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Phase 1 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.
 
ClinicalTrials.gov Identifier: NCT04150497
Recruitment Status : Recruiting
First Posted : November 4, 2019
Last Update Posted : May 19, 2022
Sponsor:
Information provided by (Responsible Party):
Cellectis S.A.

Study Description
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Brief Summary:
This is a Phase 1, 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 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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 : July 31, 2023
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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

  2. For Dose Expansion: confirmation of the RP2D in patients with R/R B-ALL who have failed a CD19 directed therapy [ Time Frame: 24 Months ]

Secondary Outcome Measures :
  1. Response Assessment determined using the response criteria as defined in NCCN guidelines version 1.2020 for Acute Lymphoblastic Leukemia [ 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 ]

Eligibility Criteria
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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
Criteria

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

Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT04150497


Contacts
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Contact: Cellectis Central Contact +1 (347) 752-4044 clinicaltrials@cellectis.com

Locations
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United States, California
University of California, Los Angeles (UCLA) - Medical Center Recruiting
Los Angeles, California, United States, 90095
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60647
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, New York
Memorial Sloan Kettering Cancer Center (MSKCC) David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Weill Medical College of Cornell University Withdrawn
New York, New York, United States, 10065
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
France
Hôpital Robert Debré - Service d'hémato-immunologie Recruiting
Paris, France, 75935
Hôpital Saint Louis, Unité d'Hématologie Adolescents et Jeunes Adultes Département d'Hématologie Recruiting
Paris, France, 75935
Sponsors and Collaborators
Cellectis S.A.
Investigators
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Principal Investigator: Nitin Jain, MD M.D. Anderson Cancer Center
More Information
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Responsible Party: Cellectis S.A.
ClinicalTrials.gov Identifier: NCT04150497    
Other Study ID Numbers: UCART22_01
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: May 19, 2022
Last Verified: May 2022
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
Allogeneic
Transcription Activator-Like Effector Nuclease (TALEN®)
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases