A Study Evaluating KTE-C19 in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-3)

Official Title

A Phase 1/2 Multi-Centre Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL) (ZUMA-3)

Summary:

The primary objectives of this study are to determine the safety and efficacy of KTE-C19 adult participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL).

Trial Description

Primary Outcome:

  • Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
  • Phase 2: Overall complete remission rate
Secondary Outcome:
  • Duration of Remission
  • Minimum Residual Disease Negative Remission Rate
  • Allogeneic Stem Cell Transplant Rate
  • Overall Survival
  • Relapse-free Survival (RFS)
  • Percentage of Participants Experiencing Treatment-Emergent Adverse Events
  • Incidence of anti-KTE-C19 antibodies
  • Changes over time in the EQ-5D score and VAS score (Phase 2)
  • Percentage of Participants Experiencing Common Terminology Criteria for Adverse Events (CTCAE) Grade Changes in Safety Laboratory Values

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society