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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02876978
Other study ID # CG1003
Secondary ID
Status Recruiting
Phase Phase 1
First received August 9, 2016
Last updated August 23, 2016
Start date March 2016
Est. completion date April 2019

Study information

Verified date August 2016
Source Carsgen Therapeutics, Ltd.
Contact Li Zonghai, MD
Phone 86-21-54489926
Email zonghaili@carsgen.com
Is FDA regulated No
Health authority China: National Health and Family Planning CommissionChina: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to observe and confirm the safety, tolerance and cell pharmacokinetics of lentivirus-transduced CAR-GPC3 T cells (CAR-GPC3 T cells targeting GPC3)


Description:

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Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Genetic:
CAR-GPC3 T Cells
Intravenous infusion of CAR-GPC3 T cells is conducted 1 - 2 days following lymphodepletion.
Drug:
Fludarabine
30 mg/m^2/day x 4 days
Cyclophosphamide
500 mg/m^2/day x 2 days

Locations

Country Name City State
China Shanghai Chest Hospital,Shanghai Jiaotong University Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Carsgen Therapeutics, Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and tolerance: Occurrence of study related adverse events Occurrence of study related adverse events, defined as laboratory toxicities and clinical events that are possibly, likely or definitely related to study treatment at any time from the infusion until week 24. This will include infusive toxicity, and any toxicity possibly related to the CAR-GPC3 T cells. 24 weeks Yes
Secondary Engraftment: the DNA vector copies per mL blood of CAR-GPC3 T cells The DNA vector copies per mL blood of CAR-GPC3 T cells on week 4 after the first infusion by Q-PCR. Q-PCR for CAR-GPC3 vector sequences will also be performed after infusion thereafter until any 2 sequential tests are negative documenting loss of CAR-GPC3 T cells within 2 years. 2 years Yes
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