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Phase I 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 : May 28, 2020
Information provided by (Responsible Party):
Cellectis S.A.

Brief Summary:
This is a Phase I, 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, tolerance, clinical activity of UCART22 and to determine the Maximum Tolerated Dose (MTD).

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I, 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 : October 14, 2022
Estimated Study Completion Date : October 14, 2022

Arm Intervention/treatment
Experimental: Dose Escalation

Several tested doses of UCART22 until the Maximum Tolerated Dose (MTD) is identified

Dose Expansion: UCART22 administered at the MTD

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Relapsed or refractory CD22-positive acute lymphoblastic leukemia (ALL) after at least one standard chemotherapy regimen and one salvage regimen
  2. Eastern Cooperative Oncology Group performance status of 0 or 1
  3. No organ dysfunction that in the opinion of the investigator precludes intensive induction chemotherapy or cellular therapy

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) 579-0635

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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60647
United States, New York
Weill Medical College of Cornell University Recruiting
New York, New York, United States, 10065
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
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: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases