Actively Recruiting
A Clinical Study to Evaluate the Safety and Efficacy of CLL1 and CD38 Dual-Target CAR-T Cell Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-06-03
37
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
G
Gracell Biotechnologies (Shanghai) Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-arm, open-label, phase I dose-escalation clinical study to evaluate the safety and preliminary efficacy of CLL1 and CD38 dual-target CAR T cell injection in r/r AML subjects.
CONDITIONS
Official Title
A Clinical Study to Evaluate the Safety and Efficacy of CLL1 and CD38 Dual-Target CAR-T Cell Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years at the time of consent
- Diagnosed with relapsed or refractory acute myeloid leukemia (excluding acute promyelocytic leukemia) according to WHO 2022 and 2023 Chinese guidelines
- Positive expression of CLL1 and/or CD38 in tumor cells
- Estimated survival of at least 3 months
- Confirmed donor available for allogeneic hematopoietic stem cell transplantation
- ECOG performance status score of 0 to 2 during screening
- Adequate organ function including liver enzymes, bilirubin, kidney function, heart function, and oxygen saturation
- Ability to stop corticosteroids from day 7 and continue until 30 days after CAR T cell infusion
- Negative pregnancy test for women of childbearing potential; agreement to use effective contraception for men and partners
- Willingness to follow study protocol and sign informed consent
You will not qualify if you...
- Known allergy to any study drug ingredients
- Recent use of high-dose corticosteroids or immunosuppressive medications
- Systemic anti-tumor therapy within 14 days before apheresis or within five half-lives of the drug
- Radiotherapy within 4 weeks before apheresis
- Donor lymphocyte infusion within 6 weeks before apheresis
- Diagnosis of acute promyelocytic leukemia
- Prior CAR-T, CAR-NK, or other genetically modified cell therapies
- Allogeneic hematopoietic stem cell transplantation within 6 months before screening
- Active or recent graft-versus-host disease requiring immunosuppressive drugs
- Active infection requiring systemic treatment
- History of active malignancy within 5 years except certain cancers with no recurrence
- Stroke or seizure within 6 months prior to consent
- Serious heart conditions including severe heart failure, recent myocardial infarction, arrhythmias, cardiomyopathy, or uncontrolled hypertension
- Central nervous system involvement in AML
- Positive tests for HIV, hepatitis B or C, or syphilis
- Pulmonary fibrosis
- Active autoimmune diseases
- Live attenuated vaccine within 4 weeks prior to screening
- Major surgery within 4 weeks before apheresis or planned during the study
- Pregnancy or breastfeeding without agreement to stop breastfeeding; plans for children during study or two years after
- Unresolved acute side effects from previous treatments above grade 1
- Any condition judged by investigators to interfere with participation or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital, China
Tianjin, China
Actively Recruiting
Research Team
Y
Ying 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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