Back to resultsPhase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
Primary Purpose
B-cell Acute Lymphoblastic Leukemia
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
UCART22
CLLS52
Sponsored by
About this trial
This is an interventional treatment trial for B-cell Acute Lymphoblastic Leukemia focused on measuring 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®)
Eligibility 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
Sites / Locations
- University of California, Los Angeles (UCLA) - Medical CenterRecruiting
- University of Colorado - Aurora Cancer CenterRecruiting
- Sarah Cannon - Colorado Blood Cancer InstituteRecruiting
- University of ChicagoRecruiting
- Dana Farber Cancer InstituteRecruiting
- Memorial Sloan Kettering Cancer Center (MSKCC) David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterRecruiting
- Weill Medical College of Cornell University
- Children's Hospital of PhiladelphiaRecruiting
- Sarah Cannon - HCA Research InstituteRecruiting
- Sarah Cannon - St. David's South Austin Medical CenterRecruiting
- MD Anderson Cancer CenterRecruiting
- Sarah Cannon - Texas Transplant Institute at Methodist HospitalRecruiting
- CHU de Nantes - Hôtel-DieuRecruiting
- Hôpital Saint Louis, Unité d'Hématologie Adolescents et Jeunes Adultes Département d'HématologieRecruiting
- Hôpital Robert Debré - Service d'hémato-immunologieRecruiting
- Hôpital Lyon SudRecruiting
- CHU Rennes - Hopital PontchaillouRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dose Escalation
Arm Description
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
Outcomes
Primary Outcome Measures
Incidence of AE/SAE/DLT [Safety and Tolerability]
Incidence, nature, and severity of adverse events and serious adverse events (SAEs) throughout the study in relation to UCART22 and/or lymphodepletion
Dose escalation part: Occurrence of Dose Limiting Toxicities (DLTs)
Secondary Outcome Measures
Investigator assessed overall response rate according to the Response criteria for Acute Lymphoblastic Leukemia (ALL)
Duration of Response
Progression Free Survival
Overall Survival
Pharmacokinetic (PK) profile/exposure levels of CLLS52 (Alemtuzumab) used during lymphodepletion
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04150497
Brief Title
Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 14, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cellectis S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Acute Lymphoblastic Leukemia
Keywords
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®)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose Escalation
Arm Type
Experimental
Arm Description
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 Type
Biological
Intervention Name(s)
UCART22
Intervention Description
Allogeneic engineered T-cells expressing anti-CD22 Chimeric Antigen Receptor given following a lymphodepleting regimen
Intervention Type
Biological
Intervention Name(s)
CLLS52
Other Intervention Name(s)
Alemtuzumab
Intervention Description
A monoclonal antibody that recognizes a CD52 antigen
Primary Outcome Measure Information:
Title
Incidence of AE/SAE/DLT [Safety and Tolerability]
Description
Incidence, nature, and severity of adverse events and serious adverse events (SAEs) throughout the study in relation to UCART22 and/or lymphodepletion
Time Frame
24 Months
Title
Dose escalation part: Occurrence of Dose Limiting Toxicities (DLTs)
Time Frame
Up to D28 post initial UCART22 infusion
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Overall Survival
Time Frame
From the first day of study treatment to the date of death from any cause, assessed up to Month 24
Title
Pharmacokinetic (PK) profile/exposure levels of CLLS52 (Alemtuzumab) used during lymphodepletion
Time Frame
Lymphodepletion to Day 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cellectis Central Contact
Phone
+1 (347) 752-4044
Email
clinicaltrials@cellectis.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nitin Jain, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles (UCLA) - Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Colorado - Aurora Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarah Cannon - Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60647
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center (MSKCC) David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Withdrawn
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarah Cannon - HCA Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarah Cannon - St. David's South Austin Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States
Individual Site Status
Recruiting
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarah Cannon - Texas Transplant Institute at Methodist Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
CHU de Nantes - Hôtel-Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Saint Louis, Unité d'Hématologie Adolescents et Jeunes Adultes Département d'Hématologie
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Robert Debré - Service d'hémato-immunologie
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Lyon Sud
City
Pierre-Benite
ZIP/Postal Code
69310
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Rennes - Hopital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
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