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

Phase 2RecruitingNCT04150497

Cellectis S.A.52 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

B-cell Acute Lymphoblastic Leukemia

Interventions

UCART22BIOLOGICAL

Allogeneic engineered T-cells expressing anti-CD22 Chimeric Antigen Receptor given following a lymphodepleting regimen

CLLS52BIOLOGICAL

A monoclonal antibody that recognizes a CD52 antigen

Eligibility

Sex: ALLMin age: 15 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (19)

University of California, Los Angeles (UCLA) - Medical Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

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

Time frame: 24 Months

Dose escalation part: Occurrence of Dose Limiting Toxicities (DLTs)

Time frame: Up to D28 post initial UCART22 infusion

Secondary Outcomes

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

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

Pharmacokinetic (PK) profile/exposure levels of CLLS52 (Alemtuzumab) used during lymphodepletion

Time frame: Lymphodepletion to Day 56

Central Contacts

Cellectis Central Contact

CONTACT

+1 (347) 752-4044 clinicaltrials@cellectis.com

Data from ClinicalTrials.gov

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