Clinical Trial: CAR-pNK Cell Immunotherapy in CD7 Positive Leukemia and Lymphoma

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

Official Title: Chimeric Antigen Receptor-Modified pNK Cells for CD7 Positive Relapsed or Refractory Leukemia and Lymphoma

Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of CAR-pNK cell immunotherapy in patients with CD7 positive relapsed or refractory Leukemia and Lymphoma.

Detailed Summary:
Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Current Primary Outcome: Adverse events attributed to the administration of the anti-CD7 CAR-pNK cells [ Time Frame: 2 years ]

Determine the toxicity profile of the CD7 targeted CAR-pNK cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical response to CD7 CAR-pNK cell infusions [ Time Frame: Safety follow-up is 100 days from last CAR-pNK infusion ]
    Patients with measurable disease will be assessed for the response of their disease to CD7 CAR-pNK cell treatment.
  • Determine the existence of CD7-CAR-pNK in vivo [ Time Frame: 1 year ]


Original Secondary Outcome: Same as current

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

Dates:
Date Received: March 31, 2016
Date Started: March 2016
Date Completion: March 2018
Last Updated: December 4, 2016
Last Verified: December 2016