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NCT Number: NCT04150497

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

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)

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Key information

Conditions

B-cell Acute Lymphoblastic Leukemia Burkitt Lymphoma DNA Virus Infections Disease Attributes Epstein-Barr Virus Infections Hemic and Lymphatic Diseases Herpesviridae Infections Immune System Diseases Immunoproliferative Disorders Infections Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Tumor Virus Infections Virus Diseases

Age range

15 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

CHU de Nantes - Hôtel-Dieu, Nantes, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UCART22

Biological

Allogeneic engineered T-cells expressing anti-CD22 Chimeric Antigen Receptor given following a lymphodepleting regimen

CLLS52

Biological

A monoclonal antibody that recognizes a CD52 antigen

Other names: Alemtuzumab

Primary outcomes

  1. Incidence of AE/SAE/DLT [Safety and Tolerability]

    Time frame: 24 Months

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

  2. Dose escalation part: Occurrence of Dose Limiting Toxicities (DLTs)

    Time frame: Up to D28 post initial UCART22 infusion

Secondary outcomes

  1. Investigator assessed overall response rate according to the Response criteria for Acute Lymphoblastic Leukemia (ALL)

    Time frame: At Day 28, Day 56, Day 84, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and Month 24

  2. Duration of Response

    Time frame: 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

  3. Progression Free Survival

    Time frame: 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

  4. Overall Survival

    Time frame: From the first day of study treatment to the date of death from any cause, assessed up to Month 24

  5. Pharmacokinetic (PK) profile/exposure levels of CLLS52 (Alemtuzumab) used during lymphodepletion

    Time frame: Lymphodepletion to Day 56

Study contacts

Contact information is provided by the study sponsor or research team.

Cellectis Central Contact

CONTACT

[email protected]

+1 (347) 752-4044

Sponsors and collaborators

Lead sponsor

Cellectis S.A.

Industry

Registry information

Official study title

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)

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Nov 4, 2019
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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