CD30 CAR-T in the Treatment of CD30 Positive Lymphoma (NCT07048353) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
CD30 CAR-T in the Treatment of CD30 Positive Lymphoma
China15 participantsStarted 2025-07-28
Plain-language 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。
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ba…
What they're measuring
1
To evaluate safety and dose limiting toxicities (DLT) of autologous CD30 CAR-T and establish the recommended Phase dose