Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)

a study on Acute Lymphoblastic Leukemia B-Cell Acute Lymphoblastic Leukemia Leukemia Lymphoma

Summary

Eligibility
for people ages 15-70 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by Gary J. Schiller, MD
Headshot of Gary J. Schiller
Gary J. Schiller

Description

Summary

This is a 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, Lymphoid Leukemia, Alemtuzumab, UCART22, CLLS52

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
  • Sarah Cannon - Colorado Blood Cancer Institute accepting new patients
    Denver Colorado 80218 United States

Lead Scientist at UCLA

  • Gary J. Schiller, MD
    Professor-in-Residence, Medicine. Authored (or co-authored) 163 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Cellectis S.A.
Links
Sign up for this study
ID
NCT04150497
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 40 study participants
Last Updated
Contact us about this trial