CD30 CAR-T in the Treatment of CD30 Positive Relapsed/Refrac...

About this study

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。

Condition: Lymphoma, B-Cell
Tested: chimeric antigen receptor gene modified T cells
Sponsor: Shanxi Bethune Hospital

Who can join

Age: 15 to 80 years
Sex: All sexes
Healthy volunteers: Not accepted

Inclusion 16

Minimum age: 15 years
Maximum age: 80 years
Study condition: Lymphoma, B-Cell
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 15

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.

Where

1 site, 1 recruiting

Shanxi Bethune Hospital

Taiyuan, Shangxi, China

Recruiting

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