Actively Recruiting
CD7 CAR-T Cells in T-cell Lymphoma/Leukemia
Led by Shenzhen University General Hospital · Updated on 2022-11-17
20
Participants Needed
1
Research Sites
317 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
T-cell lymphoma/leukemia is a group of highly lethal diseases with a high relapse rate and poor prognosis. CD7 was proved to be widely expressed in T-cell malignant, which makes it a promising therapeutic target. In this study we aim to test the safety and efficacy of CD7 CAR-T cells in T-cell lymphoma/leukemia.
CONDITIONS
Official Title
CD7 CAR-T Cells in T-cell Lymphoma/Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender
- Voluntary participation with signed informed consent
- Diagnosed with T-cell lymphoma according to NCCN guidelines
- Relapsed or refractory T-cell lymphoma, including failure to achieve complete remission after induction therapy or presence of disease in blood, bone marrow, or other sites
- No antibody therapy within 2 weeks before cell therapy
- ECOG performance status of 0 to 2
- No contraindications for peripheral blood collection
- Expected survival time longer than 3 months
You will not qualify if you...
- Allergy to any components of the cell therapy products
- Abnormal laboratory tests: bilirubin ≥ 1.5 mg/dl, ALT or AST > 2.5 times normal, creatinine ≥ 2.0 mg/dl, or platelet count ≤ 10 x 10^9/L
- Severe heart failure (NYHA class III or IV) or left ventricular ejection fraction < 50%
- Poor lung function with blood oxygen saturation < 92% on room air
- Recent serious heart events within 12 months, such as myocardial infarction or unstable angina
- Poorly controlled severe hypertension
- Presence of other advanced tumors unless stable after treatment
- History of serious neurological conditions like epilepsy or brain injury
- Known active central nervous system leukemia or ongoing CNS radiation therapy
- Autoimmune diseases or immunodeficiency requiring immunosuppressants
- Active uncontrolled infections
- Prior use of any CAR-T cell or genetically modified T-cell therapy
- Live vaccination within 4 weeks before enrollment
- Infections with HIV, HBV, HCV, or syphilis; HBV carriers
- History of alcoholism, drug addiction, or mental illness
- Participation in other clinical trials within 3 months
- For females: pregnancy, lactation, plans to become pregnant during the trial, or inability to use effective contraception
- Other conditions deemed unsuitable 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
Li Yu
Shenzhen, Guangdong, China, 518000
Actively Recruiting
Research Team
Y
Yu Li, Dr
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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