg/m\^2 per day for 2 to 6 days determined by tumor burden at baseline
MelphalanDRUG
50 to 70 mg/m\^2 in total for 1 or 2 days, whether to use determined by tumor burden at baseline

Study Locations

FacilityCityStateCountry
Department of Hematology, Xinqiao HospitalChongqingChongqing MunicipalityChina

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026