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RECRUITING
NCT07106749
PHASE1

CD180 CART for Relapsed or Refractory CD180 Positive Hematologic Malignancies

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

Summary

The objective of this study was to evaluate the safety and efficacy of CD180 CART cells in the treatment of patients with relapsed/refractory CD180-positive hematological malignancies. In this single-arm, open-label, single-center, Phase I clinical trial, two cohorts were set up: (1) relapsed and refractory AML cohort; and (2) relapsed and refractory B-ALL/LBL cohort. CD180 CART cells will be administered intravenously using a 3+3 dose escalation and rapid titration design, with CART dose groups of (1) 0.5×10\^6 CART cells/kg;(2)1×10\^6 CART cells/kg; and (3) 3×10\^6 CART cells/kg. Each cohort was planned to enroll 6-12 patients.

Official title: CD180 CART Cell Injection in the Treatment of Relapsed or Refractory CD180 Positive Hematologic Malignancies: a Prospective, Single-arm, Single-center Clinical Study.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2025-06-28

Completion Date

2030-06-28

Last Updated

2025-08-06

Healthy Volunteers

No

Interventions

BIOLOGICAL

CD180 CART

Subjects screened to meet the requirements for CD180 CART use will enter clinical trials. Subjects were assessed at baseline. Fludarabine and cyclophosphamide based preconditioning should be performed within 1 week prior to CD180 CART infusion: fludarabine (Flu) 30mg/m2 ×3 days; cyclophosphamide (CTX) 500mg/m2 ×3 days. The investigator can adjust the pretreatment regimen appropriately according to the condition of the subject, such as increasing the dose of CTX to 600mg/m2 ×3 days, increasing the application of cytarabine and VP-16. Infusion of CD180 CART must be performed 24 hours after completion of chemotherapy preconditioning. CD180 CART can be infused at D-1 if the requirement of 24 hours after completion of preconditioning is met.

Locations (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China