Health Trials

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

ConditionB-cell Acute Lymphoblastic Leukemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age15-50
SponsorCellectis S.A.

About this trial

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)

Eligibility criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • UCART22
  • CLLS52

Treatment groups

52 Participants
are divided into 1 treatment group

Sponsors and collaborators

Cellectis S.A.

Lead sponsor

Source ClinicalTrials.gov