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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04150497
Recruitment Status : Recruiting
First Posted : November 4, 2019
Last Update Posted : September 25, 2023
Information provided by (Responsible Party):
Cellectis S.A.

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
B-cell Acute Lymphoblastic Leukemia Biological: UCART22 Biological: CLLS52 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : October 14, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : January 31, 2026

Arm Intervention/treatment
Experimental: Dose Escalation

Several 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

Biological: UCART22
Allogeneic engineered T-cells expressing anti-CD22 Chimeric Antigen Receptor given following a lymphodepleting regimen

Biological: CLLS52
A monoclonal antibody that recognizes a CD52 antigen
Other Name: Alemtuzumab

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 60 days prior to enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04150497

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Contact: Cellectis Central Contact +1 (347) 752-4044

Show Show 17 study locations
Sponsors and Collaborators
Cellectis S.A.
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Principal Investigator: Nitin Jain, MD M.D. Anderson Cancer Center
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Responsible Party: Cellectis S.A. Identifier: NCT04150497    
Other Study ID Numbers: UCART22_01
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: September 25, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cellectis S.A.:
B-cell Acute Lymphoblastic Leukemia (B-ALL)
Relapse/Refractory B-ALL
Universal Chimeric Antigen Receptor T-Cell (UCAR-T) Therapy
Transcription Activator-Like Effector Nuclease (TALEN®)
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents