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 UCLA
Dates
study started
completion around
Principal Investigator
by Gary Schiller (ucla)

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 University of California Health

  • Gary Schiller (ucla)
    Professor-in-Residence, Medicine. Authored (or co-authored) 154 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Cellectis S.A.
ID
NCT04150497
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 40 study participants
Last Updated