Actively Recruiting
CD180 CART for Relapsed or Refractory CD180 Positive Hematologic Malignancies
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-06
12
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CD180 CART for Relapsed or Refractory CD180 Positive Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to less than 70 years, any gender
- Diagnosis of B-ALL/LBL according to NCCN guidelines or AML according to Chinese guidelines
- Tumor cells confirmed positive for CD180
- Bone marrow blasts at least 5% at screening
- Relapsed or refractory AML or B-ALL/LBL meeting specified criteria including primary refractory status, relapse after remission, or relapse after transplantation
- Other relapsed/refractory CD180 positive hematologic malignancies
- Creatinine clearance over 60 ml/min
- Serum total bilirubin no more than 3 times upper normal limit; serum ALT and AST no more than 5 times upper normal limit if no liver invasion
- Left ventricular ejection fraction 50% or higher
- Oxygen saturation 92% or higher
- Estimated survival longer than 3 months
- ECOG performance status 0 to 2
- Voluntary participation with signed informed consent
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia (APL)
- Presence of genetic syndromes causing bone marrow failure such as Fanconi's anemia or Kostmann's syndrome
- Active uncontrolled central nervous system leukemia (CNS grades 2 or 3)
- Recent anti-tumor therapies: systemic chemotherapy within 1 week, monoclonal antibody treatment less than 4 weeks or 5 half-lives before screening, donor lymphocyte infusion within 6 weeks
- Uncontrolled serious infections at screening
- Serious heart conditions including severe insufficiency (NYHA class III or IV), recent myocardial infarction, unstable angina, significant ECG abnormalities
- Recent serious brain injury or neurological conditions requiring treatment within 6 months
- Positive for hepatitis B surface antigen above 10E6 IU/mL, hepatitis C, HIV, syphilis, or active EBV infection at screening
- Need for systemic steroid therapy during CAR-T infusion or long-term systemic steroids before treatment
- Autoimmune disease requiring treatment or immunodeficiency
- Recent acute or moderate-to-severe chronic graft-versus-host disease within 4 weeks
- History of allergy to cell product components
- Pregnant or breastfeeding women, or those not using effective contraception during and one year after treatment
- Any condition increasing risk or interfering with study results as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
J
Jianxiang Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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