CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas
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|ClinicalTrials.gov Identifier: NCT03383965|
Recruitment Status : Recruiting
First Posted : December 27, 2017
Last Update Posted : December 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin Lymphoma Anaplastic Large Cell Lymphoma||Biological: ICAR30 T cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||None (Open Label)|
|Official Title:||A Clinical Study of CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas|
|Actual Study Start Date :||March 1, 2017|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2025|
Experimental: ICAR30 T cells
anti-CD30 CAR-T cells. Patients receive ICAR30 T cells infusion.
Biological: ICAR30 T cells
T cells were isolated from peripheral blood from patients enrolled. T cells were transduced with lentivirus bearing anti-CD30 antibody scFV and the activation signals of second generation CART designation. The CART cells were infused into the patients by IV with an escalating dosage.
Other Name: Biological drug
- Measure the safety of ICAR30 T cells [ Time Frame: 2 years ]To assess the adverse events of ICAR30 T cells infusion in patients with Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma.
- Measure the anti-tumor effect of ICAR30 T cells [ Time Frame: 3 years ]To assess the anti-tumor effect of ICAR30 T cells infusion in patients with Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma.
- Measure the survival time of ICAR30 T cells in vivo [ Time Frame: 5 years ]To measure the survival time of ICAR30 T cells in vivo, extra blood will be drawn from patients receive ICAR30 T cells infusion in the follow-up time.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383965
|Contact: Xiulian Sun, MD.,Ph.D||(+86) email@example.com|
|Weifang People's Hospital||Recruiting|
|Weifang, Shandong, China, 261000|
|Contact: Xiulian Sun, M.D., Ph.D (+86) 010-62420689 firstname.lastname@example.org|
|Contact: Xuehong Ran, Doctor 0536-8192117 email@example.com|