NCT04264078

Anti-CD7 U-CAR-T Cell Therapy for T/NK Cell Hematologic Malignancies

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Xinqiao Hospital of Chongqing · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• T-cell Leukemia
• T-cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	CD7 UCAR-T cells	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
DRUG	Fludarabine	30mg/m\^2 per day for 6 days
DRUG	Cytoxan	600mg/m\^2 per day for 2 to 6 days determined by tumor burden at baseline
DRUG	Melphalan	50 to 70 mg/m\^2 in total for 1 or 2 days, whether to use determined by tumor burden at baseline

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-06-01
• Completion: 2023-06-01
• First posted: 2020-02-11
• Last updated: 2021-06-28

Locations

1 site across 1 country: China