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Clinical Trials in China / NCT07048353
Starting soon Phase EARLY_PHASE1

CD30 CAR-T in the Treatment of CD30 Positive Lymphoma

NCT07048353 · tracked via the Priya Life Science China tracker
Sponsor
Shandong Qilu Cell Therapy Engineering Technology Co., Ltd
Phase
Phase EARLY_PHASE1
Started
2025-07-28
Last updated
2025-07-02

Condition(s) studied

LymphomaB Cell LymphomaCD30+ Peripheral T-cell Lymphoma

Investigational drug(s) / intervention(s)

chimeric antigen receptor gene modified T cells

chimeric 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.

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。

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Tongji Hospital Affiliated to Tongji Medical College of HUST Wuhan Hubei

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07048353 on ClinicalTrials.gov ↗ ← All trials in China