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NCT07048353

CD30 CAR-T in the Treatment of CD30 Positive Lymphoma

RecruitingEARLY_PHASE1

Study summary

The is a prospective, open-label, dose-climbing multicenter 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。

At a glance

Conditions
Lymphoma, B Cell Lymphoma, CD30+ Peripheral T-cell Lymphoma
Interventions
chimeric antigen receptor gene modified T cells
Lead sponsor
Shandong Qilu Cell Therapy Engineering Technology Co., Ltd
Target enrollment
15 participants
Age
18 Years65 Years
Sex
ALL
Locations
Tongji Hospital Affiliated to Tongji Medical College of HUST
Registry
View on ClinicalTrials.gov ↗

Eligibility criteria

Inclusion Criteria: * Age≥18 years and ≤65years,female and male; * CD30+ recurrent/refractory malignant hematological malignancies, experienced recurrence (disease progression after treatment remission) or refractory (previous systemic treatment did not achieve CR) after ≥ 2-line systemic treatment; * CD30 expression \>10% by immunohistochemistry; * At least 1 measurable lesion can be measured according to theLugano 2014 evaluation criteria; * 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.