Actively Recruiting
CD30 CAR-T in the Treatment of CD30 Positive Relapsed/Refractory Lymphoma
Led by Shanxi Bethune Hospital · Updated on 2025-02-27
15
Participants Needed
1
Research Sites
142 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The is a prospective, open-label, dose-climbing clinical study assessing the efficacy and safety of CD30 CAR-T in the treatment of r/r CD30+ lymphoma. Plan to recruit 15 subjects with r/r CD30+ lymphoma。
CONDITIONS
Official 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, any gender
- Diagnosis of CD30-positive lymphocyte malignancies with CD30 expression over 10% by immunohistochemistry
- At least one measurable lesion according to Lugano 2014 criteria
- Not suitable for or have relapsed after autologous hematopoietic stem cell transplantation
- Not suitable for or have relapsed after brentuximab vedotin (BV) treatment, with confirmed CD30 expression by histology
- Estimated survival time of 3 months or more
- ECOG performance status 0 to 2 and Karnofsky performance score above 60%
- Sufficient organ function including liver enzymes ALT and AST less than or equal to 2.5 times upper limit of normal (up to 5 times if liver invaded), total bilirubin below 34 micromol/L, creatinine clearance above 30 mL/min, ejection fraction 40% or higher, no pericardial effusion or significant arrhythmia, oxygen saturation 92% or higher
- Blood counts: absolute lymphocyte count at least 0.5 x 10^9/L, platelets above 30 x 10^9/L, hemoglobin above 80 g/L
- Have venous access for apheresis and no contraindications for blood cell separation
- MRI shows no central nervous system involvement of lymphoma
- Fertile patients willing to use reliable contraception
- Ability to understand and voluntarily sign informed consent
You will not qualify if you...
- Lymphoma-associated hemophagocytic syndrome
- Pregnant or lactating women, or women planning pregnancy within 6 months
- Positive for hepatitis B (except negative hepatitis B DNA), hepatitis C, HIV, or syphilis tests
- History of other malignant tumors except treated skin basal cell carcinoma, skin squamous cell carcinoma, and cervical carcinoma in situ
- Received anti-CD30 antibody therapy within 4 weeks before enrollment
- Unresolved grade 2 or higher non-hematologic toxicity from prior treatments
- Active uncontrolled bleeding or known bleeding disorders
- Autologous hematopoietic stem cell transplantation within the last 6 weeks
- Uncontrollable active bacterial or fungal infections
- Known allergy to the study drug or its components
- Active autoimmune diseases requiring systemic treatment
- Mental illness preventing cooperation with treatment and evaluation
- Participation in other clinical trials within 1 month prior to this study
- History of allogeneic hematopoietic stem cell transplantation
- Any condition that the investigator or treating physician believes would interfere with the trial or participant safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanxi Bethune Hospital
Taiyuan, Shangxi, China
Actively Recruiting
Research Team
J
jia wei
CONTACT
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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