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Trial record 1 of 1 for:    UCART22
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Phase I Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)

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ClinicalTrials.gov Identifier: NCT04150497
Recruitment Status : Recruiting
First Posted : November 4, 2019
Last Update Posted : November 4, 2019
Sponsor:
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 : 30 participants
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 17, 2019
Estimated Primary Completion Date : October 17, 2021
Estimated Study Completion Date : October 17, 2021


Arm Intervention/treatment
Experimental: Dose Escalation

Part 1: Dose Escalation One administration of UCART22 in the dose escalation phase will explore 4 doses of UCART22 and continue until the Maximum Tolerated Dose (MTD) is identified.

Part 2: Dose Expansion One administration of UCART22 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 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT04150497


Contacts
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Contact: Cellectis Central Contact +1 (347) 579-0635 clinicaltrials@cellectis.com

Locations
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United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Cellectis S.A.
Investigators
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Principal Investigator: Nitin Jain, MD M.D. Anderson Cancer Center

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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: November 4, 2019
Last Verified: November 2019

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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.:
BALLI-01
B-cell Acute Lymphoblastic Leukemia (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