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 Years – 65 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.