Clinical trial NCT04150497: 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
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: 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®)
Lead sponsor: Cellectis S.A.
Sponsor class: INDUSTRY
First posted: 2019-11-04
Enrollment: 52
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


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 90 days prior to enrollment

Primary outcomes:
measure: Incidence of AE/SAE/DLT [Safety and Tolerability]
timeFrame: 24 Months
measure: Dose escalation part: Occurrence of Dose Limiting Toxicities (DLTs)
timeFrame: Up to D28 post initial UCART22 infusion
Secondary outcomes:
measure: Investigator assessed overall response rate according to the Response criteria for Acute Lymphoblastic Leukemia (ALL)
timeFrame: At Day 28, Day 56, Day 84, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and Month 24
measure: Duration of Response
timeFrame: 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
measure: Progression Free Survival
timeFrame: 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
measure: Overall Survival
timeFrame: From the first day of study treatment to the date of death from any cause, assessed up to Month 24
measure: Pharmacokinetic (PK) profile/exposure levels of CLLS52 (Alemtuzumab) used during lymphodepletion
timeFrame: Lymphodepletion to Day 56
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles (UCLA) - Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado - Aurora Cancer Center
state: Colorado
city: Denver
country: United States
facility: Sarah Cannon - Colorado Blood Cancer Institute
state: Colorado
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (MSKCC) David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon - HCA Research Institute
state: Tennessee
city: Austin
country: United States
facility: Sarah Cannon - St. David's South Austin Medical Center
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Sarah Cannon - Texas Transplant Institute at Methodist Hospital
state: Texas
city: Nantes
country: France
facility: CHU de Nantes - Hôtel-Dieu
city: Paris
country: France
facility: Hôpital Saint Louis, Unité d'Hématologie Adolescents et Jeunes Adultes Département d'Hématologie
city: Paris
country: France
facility: Hôpital Robert Debré - Service d'hémato-immunologie
city: Pierre-Benite
country: France
facility: Hôpital Lyon Sud
city: Rennes
country: France
facility: CHU Rennes - Hopital Pontchaillou
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Nitin Jain, MD
role: PRINCIPAL_INVESTIGATOR
References: