Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at UCSF
Dates
study started
estimated completion

Description

Summary

Phase I, first-in-human, open-label, dose-escalation and dose-expansion study evaluating the safety and efficacy of UCART targeting CD123 in patients with relapsed/refractory acute myeloid leukemia (AML). The purpose of this study is to evaluate the safety and clinical activity of UCART123v1.2 and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D).

Official Title

Phase I, Open Label Dose Escalation and Dose-Expansion Study to Evaluate the Safety, Expansion, Persistence, and Clinical Activity of UCART123 (Allogeneic Engineered T-cells Expressing Anti-CD123 Chimeric Antigen Receptor), Administered in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Keywords

Relapsed/Refractory Acute Myeloid Leukemia Acute Myeloid Leukemia Chimeric Antigen Receptor T-Cell (CAR-T) therapy Allogeneic Transcription Activator-Like Effector Nuclease (TALEN) Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute UCART123v1.2

Eligibility

You can join if…

Open to people ages 18-65

  • Patients with relapsed or primary refractory AML (as defined in WHO criteria) with >5% bone marrow blasts
  • Patients with CD123+ blast cells (verified by flow cytometry)
  • Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of ≤1
  • Adequate organ function, including bone marrow, renal, hepatic, pulmonary, and cardiac function based on the last assessment performed within screening period
  • (Dose-escalation) Identified donor and transplant strategy prior to lymphodepletion (LD)
  • Other criteria may apply

You CAN'T join if...

  • Patients with APL or CNS Leukemia
  • Previous investigation gene or cell therapy (including CAR)
  • ≥ 2 prior allogeneic SCTs
  • Prior treatment with rituximab or other anti-CD20 therapy within 3 months
  • Any known active or uncontrolled infection
  • Other criteria may apply

Locations

  • University of California, San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94143 United States
  • MD Anderson Cancer Center accepting new patients
    Houston Texas 77030 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Cellectis S.A.
ID
NCT03190278
Phase
Phase 1
Study Type
Interventional
Last Updated