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
N/A
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
Researchers are investigating the safety and early effectiveness of a special treatment called CLL1 and CD38 dual-target CAR T cell injection for adults with relapsed or refractory acute myeloid leukemia (AML). This phase I, open-label, dose-escalation study focuses on patients whose leukemia has returned or not responded to previous treatments. The trial aims to understand how well this dual-target CAR-T therapy works and its possible risks. The study involves a single treatment arm where participants receive the CAR T cell injection modified to target both CLL1 and CD38 proteins found on leukemia cells. The trial includes two phases: the first uses an accelerated titration design to find a safe dose, and the second follows a 3+3 design to further evaluate dosing. Participants may undergo allogeneic hematopoietic stem cell transplantation after receiving the CAR-T cells if needed. During the study, participants will be closely monitored for dose-limiting toxicities within the first 28 days and tracked for adverse events over 96 weeks. Researchers will assess various outcomes including remission rates, survival, and cell behavior in the body. Participants will undergo regular tests and evaluations according to the study protocol, with follow-up visits scheduled for up to nearly two years after treatment to measure long-term safety and response.
CONDITIONS
Brief 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 old at the time of consent
- Diagnosed with relapsed or refractory acute myeloid leukemia (excluding acute promyelocytic leukemia) based on 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 ejection fraction, and oxygen saturation
- Ability to stop corticosteroids from day 7 until 30 days after CAR T cell infusion
- Negative pregnancy test for women of childbearing potential; agreement on contraception for men and women for 2 years after infusion
- Willingness to follow study protocol and sign informed consent
You will not qualify if you...
- Allergy to any study drug ingredients
- Recent use of high-dose corticosteroids or other immunosuppressive drugs around study treatment
- Systemic anti-tumor therapy within 14 days before apheresis
- Radiotherapy within 4 weeks before apheresis
- Donor lymphocyte infusion within 6 weeks before apheresis
- Diagnosis of acute promyelocytic leukemia
- Previous CAR-T, CAR-NK, or other genetically modified cell therapy
- Allogeneic stem cell transplantation within 6 months before screening
- Active graft-versus-host disease or need for immunosuppressive drugs
- Active infection requiring systemic treatment
- History of active malignancy within 5 years except certain low-risk cancers
- Stroke or seizure within 6 months before consent
- Significant heart diseases including severe heart failure, recent heart attack, severe arrhythmias, or uncontrolled hypertension
- Central nervous system involvement with leukemia
- Positive tests for HIV, hepatitis B or C, or syphilis
- Pulmonary fibrosis
- Active autoimmune diseases
- Recent live attenuated vaccine within 4 weeks before screening
- Major surgery within 4 weeks before apheresis or planned during study except biopsy
- Pregnancy, breastfeeding without agreement to stop, or plans for children during or 2 years after study treatment
- Unresolved side effects from previous treatments above grade 1 except certain stable conditions
- Any condition judged by the investigator to interfere with participation or study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days
Participants receive CLL1 and CD38 dual-target CAR-T cell injection to treat relapsed or refractory acute myeloid leukemia.
1 treatment visit and multiple monitoring visits during the first 28 days
Duration - Up to 96 weeks
Participants are monitored for safety and efficacy outcomes after treatment.
Regular visits during follow-up for up to 96 weeks
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital, China
Tianjin, China
Actively Recruiting
Research Team
Y
Ying Wang
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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