RecruitingNot ApplicableNCT06850285

CD30 CAR-T in the Treatment of CD30 Positive Relapsed/Refractory Lymphoma

Clinical Study on the Safety and Efficacy of Chimeric Antigen Receptor Gene Modified T Cells Targeting CD30 in the Treatment of CD30 Positive Relapsed/Refractory Lymphoma

Sponsor

Shanxi Bethune Hospital

Enrollment

15 participants

Start Date

Sep 5, 2025

Study Type

INTERVENTIONAL

Conditions

Lymphoma, B-Cell

Summary

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。

Eligibility

Min Age: 15 YearsMax Age: 80 Years

Inclusion Criteria13

Age≥15 years and ≤80years，female and male；
CD30+ lymphocyte malignancies;
CD30 expression \>10% by immunohistochemistry；
At least 1 measurable lesion can be measured according to theLugano 2014 evaluation criteria;
Not suitable for autologous hematopoietic stem cell transplantation or recurrence after autologous hematopoietic stem cell transplantation;
Not suitable for BV treatment or relapse after BV treatment, and the expression of CD30 was confirmed by histology;
The estimated survival time ≥3 months;
ECOG performance status 0-2，KPS\>60%;
Sufficient organ function：ALT，AST≤2.5×ULN，patients with liver invasion can be relaxed to ≤ 5 x ULN；serum total bilirubin\<34 μmol/L；creatinine clearance rate\>30 mL/min；EF≥40%；No pericardial effusion and obvious arrhythmia；SpO2≥92%；
ALC ≥0.5×109/L，PLT\>30×109/L，Hb\>80 g/L and subjects had apheresis venous access and no contraindications for blood cell separation;
MRI showed no central involvement of lymphoma;
Patients with fertility must be willing to be able to use reliable contraceptive measures ;
The subject or legal guardian can understand and voluntarily sign the written informed consent.

Exclusion Criteria15

Lymphoma-associated hemophagic cell syndrome;
Pregnant or lactating women, and women who have a pregnancy plan within six months;
Hepatitis B（HBsAg、HBsAb、HBeAg、HBeAb、HBcAb），Hepatitis C（Anti-HCV），Anti-HIV Ⅰ/Ⅱ and anti-TP positive（Hepatitis B DNA test is negative except）;
Suffered from other malignant tumors, except for for skin basal cell carcinoma, skin squamous cell carcinoma and cervical carcinoma in situ undergoing the radical treatment;
Received Anti-CD30 Ab therapy within 4 weeks before enrollment;
Unresolved \> Grade 1 non-hematologic toxicity associated with any prior treatments;
Active uncontrolled bleeding or a known bleeding diathesis;
Autologous hematopoietic stem cell transplantation was performed within 6 weeks;
Uncontrollable active bacterial or fungal infection；
Known allergy to the study drug and its components;
Suffer from active autoimmune diseases that require systemic treatment ;
Persons with mental or mental illness who cannot cooperate with treatment and efficacy evaluation;
Participated in other clinical studies within 1 months prior to this study;
History of allogeneic hematopoietic stem cell transplantation;
patients with any condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject.

Interventions

DRUGchimeric antigen receptor gene modified T cells

The rate of intravenous infusion of CD30 CAR T cells was 10 mL to 20 mL/min, and the infusion was performed using a blood transfusion apparatus with a filter screen. Use saline rinsing tube prior to infusion; Rinse the infusion bag with 10 mL\~30 mL normal saline.