Summary

Eligibility
for people ages 15-70 (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

This is a Phase 1, first-in-human, open-label, dose escalation and expansion study of UCART22 administered intravenously to patients with relapsed or refractory B-cell acute Lymphoblastic Leukemia (B-ALL). The purpose of this study is to evaluate the safety and clinical activity of UCART22 and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)

Official Title

Open Label Dose-escalation and Dose-expansion Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of UCART22 (Allogeneic Engineered T-cells Expressing Anti-CD22 Chimeric Antigen Receptor) in Patients With Relapsed or refractoryCD22+ B-cell Acute Lymphoblastic Leukemia (B-ALL)

Keywords

B-cell Acute Lymphoblastic Leukemia B-cell Acute Lymphoblastic Leukemia (B-ALL) Relapse/Refractory B-ALL Universal Chimeric Antigen Receptor T-Cell (UCAR-T) Therapy Allogeneic Transcription Activator-Like Effector Nuclease (TALEN®) Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid UCART22 Dose Escalation

Eligibility

You can join if…

Open to people ages 15-70

B-ALL blast cells expressing CD22 Diagnosed with R/R B-ALL prior therapy must include at least one standard chemotherapy regimen and at least one salvage regimen

You CAN'T join if...

Prior cellular therapy or investigational cellular or gene therapy within 60 days prior to enrollment

Locations

  • University of California, Los Angeles (UCLA) - Medical Center accepting new patients
    Los Angeles California 90095 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
NCT04150497
Phase
Phase 1
Study Type
Interventional
Last Updated