cd30 car-t in the treatment of cd30 positive relapsed/refractory lymphoma

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。

the goal of this clinical trial is to explore the effect of cd30 car-t on cd30 positive relapsed/refractory lymphoma. the main questions it aims to answer are: to evaluate the safety of autologous cd30 car-t therapy in cd30-positive relapsed/refractory lymphoma; to evaluate the efficacy of autologous cd30 car-t therapy for cd30-positive relapsed/refractory lymphoma; to evaluate the metabolism of cd30 car-t cells in vivo; preliminary evaluation of the correlation between car t cell dose and clinical efficacy.

Eligibility criteria:
inclusion criteria: * 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\ 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 criteria: * 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.

Keywords: cd30 car-t; lymphoma;