Study Evaluating Safety and Efficacy of UCART123v1.2 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

a study on Acute Myeloid Leukemia Leukemia

Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Rebecca Olin (ucsf)
Headshot of Rebecca Olin
Rebecca Olin

Description

Summary

Phase I, open-label, dose-escalation and dose-expansion study evaluating the safety and efficacy of Universal Chimeric Antigen Receptor T-cell (UCART) targeting the Cluster of Differentiation 123 (CD123) in patients with relapsed/refractory acute myeloid leukemia (AML). The purpose of this study is to evaluate the safety and clinical activity of Universal Chimeric Antigen Receptor T-cells targeting CD123 (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, Myeloid Leukemia, 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 World Health Organization [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 acute promyelocytic leukemia (APL) or central nervous system (CNS) Leukemia
  • Previous investigation gene or cell therapy (including CAR)
  • > 1 prior allogeneic stem cell transplantations (SCTs)
  • Prior treatment with rituximab or other anti-cluster of differentiation 20 (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

Lead Scientist at University of California Health

  • Rebecca Olin (ucsf)
    Dr. Rebecca Olin is a hematologist who specializes in bone marrow transplantation in adults. Her expertise encompasses treating acute leukemia, myelodysplastic and myeloproliferative disorders (conditions in which the bone marrow makes too many white blood cells) and aplastic anemia (a condition in which the body doesn’t make enough new blood cells).

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Cellectis S.A.
ID
NCT03190278
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 65 study participants
Last Updated