NCT07048353

CD30 CAR-T in the Treatment of CD30 Positive Lymphoma

Clinical Study on the Safety and Efficacy of Chimeric Antigen Receptor Gene Modified T Cells Targeting CD30 in the Treatment of CD30 Positive Relapsed/Refractory Lymphoma

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Shandong Qilu Cell Therapy Engineering Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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。

Detailed description

The goal of this clinical trial is to explore the efficacy and safety of CD30 CAR-T on CD30 positive relapsed/refractory lymphoma. The main questions it aims to answer are: To evaluate the safety and maximum tolerated dose of autologous CD30 CAR-T therapy in CD30-positive relapsed/refractory lymphoma; To evaluate the efficacy of autologous CD30 CAR-T therapy for CD30-positive relapsed/refractory lymphoma; To evaluate the metabolism of CD30 CAR-T cells in vivo; Preliminary evaluation of the correlation between CAR T cell dose and clinical efficacy.

Conditions

• Lymphoma
• B Cell Lymphoma
• CD30+ Peripheral T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2025-07-28
• Primary completion: 2029-07-28
• Completion: 2029-07-28
• First posted: 2025-07-02
• Last updated: 2025-07-02

Locations

1 site across 1 country: China