Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
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Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
52estimated
Sites
19
Countries
France, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2019-10-14 | actual | When the study began enrolling |
| Primary completion | 2026-06-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-06-30 | estimated | The whole study's end, after follow-up |
| First posted | 2019-11-04 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-09-09 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- B-cell Acute Lymphoblastic Leukemia
Interventions
- Biological: UCART22
- Biological: CLLS52 — also filed as Alemtuzumab
Primary outcomes
what the primary-completion date above is the date OFIncidence of AE/SAE/DLT [Safety and Tolerability]
measured 24 Months
Dose escalation part: Occurrence of Dose Limiting Toxicities (DLTs)
measured Up to D28 post initial UCART22 infusion
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