Actively Recruiting
A Clinical Study to Explore the Safety and Efficacy of CD33 CAR-T Cell in Relapsed/Refractory Acute Myeloid Leukemia
Led by Zhejiang University · Updated on 2025-01-07
27
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
Y
Yake Biotechnology Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of CD33 CAR-T cell therapy for patients with relapsed or refractory acute myeloid leukemia (AML). This early phase 1 trial involves a single-arm, open-label, dose-escalation design to evaluate this biological treatment targeting CD33 in patients whose leukemia has returned or not responded to previous treatments. The study aims to better understand how this therapy works in this challenging condition. Participants will receive CD33 CAR T-cells through intravenous infusion. The trial uses a standard 3+3 dose escalation method with three different dose levels to determine the optimal dose. The trial plans to enroll between 15 and 27 participants, all receiving the experimental CAR-T cell treatment during the study period. During the study, participants will be closely monitored for safety by tracking dose-limiting toxicities up to 28 days after treatment and recording any treatment-emergent adverse events for up to two years. Researchers will also assess treatment responses such as complete remission, duration of remission, overall survival, and leukemia-free survival over periods ranging from 12 weeks to two years. Participants can expect regular evaluations including clinical exams, laboratory tests, and follow-up visits throughout the study and beyond to measure these outcomes and ensure safety.
CONDITIONS
Brief Title
A Clinical Study to Explore the Safety and Efficacy of CD33 CAR-T Cell in Relapsed/Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, age 18 years or older
- Able to prepare CAR-T cells normally or previously failed autologous CAR-T cell preparation
- Diagnosed with CD33 positive acute myeloid leukemia with CD33 expression rate over 80%
- Meets 2016 WHO classification for AML and diagnostic criteria for relapsed or refractory AML
- Bone marrow primitive cell count over 5% by morphology or over 1% by flow cytometry
- Total bilirubin ≤ 51 μmol/L, ALT and AST ≤ 3 times upper normal limit, serum creatinine ≤ 176.8 μmol/L
- Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography
- No active lung infection; oxygen saturation on air ≥ 92%
- Estimated survival time over 3 months
- ECOG performance status score 0 to 2
- Willing to use effective contraception during study and for 6 months after last infusion
- Voluntary participation with informed consent
You will not qualify if you...
- History of epilepsy or other central nervous system diseases
- Prolonged QT interval or severe heart disease
- Untreated active infection
- Active hepatitis B or C infection
- Prior use of any gene therapy products
- Proliferation rate less than 5 times response to CD3/CD28 stimulation
- Other uncontrolled diseases deemed unsuitable by researchers
- HIV infection
- Any condition increasing risk or interfering with trial results as judged by researchers
AI-Screening
AI-Powered Screening
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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 after treatment
Participants receive CD33 CAR T-cell therapy by intravenous infusion with dose escalation across 3 dose levels following a standard 3+3 design.
1 infusion visit and multiple follow-up visits for up to 28 days
Duration - Up to 2 years after treatment
Participants are monitored for safety and efficacy outcomes including adverse events, remission status, and survival.
Regular visits up to 2 years after treatment
Trial Site Locations
Total: 1 location
1
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
H
He Huang, MD
Y
Yongxian Hu, MD
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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