CD30 CAR-T in the Treatment of CD30 Positive Relapsed/Refractory Lymphoma

ConditionLymphoma, B-Cell

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age15-80

SponsorShanxi Bethune Hospital

About this trial

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。

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Sequential

Treatments tested in this trial

chimeric antigen receptor gene modified T cells
Drug
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.

Treatment groups

15 Participants

are divided into 3 treatment groups

Group A: Group1Experimental treatment 1 intervention

Group B: Group2Experimental treatment 1 intervention

Group C: Group3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Overall response rate

Including complete remission (CR) and partial remission (PR)

Time frame

6 months

To evaluate safety and dose limiting toxicities (DLT) of autologous CD30 CAR-T and establish the recommended Phase dose

Incidence of DLTs and occurrence of study related adverse events

Time frame

28 days

Secondary outcomes

Disease-free survival

DFS was calculated from the first CAR-T cell infusion to death, progression of the disease, relapse or gene recurrence, whichever came first, or last visit.

Time frame

3years

Overall Survival

OS was calculated from the first CAR-T cell infusion to death or last follow-up

Time frame

3 years

Other outcomes

The copy number of CD30 CAR-T cells

The copy number of CD30 CAR-T cells amplified in peripheral blood after administration

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanxi Bethune Hospital

Lead sponsor

Source ClinicalTrials.gov

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