Actively Recruiting
A Clinical Study of the Safety and Efficacy of Autologous Hematopoietic Stem Cell Transplantation in Combination With CD7-CART in the Treatment of CD7+ T-Cell Lymphoma
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-06
50
Participants Needed
1
Research Sites
52 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
Researchers are evaluating the safety and effectiveness of combining autologous hematopoietic stem cell transplantation (ASCT) with CD7-CAR T-cell therapy (CD7-CART) for treating patients with CD7-positive T-cell lymphoma (TCL). This Phase 2 clinical trial focuses on patients diagnosed with this type of lymphoma, aiming to understand how this combined approach impacts disease progression and adverse effects over time. Participants will receive an intravenous infusion of CD7-CART three days after undergoing ASCT. The study will monitor patients for up to two years following treatment to assess outcomes such as progression-free survival, response duration, and overall survival. The trial includes careful evaluation of treatment-related side effects and detailed measurement of therapy impact at multiple timepoints. Throughout the trial, participants will undergo regular visits for laboratory tests, imaging, and clinical assessments to track disease status and safety. Researchers will collect data on minimal residual disease negativity, response times, and drug concentration levels in the body. Safety monitoring will continue for two years after treatment, ensuring comprehensive follow-up of each participant's health and response to the combined therapies.
CONDITIONS
Brief 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 follow study visits, treatment, lab tests, and procedures with signed consent
- Age between 18 and 65 years, male or female
- Diagnosed with T-cell non-Hodgkin's lymphoma, including T-lymphoblastic lymphoma/leukemia, meeting high-risk or treatment criteria
- Tumor cells confirmed positive for CD7 at screening
- Adequate organ function as defined by liver enzymes, bilirubin, kidney function, blood clotting, lung reserve, and heart function
- Women of childbearing age must have a negative pregnancy test and participants must agree to use effective contraception during and for 2 years after treatment
You will not qualify if you...
- Allergy to any components of the cell product
- Severe heart conditions such as recent heart attack, 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 or immunodeficiencies needing immunosuppressive treatment
- Other cancers within 3 years except certain treated localized cancers without recurrence
- Active uncontrolled infection
- Unstable severe systemic diseases requiring medication
- Positive for certain viral infections or recent use of high-dose corticosteroids before lymphocyte collection
- Previous CAR-T or CD7-targeted therapies
- Live vaccination within 4 weeks before consent
- History of alcoholism, drug abuse, or mental illness
- Other investigator-determined unsuitable conditions for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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 2 years
Participants receive autologous hematopoietic stem cell transplantation (ASCT) followed by an intravenous infusion of CD7-CART 3 days after ASCT.
Multiple visits during treatment and monitoring period
Duration - Up to 2 years after treatment
Participants are monitored for progression-free survival, overall survival, adverse events, and treatment response after ASCT combined with CD7-CART.
Regular visits over 2 years for assessments
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
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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