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Recruiting NCT04150497

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

Phase I / Phase II Interventional B-cell Acute Lymphoblastic Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: UCART22, CLLS52.
Who it may be relevant to
Registry conditions: B-cell Acute Lymphoblastic Leukemia. Basic parameters: 15 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

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)

Interventions

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

Primary outcome measures

  • Incidence of AE/SAE/DLT [Safety and Tolerability] [Time frame: 24 Months]
  • Dose escalation part: Occurrence of Dose Limiting Toxicities (DLTs) [Time frame: Up to D28 post initial UCART22 infusion]
Secondary outcome measures (5)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 14 centers
  • University of California, Los Angeles (UCLA) - Medical Center — Los Angeles
  • University of Colorado - Aurora Cancer Center — Aurora
  • Sarah Cannon - Colorado Blood Cancer Institute — Denver
  • University of Chicago — Chicago
  • Dana Farber Cancer Institute — Boston
  • Roswell Park Comprehensive Cancer Center — Buffalo
  • Memorial Sloan Kettering Cancer Center (MSKCC) David H. Koch Center for Cancer Care at Mem — New York
  • Weill Medical College of Cornell University — New York
  • … and 6 more centers
France · 5 centers
  • CHU de Nantes - Hôtel-Dieu — Nantes
  • Hôpital Saint Louis, Unité d'Hématologie Adolescents et Jeunes Adultes Département d'Hémat — Paris
  • Hôpital Robert Debré - Service d'hémato-immunologie — Paris
  • Hôpital Lyon Sud — Pierre-Bénite
  • CHU Rennes - Hopital Pontchaillou — Rennes

Identifiers

NCT: NCT04150497 · UCART22_01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗