CELL INTELLIGENCE · 肿瘤细胞治疗研究

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\<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 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.

主要终点：Overall response rate · Including complete remission (CR) and partial remission (PR) · 6 months；To evaluate safety and dose limiting toxicities (DLT) of autologous CD30 CAR-T and establish the recommended Phase dose · Incidence of DLTs and occurrence of study related adverse events · 28 days
次要终点：Disease-free survival；Overall Survival

• Group1 · EXPERIMENTAL · Subjects received a single low-dose CD30 CAR-T therapy(1\*10\^6/kg CAR+T cells)
• Group2 · EXPERIMENTAL · Subjects received a single low-dose CD30 CAR-T therapy(2\*10\^6/kg CAR+T cells)
• Group3 · EXPERIMENTAL · Subjects received a single low-dose CD30 CAR-T therapy(5\*10\^6/kg CAR+T cells)

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。