NCT04008394

Anti-CD30 CAR-T Therapy in Patients With Refractory/Relapsed Lymphocyte Malignancies

Efficacy and Safety of Anti-CD30 CAR-T Therapy in Patients With Refractory/Relapsed Lymphocyte Malignancies：a Single-center, Open, Single-arm Clinical Study.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The overall purpose of this study is to explore the safety and therapeutic effect of CD30-targeted chimeric antigen receptor T(CAR-T) cells in the treatment of Refractory/Relapsed lymphocyte malignancies.

Detailed description

Chimeric antigen receptor (CAR)-modified T cells (CAR-T cells) have the capabilities to recognize tumor associated antigen and kill tumor cells specifically. CD30 is originally described as a marker of Hodgkin's and R-S cells in Hodgkin's lymphoma. CD30 antibody has been applied to treat lymphocyte derived malignancies. To explore the potency of CD30 in CAR-T therapy, this trial is designed and conducted to test the safety and efficacy of CD30-targeted CAR-T in Refractory/Relapsed lymphocyte malignancies.

Conditions

• Adult T-Cell Lymphoma/Leukaemia
• Anaplastic Large Cell Lymphoma
• Angioimmunoblastic T-cell Lymphoma
• NK/T-cell Lymphoma
• Peripheral T Cell Lymphoma
• Hodgkin Lymphoma

Interventions

Type	Name	Description
GENETIC	Anti-CD30 CAR T cells	Patients receive CD30 CAR-T cells transduced with a lentiviral vector on day 0 in the absence of disease progression or unacceptable toxicity. Autologous 3th generation anti-CD30 CAR T cells.

Timeline

• Start date: 2019-07-03
• Primary completion: 2022-07-01
• Completion: 2023-01-01
• First posted: 2019-07-05
• Last updated: 2019-08-07

Locations

1 site across 1 country: China