Clinical Trial: CAR-T Cell Immunotherapy in CD19 Positive Relapsed or Refractory Leukemia and Lymphoma
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Study Evaluating the Efficacy and Safety of PCAR-019 in CD19 Positive Relapsed or Refractory Leukemia and Lymphoma
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell immunotherapy in patients with CD19 positive relapsed or refractory Leukemia and Lymphoma.
Detailed Summary:
Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Current Primary Outcome: Phase I: Adverse events attributed to the administration of the anti-CD19 CAR-T cells [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Phase II: Objective Response Rate [ Time Frame: Safety follow-up is 100 days from last CAR-T infusion. ]
Original Secondary Outcome: Same as current
Information By: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Dates:
Date Received: June 28, 2016
Date Started: October 2016
Date Completion: September 2019
Last Updated: October 23, 2016
Last Verified: October 2016