Overview
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。
Description
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
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.