NCT07106749

CD180 CART for Relapsed or Refractory CD180 Positive Hematologic Malignancies

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will utilize CD180 CART cells to treat CD180-positive relapsed or refractory hematological malignancies, especially AML and B-ALL/LBL patients. Two cohorts were established: (1) relapsed and refractory AML cohort; and (2) relapsed and refractory B-ALL/LBL cohort. A 3+3 dose escalation and rapid titration design was used to explore the maximum tolerated dose for each cohort. 3+3 dose escalation CART dose groups were (1) 0.5×10\^6 CART cells/kg; (2)1×10\^6 CART cells/kg;(3) 3×10\^6 CART cells/kg. A minimum of 6 and a maximum of 12 patients are expected to be enrolled in each cohort. Fludarabine and cyclophosphamide-based preconditioning should be performed within 1 week prior to CD180 CART infusion. CD180 CART can be infused on D-1 provided that the requirement of 24 hours after completion of preconditioning is met. The objective of the study was to evaluate the safety and efficacy of CD180 CART cells in the treatment of patients with relapsed/refractory CD180-positive hematological malignancies.

Conditions

• Acute Myeloid Leukemia
• B Acute Lymphoblastic Leukemia/Lymphoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-28
• Primary completion: 2028-06-28
• Completion: 2030-06-28
• First posted: 2025-08-06
• Last updated: 2025-08-06

Locations

1 site across 1 country: China