Actively Recruiting
Clinical Study of Anti-CD56-CAR-T in the Treatment of Relapsed/Refractory NK/T Cell Lymphoma /NK Cell Leukemia
Led by The Affiliated Hospital of Xuzhou Medical University · Updated on 2023-07-12
20
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety and efficacy of anti-CD56-CAR T in the treatment of relapsed refractory NK/T cell lymphoma /NK cell leukemia
CONDITIONS
Official Title
Clinical Study of Anti-CD56-CAR-T in the Treatment of Relapsed/Refractory NK/T Cell Lymphoma /NK Cell Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients or their legal guardians voluntarily agree and sign informed consent
- Male or female patients aged 18 to 70 years (inclusive)
- Diagnosed with NK/T cell lymphoma or NK cell leukemia by pathology or flow cytometry
- Have relapsed after chemotherapy or stem cell transplant, or have no effective treatment options
- Includes patients with no remission or residual lesions after treatment unsuitable for HSCT, relapse after CR unsuitable for HSCT, high-risk patients, or relapse/no remission after transplant or cellular immunotherapy
- Measurable or evaluable lesions present
- Good liver function (ALT/AST less than 3 times upper limit, total bilirubin ≤34.2 µmol/L)
- Good kidney function (creatinine less than 220 µmol/L)
- Lung oxygen saturation ≥95%
- Cardiac function with left ventricular ejection fraction ≥40%
- No anti-cancer treatment in 4 weeks before enrollment and prior treatment toxicities recovered to grade 1 or less (except hair loss)
- Peripheral venous access suitable for infusion
- ECOG performance status 0-2 and expected survival of at least 3 months
You will not qualify if you...
- Pregnant or breastfeeding women
- Men or women planning pregnancy within 1 year or not using effective contraception for 1 year after enrollment
- Uncontrolled infections within 4 weeks before enrollment
- Active hepatitis B or C infection
- HIV infection
- Serious autoimmune or immunodeficiency diseases
- Allergies to antibodies, cytokines, or similar biological drugs
- Participation in other clinical trials within 6 weeks before enrollment
- Systemic hormone use within 4 weeks before enrollment (except inhaled hormones)
- Mental illness
- Substance abuse or addiction
- Other conditions judged by researchers as unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221002
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here