Open Actively Recruiting

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

About

Brief 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)

Primary Purpose
The main objective of the intervention(s) being evaluated by the clinical trial. Learn more
Treatment
Study Type
The nature of the investigation or investigational use for which clinical study information is being submitted. Learn more
Interventional
Phase
Phase 1

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
15 Years
Maximum Age
50 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 90 days prior to enrollment

Join this Trial

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Study Stats
Protocol No.
20-001086
Category
Adolescent & Young Adults (AYA)
Leukemia
Principal Investigator
Contact
  • Bruck Habtemariam
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04150497
For detailed technical eligibility, visit ClinicalTrials.gov.