Clinical Trial: PCAR-119 Bridge Immunotherapy Prior to Stem Cell Transplant in Treating Patients With CD19 Positive Leukemia and Lymphoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: PCAR-119 Bridge Immunotherapy Prior to Stem Cell Transplant in Treating Patients With CD19 Positive Relapsed or Refractory Leukemia and Lymphoma

Brief Summary: The purpose of this study is to evaluate the safety and optimal dose of PCAR-119 in patients who are going to receive stem cell transplantation but without available treatment to achieve complete remission prior to the transplant.

Detailed Summary: The purpose of this study is to evaluate the safety and optimal dose of PCAR-119 in patients who are going to receive stem cell transplantation but without available treatment to achieve complete remission prior to the transplant. In addition, some patients who enroll to other CD19-CAR-T cell therapy trials might be eligible for this trial if their CD19-CAR-T cells cannot be produced successfully because they have insufficient T cells to allow the CD19-CAR-T cells to be made; their T cells are inefficiently transduced with CAR viruses; or their CAR-T cell expansion is failed.
Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Current Primary Outcome: Adverse events attributed to the administration of the anti-CD19 CAR-NK cells [ Time Frame: 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Objective Response Rate [ Time Frame: Safety follow-up is 100 days from last CAR-NK infusion ]

Original Secondary Outcome: Same as current

Information By: PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Dates:
Date Received: September 2, 2016
Date Started: September 2016
Date Completion: September 2019
Last Updated: December 4, 2016
Last Verified: December 2016