Clinical Trials Directory

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UnknownNCT05208853

An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti CD30 CAR T Cells in Patients With CD30+ Relapsed/Refractory Lymphoma

An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti CD30 CAR T Cells Injection (Anti CD30 CAR T Cells) in Patients With CD30+ Relapsed/Refractory Lymphoma

Status
Unknown
Phase
EARLY_Phase 1
Study type
Interventional
Enrollment
9 (estimated)
Sponsor
Zhejiang University · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

This is a single-center, open label, single dose study of anti CD30 CAR-T cells injection in treatment of patients with relapsed/refractory CD30+ lymphoma.

Detailed description

This study is a single-center, open-label, single dose study of anti CD30 CAR-T cells injection in treatment of patients with relapsed/refractory CD30+ lymphoma. This study intends to include CD30-positive patients with relapsed/refractory CD30+ lymphoma, and subjects will receive a single injection of anti CD30 CAR-T cells after screening, Peripheral Blood Mononuclear Cell (PBMC) collection, and lymphodepletion chemotherapy pretreatment. Response assessments for lymphoma subjects will base on 2018 Lugano Classification.

Conditions

Interventions

TypeNameDescription
BIOLOGICALAnti CD30 CAR-T Cell InjectionAfter enrollment, subjects complete the apheresis, then complete the lymphodepletion, and then receive the dose escalation test: 1.5×10\^7 cells，1.5×10\^8 cells，5× 10\^8 cells. Drug: Fludarabine Fludarabine is used for lymphodepletion. Drug: Cyclophosphamide Cyclophosphamide is used for lymphodepletion

Timeline

Start date
2022-02-10
Primary completion
2022-02-10
Completion
2022-02-10
First posted
2022-01-26
Last updated
2022-01-26

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05208853. Inclusion in this directory is not an endorsement.