Actively Recruiting
Clinical Study of the Safety and Efficacy of ASCT Combined With CD7-CART in the Treatment of CD7+ TCL
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-06
50
Participants Needed
1
Research Sites
240 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
H
Hebei Taihe Chunyu Biotechnology Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
To evaluate the safety and efficacy of autologous hematopoietic stem cell transfer (ASCT) combined with CD7-CART in the treatment of CD7+ TCL
CONDITIONS
Official Title
Clinical Study of the Safety and Efficacy of ASCT Combined With CD7-CART in the Treatment of CD7+ TCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to consent and follow study visits, treatments, tests, and procedures
- Age 18 to 65 years, male or female
- Confirmed T-cell non-Hodgkin's lymphoma (including T-lymphoblastic lymphoma/leukemia) per WHO 2022 criteria
- Meets one of these: newly diagnosed with high-risk factors; not achieving partial remission or better after therapy; or not suitable for allogeneic stem cell transplant
- Tumor cells express CD7 confirmed by pathology or cytology at screening
- Adequate organ function including liver enzymes, bilirubin, kidney function, blood clotting times, lung reserve, and heart function
- Negative pregnancy test for women of childbearing age within 7 days before infusion
- Agree to use effective contraception during study and for at least 2 years after treatment
You will not qualify if you...
- Allergy to any components of the cell product
- Severe heart disease such as recent myocardial infarction, unstable angina, severe arrhythmias, severe cardiomyopathy, or advanced heart failure
- Prior autologous or allogeneic hematopoietic stem cell transplantation
- Stroke or seizure within 6 months before consent
- Autoimmune diseases, immunodeficiencies, or conditions needing immunosuppressants
- Other cancers within 3 years prior, except certain treated localized cancers without recurrence
- Uncontrolled active infections
- Severe systemic diseases requiring treatment
- Recent infections with hepatitis B, hepatitis C, HIV, syphilis, or CMV
- Use of high-dose corticosteroids within 1 week before lymphocyte collection
- Previous CAR-T or genetically modified T-cell therapy
- Prior CD7-targeted therapy
- Live vaccination within 4 weeks before consent
- History of alcoholism, drug abuse, or mental illness
- 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
Blood Disease Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
L
Liang Huang, Dr
CONTACT
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