RecruitingPhase 1NCT07106749

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.

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

12 participants

Start Date

Jun 28, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia B Acute Lymphoblastic Leukemia/Lymphoma

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing CD180-targeting CAR-T cell therapy — a treatment where a patient's immune cells are engineered to recognize and attack cancer cells — for people with relapsed or refractory blood cancers that express the CD180 protein, including certain types of leukemia and lymphoma. **You may be eligible if:** - You are between 18 and 70 years old - You have been diagnosed with B-cell acute lymphoblastic leukemia, B-cell lymphoma, or acute myeloid leukemia - Your cancer cells test positive for the CD180 protein - Your cancer has come back or stopped responding to prior treatments - At least 5% of your bone marrow cells are cancer cells (blasts) **You may NOT be eligible if:** - Your cancer cells do not express CD180 - You have not had prior treatment (this is for relapsed/refractory disease) - You have serious organ problems that would make treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCD180 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

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NCT07106749

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