Actively Recruiting
Clinical Study on the Safety and Efficacy of CD30 CAR-T Cells for CD30 Positive Relapsed/Refractory Lymphoma
Led by Shanxi Bethune Hospital · Updated on 2025-02-27
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of CD30 CAR-T cell therapy in treating patients with CD30-positive relapsed or refractory lymphoma. This prospective, open-label study aims to understand how this therapy works in the body and how different doses may impact treatment outcomes. The trial plans to enroll 15 subjects aged 15 to 80 years who have not responded to or relapsed after previous treatments including stem cell transplantation or brentuximab vedotin therapy. Participants will receive a single intravenous infusion of autologous CD30 CAR-T cells at one of three dose levels: 1 million, 2 million, or 5 million CAR-positive T cells per kilogram of body weight. The infusion is performed using a blood transfusion apparatus with a filter and saline rinsing. The study will assess the safety, dose-limiting toxicities, and efficacy of the treatment, as well as monitor the metabolism of the infused cells in the patients. During the study, participants will be closely monitored for responses and side effects over six months to evaluate overall response rates. Additional follow-up for disease-free and overall survival will continue for up to three years. Assessments include clinical evaluations, laboratory tests, imaging according to the Lugano 2014 criteria, and performance status measures. Safety monitoring focuses on organ function, blood counts, and potential toxicities related to the therapy. The total duration of participation may extend up to three years to fully understand treatment impact and safety.
CONDITIONS
Brief Title
CD30 CAR-T in the Treatment of CD30 Positive Relapsed/Refractory Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 15 to 80 years, male or female
- Diagnosed with CD30 positive lymphocyte malignancies
- CD30 expression greater than 10% confirmed by immunohistochemistry
- At least one measurable lesion per Lugano 2014 criteria
- Not suitable for or relapsed after autologous hematopoietic stem cell transplantation
- Not suitable for or relapsed after brentuximab vedotin treatment
- Estimated survival time of at least 3 months
- ECOG performance status 0 to 2 and Karnofsky performance score above 60%
- Adequate organ function including liver enzymes, bilirubin, kidney function, heart function, and oxygen saturation
- Blood counts meeting minimum thresholds and suitable venous access for apheresis
- No central nervous system lymphoma involvement on MRI
- Willingness to use reliable contraception if fertile
- Ability to understand and voluntarily sign informed consent
You will not qualify if you...
- Lymphoma-associated hemophagocytic syndrome
- Pregnant or breastfeeding women, or planning pregnancy within six months
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis except controlled hepatitis B DNA
- Other active malignancies except certain treated skin or cervical cancers
- Received Anti-CD30 antibody therapy within 4 weeks prior to enrollment
- Unresolved significant non-hematologic toxicities from prior treatments
- Active uncontrolled bleeding or bleeding disorders
- Autologous stem cell transplantation within 6 weeks
- Uncontrolled bacterial or fungal infections
- Known allergy to study drug or components
- Active autoimmune diseases requiring systemic treatment
- Mental illness preventing cooperation with treatment or evaluation
- Participation in other clinical trials within 1 month
- History of allogeneic stem cell transplantation
- Any condition deemed by the investigator to interfere with safety or trial 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.
Duration - 28 days
Participants receive a single low-dose infusion of CD30 CAR-T cells to treat CD30 positive relapsed/refractory lymphoma.
1 infusion visit and multiple follow-up visits during treatment period
Trial Site Locations
Total: 1 location
1
Shanxi Bethune Hospital
Taiyuan, Shangxi, China
Actively Recruiting
Research Team
J
jia wei
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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