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UCART22

Phase 1

B-cell Acute Lymphoblastic Leukemia | Monoclonal antibody | Oncology |Cellectis S.A.|Last Updated: Sep 9, 2025

Success Probability
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment52
FDA Designations
ORPHAN_DRUG
Clinical trial landscape

UCART22 · 1 trial · 1 indication

Phase 1 1
NCT04150497Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)B-cell Acute Lymphoblastic Leukemia
RECRUITING52 Analytics
PHASE1RECRUITING
Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
B-cell Acute Lymphoblastic Leukemia
NCT0415049752
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Study Endpoints
Primary Endpoints
Incidence of AE/SAE/DLT [Safety and Tolerability]
24 Months

Incidence, nature, and severity of adverse events and serious adverse events (SAEs) throughout the study in relation to UCART22 and/or lymphodepletion

Dose escalation part: Occurrence of Dose Limiting Toxicities (DLTs)
Up to D28 post initial UCART22 infusion
Secondary Endpoints
Investigator assessed overall response rate according to the Response criteria for Acute Lymphoblastic Leukemia (ALL)
At Day 28, Day 56, Day 84, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and Month 24
Duration of Response
From the date of the initial response to the date of disease progression or death from any cause, whichever occurs first, assessed up to Month 24
Progression Free Survival
From the first day of study treatment to the date of disease progression or death from any cause, whichever occurs first, assessed up to Month 24
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose EscalationEXPERIMENTALSeveral tested doses of UCART22 until the Maximum Tolerated Dose (MTD) is identified and establish Recommended Phase 2 Dose (RP2D) Dose Expansion: UCART22 administered at the RP2D
Interventions
NameTypeDescription
UCART22BIOLOGICALAllogeneic engineered T-cells expressing anti-CD22 Chimeric Antigen Receptor given following a lymphodepleting regimen
CLLS52BIOLOGICALA monoclonal antibody that recognizes a CD52 antigen
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Eligibility Criteria
Age Range15 Years to 50 Years
SexALL
Healthy VolunteersNo
Study Sites19

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 ...

Countries:United StatesFrance
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04150497primaryCompletionDate: changed
LOWMay 24, 2026NCT04150497studyFirstPostDate: changed