Open Actively Recruiting

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

About

Brief 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)

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
15 Years
Maximum Age
70 Years

Inclusion Criteria:

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

Exclusion Criteria:

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

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Study Stats
Protocol No.
20-001086
Category
Hematology-Oncology
Oncology
Contact
Bruck Habtemariam
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04150497
For detailed technical eligibility, visit ClinicalTrials.gov.