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Phase 1 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 : June 10, 2021
Sponsor:
Information provided by (Responsible Party):
Cellectis S.A.

Tracking Information
First Submitted Date  ICMJE November 1, 2019
First Posted Date  ICMJE November 4, 2019
Last Update Posted Date June 10, 2021
Actual Study Start Date  ICMJE October 14, 2019
Estimated Primary Completion Date October 14, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2021)
  • 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
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 1, 2019)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2021)
  • 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 ]
  • 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 ]
  • 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 ]
  • Overall Survival [ Time Frame: From the first day of study treatment to the date of death from any cause, assessed up to Month 24 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
Official Title  ICMJE 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)
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE B-cell Acute Lymphoblastic Leukemia
Intervention  ICMJE Biological: UCART22
Allogeneic engineered T-cells expressing anti-CD22 Chimeric Antigen Receptor given following a lymphodepleting regimen
Study Arms  ICMJE 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

Intervention: Biological: UCART22
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 1, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 14, 2022
Estimated Primary Completion Date October 14, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cellectis Central Contact +1 (347) 579-0635 clinicaltrials@cellectis.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04150497
Other Study ID Numbers  ICMJE UCART22_01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cellectis S.A.
Study Sponsor  ICMJE Cellectis S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nitin Jain, MD M.D. Anderson Cancer Center
PRS Account Cellectis S.A.
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP