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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04665076
Other study ID # 2020104
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 22, 2020
Est. completion date October 21, 2025

Study information

Verified date October 2020
Source Hebei Senlang Biotechnology Inc., Ltd.
Contact Jianqiang Li, PhD & MD
Phone 008615511369555
Email limmune@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a multi-center, non-randomized, single-arm, open clinical trial.


Description:

A single car consists of scFv, hinge region, transmembrane region, costimulatory domain and zeta subunit of CD3.Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.


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Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Auto CAR-T
Biological: Auto CAR-T
Drug:
Cyclophosphamide,Fludarabine
Drug: Cyclophosphamide,Fludarabine
Procedure:
Leukapheresis
Leukapheresis

Locations

Country Name City State
China Hematology Department, Hebei Medical University Fourth Hospital Shijiazhuang Hebei

Sponsors (2)

Lead Sponsor Collaborator
Hebei Senlang Biotechnology Inc., Ltd. Hebei Medical University Fourth Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety: Incidence and severity of adverse events To evaluate the possible adverse events occurred within first one month after CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity first one month after CAR-T infusion
Primary Efficacy: Remission Rate Remission Rate including complete remission (CR), partial remission (PR), objective response (ORR = CR + PR), disease stability (SD), disease progression (PD) and unresponsive (NR) 3 months post CAR-T cells infusion
Secondary Efficacy:duration of response (DOR) duration of response (DOR) 24 months after CAR-T infusion
Secondary Efficacy: progression-free survival (PFS) progression-free survival (PFS) time 24 months after CAR-T infusion