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NCT04150497RecruitingPhase 1/2

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

Open Label Dose-escalation and Dose-expansion Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of UCART22 (Allogeneic Engineered T-cells Expressing Anti-CD22 Chimeric Antigen Receptor) in Patients With Relapsed or refractoryCD22+ B-cell Acute Lymphoblastic Leukemia (B-ALL)

Source: ClinicalTrials.gov · Last updated 9 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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)

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
52 (estimated)
First submitted
1 Nov 2019
Start date
14 Oct 2019
Primary completion date
30 Jun 2026
Lead sponsor
Cellectis S.A.
NCT number
NCT04150497
EU CT number
2022-502305-15-00
EudraCT number
2020-004768-24

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 52
  • From 14 Oct 2019 to the primary completion date, 30 Jun 2026
  • 42 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • -Prior cellular therapy or investigational cellular or gene therapy within 90 days prior to enrollment

Who the study is looking for

  • 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

Age in the registry: 15 years to 50 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (42)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital Sant Joan De Deu Barcelona
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Esplugues de LlobregatSpainCompleted
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainCompleted
Hospital Universitario La Paz
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MadridSpainCompleted
Clinica Universidad de Navarra
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MadridSpainCompleted
Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus
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MadridSpainCompleted
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainCompleted
Hospital Universitario De Salamanca
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SalamancaSpainCompleted
University Hospital Virgen Del Rocio S.L.
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SevillaSpainCompleted
Hospital Clinico Universitario de Valencia
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ValenciaSpainCompleted
Institut Paoli-Calmettes
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MarseilleFranceCompleted
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceCompleted
CHRU de Nancy
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NancyFranceCompleted
Centre Hospitalier Universitaire de Nantes
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NantesFranceCompleted
Centre Hospitalier Universitaire de Nice
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NiceFranceCompleted
Assistance Publique Hopitaux de Paris
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ParisFranceCompleted
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceCompleted
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceCompleted
Centre Hospitalier Universitaire de Rennes
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RennesFranceCompleted
Institut Universitaire Du Cancer Toulouse-Oncopole
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Toulouse Cedex 9FranceCompleted
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyCompleted
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyCompleted
IRCCS Istituto Giannina Gaslini
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GenoaItalyCompleted
Ospedale San Raffaele S.r.l.
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MilanItalyCompleted
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyCompleted
Azienda Ospedaliera di Perugia
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PerugiaItalyCompleted
Ospedale Pediatrico Bambino Gesù
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RomeItalyCompleted
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyCompleted
University of Colorado - Aurora Cancer Center
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AuroraUnited StatesRecruiting
Sarah Cannon - St. David's South Austin Medical Center
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AustinUnited StatesRecruiting
Dana-Farber Cancer Institute
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BostonUnited StatesRecruiting
Roswell Park Comprehensive Cancer Center
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BuffaloUnited StatesRecruiting
University of Chicago
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ChicagoUnited StatesRecruiting
Sarah Cannon-Colorado Blood Cancer Institute
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DenverUnited StatesRecruiting
MD Anderson Cancer Center
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HoustonUnited StatesRecruiting
University of California, Los Angeles (UCLA) - Medical Center
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Los AngelesUnited StatesRecruiting
University of Wisconsin Carbone Cancer Center
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MadisonUnited StatesRecruiting
Sarah Cannon - HCA Research Institute
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NashvilleUnited StatesRecruiting
Memorial Sloan Kettering Cancer Center (MSKCC) David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
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New YorkUnited StatesRecruiting
Weill Medical College of Cornell University
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New YorkUnited StatesWithdrawn
Children's Hospital of Philadelphia
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PhiladelphiaUnited StatesRecruiting
Sarah Cannon - Texas Transplant Institute at Methodist Hospital
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San AntonioUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.