Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)

B-cell Acute Lymphoblastic Leukemia Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04150497
• Other study ID #: UCART22_01
• Status: Recruiting
• Phase: Phase 1
• Start date: October 14, 2019
• Est. completion date: January 31, 2026

Study information

• Verified date: September 2023
• Source: Cellectis S.A.
• Contact: Cellectis Central Contact
• Phone: +1 (347) 752-4044
• Email: clinicaltrials[@]cellectis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 31, 2026
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• B-cell Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Biological:
• UCART22
Allogeneic engineered T-cells expressing anti-CD22 Chimeric Antigen Receptor given following a lymphodepleting regimen
• CLLS52
A monoclonal antibody that recognizes a CD52 antigen

Locations

Country	Name	City	State
France	CHU de Nantes - Hôtel-Dieu	Nantes
France	Hôpital Robert Debré - Service d'hémato-immunologie	Paris
France	Hôpital Saint Louis, Unité d'Hématologie Adolescents et Jeunes Adultes Département d'Hématologie	Paris
France	Hôpital Lyon Sud	Pierre-Benite
France	CHU Rennes - Hopital Pontchaillou	Rennes
United States	University of Colorado - Aurora Cancer Center	Aurora	Colorado
United States	Sarah Cannon - St. David's South Austin Medical Center	Austin	Texas
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	University of Chicago	Chicago	Illinois
United States	Sarah Cannon - Colorado Blood Cancer Institute	Denver	Colorado
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of California, Los Angeles (UCLA) - Medical Center	Los Angeles	California
United States	Sarah Cannon - HCA Research Institute	Nashville	Tennessee
United States	Memorial Sloan Kettering Cancer Center (MSKCC) David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center	New York	New York
United States	Weill Medical College of Cornell University	New York	New York
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Sarah Cannon - Texas Transplant Institute at Methodist Hospital	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Cellectis S.A.

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 Months
Primary	Dose escalation part: Occurrence of Dose Limiting Toxicities (DLTs)		Up to D28 post initial UCART22 infusion
Secondary	Investigator assessed overall response rate according to the Response criteria for Acute Lymphoblastic Leukemia (ALL)		At Day 28, Day 56, Day 84, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and Month 24
Secondary	Duration of Response		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
Secondary	Progression Free Survival		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
Secondary	Overall Survival		From the first day of study treatment to the date of death from any cause, assessed up to Month 24
Secondary	Pharmacokinetic (PK) profile/exposure levels of CLLS52 (Alemtuzumab) used during lymphodepletion		Lymphodepletion to Day 56