Actively Recruiting
CD7-specific CAR-T Cell in the Treatment of CD7-positive Relapsed/Refractory Hematologic Tumors
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2024-12-06
80
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
H
Hebei Taihe Chunyu Biotechnology Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a single-center, open, prospective single-arm clinical study of patients with CD7 postive relapsed / refractoryhematological tumors to evaluate the safety and efficacy of CD7-specific CAR-T cells in relapsed / refractory hematological tumors while collecting pharmacokinetics and pharmacodynamics indicators of CAR-T cells.
CONDITIONS
Official Title
CD7-specific CAR-T Cell in the Treatment of CD7-positive Relapsed/Refractory Hematologic Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsed or refractory hematologic malignancies with either early or late recurrence or failure to achieve remission after standard treatments
- Tumor cells confirmed to express CD7 by bone marrow flow cytometry or immunohistochemistry
- Peripheral blood tumor cells are CD4 and CD8 negative, or if not, must be less than or equal to 1% of peripheral blood tumor cells
- ECOG fitness score between 0 and 2
- Expected survival of more than 3 months
- Liver, kidney, and heart function meeting criteria: serum creatinine ≤ 1.5 times upper limit of normal (ULN); left ventricular ejection fraction ≥ 50%; peripheral oxygen saturation > 90%; total bilirubin ≤ 1.5 times ULN; ALT and AST ≤ 2.5 times ULN
- Patient or legal guardian consents voluntarily to participate and signs informed consent form
You will not qualify if you...
- History of cardiac conditions including atrial fibrillation, recent myocardial infarction, prolonged QT syndrome, or reduced heart function (LVEF < 50%, LVSF < 30%)
- Active graft-versus-host disease (GVHD)
- Severe lung function impairment
- Advanced stage of other malignant tumors
- Severe or uncontrolled infections
- Severe autoimmune diseases or innate immune deficiencies
- Active hepatitis B or C infection with abnormal liver function
- HIV or syphilis infection
- History of severe allergic reactions to biological products
- Central nervous system disorders such as uncontrolled epilepsy or dementia
- Female patients who are pregnant, breastfeeding, or planning pregnancy within 12 months
- Any condition that may increase risk or interfere with study results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
M
Mei Heng, M.D., Ph.D
CONTACT
Y
Yun Kang
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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