Clinical Trial: Study of TBI-1501 for Relapsed or Refractory Acute Lymphoblastic Leukemia

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Multicenter Phase I/II Study for Relapsed or Refractory CD19+ B-acute Lymphoblastic Leukemia

Brief Summary: Evaluate the safety (P-I), pharmacokinetics and anti-tumor effect of immunotherapy of autologous T cells genetically modified to express anti-CD19 chimeric antigen receptor (CAR) (TBI-1501) for relapsed or refractory CD19+ B-cell acute lymphoblastic leukemia.

Detailed Summary:

Enroll patients after confirming eligibility. Following enrollment, peripheral blood mononuclear cells and blood plasma will be obtained from each subject by apheresis to start the manufacturing of TBI-1501.

Before TBI-1501 administration, it is necessary to pass the quality tests. Subject will be hospitalized from Day -3 to Day 28, and administered Cyclophosphamide (1,000 mg/m2/day×2 days) on Day -3 and Day -2.

Sponsor: Takara Bio Inc.

Current Primary Outcome:

• Phase-I portion: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: One year ]
  Adverse event (frequency, seriousness, duration, causality, severity, classification), mortality, severe adverse event, discontinuation due to adverse event.
• Phase-II portion: Anti-tumor effect (CR+CRi rate) [ Time Frame: 56 days ]
  Complete Remission (CR)+Complete Remission with Incomplete Blood Count Recovery (CRi) , as determined by assessments of peripheral blood and bone marrow.

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Takara Bio Inc.

Dates:
Date Received: April 14, 2017
Date Started: June 1, 2017
Date Completion: March 31, 2020
Last Updated: May 15, 2017
Last Verified: May 2017