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

Официальное название

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)

Обзор

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)

Вмешательства

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

Первичные конечные точки

• Incidence of AE/SAE/DLT [Safety and Tolerability] [Срок оценки: 24 Months]
• Dose escalation part: Occurrence of Dose Limiting Toxicities (DLTs) [Срок оценки: Up to D28 post initial UCART22 infusion]

Вторичные конечные точки (5)

• Investigator assessed overall response rate according to the Response criteria for Acute Lymphoblastic Leukemia (ALL) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Lymphodepletion to Day 56]

Критерии участия

Критерии включения

• 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

Критерии исключения

-Prior cellular therapy or investigational cellular or gene therapy within 90 days prior to enrollment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 14 центров

• 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
• … и ещё 6 центров

Франция · 5 центров

• 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

Идентификаторы

NCT: NCT04150497 · UCART22_01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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