Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL

Официальное название

A Randomized, Open-label Study Evaluating the Efficacy and Safety of Cemacabtagene Ansegedleucel in Participants With Minimal Residual Disease After Response to First Line Therapy for Large B-cell Lymphoma

Обзор

This is a randomized, open-label study in adult patients who have completed standard first line therapy for large B-cell lymphoma (LBCL) and achieved a complete response or partial response suitable for observation, but who have minimal residual disease (MRD) as detected by the Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq™. The purpose of the trial is to assess the efficacy and safety of consolidation with cemacabtagene ansegedleucel (cema-cel), an allogeneic CD19 CAR T product, as compared to standard of care observation. In this study, participants with MRD are randomized 1:1 to treatment with cema-cel or an observation arm. Treatment includes cema-cel following a lymphodepletion regimen of fludarabine and cyclophosphamide. Prior to August 2025, participants may also have received an anti-CD52 monoclonal antibody, ALLO-647, as part of their lymphodepletion regimen.

Вмешательства

• Генная терапия cemacabtagene ansegedleucel
  An allogeneic CAR T cell therapy targeting CD19
• Препарат Fludarabine
  Chemotherapy for lymphodepletion
• Препарат Cyclophosphamide
  Chemotherapy for lymphodepletion
• Устройство Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™
  A diagnostic test intended to identify patients with minimal residual disease at the end of first line treatment for LBCL.

Первичные конечные точки

• Event-free survival per independent review committee assessment [Срок оценки: Up to 60 months]

Вторичные конечные точки (5)

• Progression-free survival per independent review committee assessment [Срок оценки: Up to 60 months]
• Overall survival [Срок оценки: Up to 60 months]
• Incidence and severity of adverse events and their relationship to cemacabtagene ansegedleucel and ALLO-647 [Срок оценки: Up to 60 months]
• Incidence and severity of laboratory toxicities related to cemacabtagene ansegedleucel and ALLO-647 [Срок оценки: Up to 60 months]
• Minimal residual disease clearance [Срок оценки: Up to 60 months]

Критерии участия

Критерии включения

• LBCL per WHO 2017 including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and primary mediastinal B-cell lymphoma histologically confirmed by pathology report.
• Participant has completed a full course of standard first line therapy (e.g., R-CHOP, dose-adjusted EPOCH-R, Pola-R-CHP) as intended. Participants cannot have received additional lines of therapy.
• Participant achieved CR, or PR suitable for observation, at the end of first line therapy based on PET/CT evaluation
• Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™, is positive.
• Adult participants ≥18 years of age.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
• Adequate hematological, renal, hepatic, pulmonary, and cardiac function
• Non-hematologic toxicities related to prior therapy must be recovered to baseline or grade ≤1.

Критерии исключения

• LBCL with history of central nervous system involvement, transformed from other malignancy (e.g., transformed follicular lymphoma or marginal zone lymphoma, Richter's transformation), or T-cell/histiocyte rich LBCL.
• Prior treatment with anti-CD19 targeted therapies.
• Anti-cancer treatment, including radiation, after end of treatment PET/CT and/or MRD testing is performed.
• Active and clinically significant autoimmune disease.
• Active systemic bacterial, fungal, or viral infections requiring systemic treatment.
• History of another primary malignancy or bone marrow disorder (e.g., myelofibrosis, smoldering multiple myeloma) within 3 years prior to enrollment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 62 центра

• Banner MD Anderson Cancer Center — Gilbert
• Genesis Cancer and Blood Institute — Hot Springs
• Alta Bates Summit Medical Center — Berkeley
• City of Hope — Duarte
• Cedars-Sinai Medical Center — Los Angeles
• University of California, Los Angeles — Los Angeles
• University of California, Davis Comprehensive Cancer Center — Sacramento
• University of California, San Diego — San Diego
• … и ещё 54 центра

South Korea · 8 центров

• Pusan National University Hospital — Seogu
• National Cancer Center — Goyang-si
• Chonnam National University, Hwasun Hospital — Hwasun
• Seoul National University — Seoul
• Severance Hospital, Yonsei University Health System — Seoul
• Asan Medical Center — Seoul
• … и ещё 2 центра

Австралия · 6 центров

• Icon Cancer Centre Wesley — Auchenflower
• Royal Hobart Hospital — Hobart
• Monash Health — Clayton
• St. Vincent's Hospital Melbourne — Fitzroy
• Austin Health — Heidelberg
• Hollywood Private Hospital — Nedlands

Канада · 6 центров

• Arthur JE Child Comprehensive Cancer Centre — Calgary
• Queen Elizabeth II Health Sciences Centre — Halifax
• Princess Margaret Cancer Centre - University Health Network — Toronto
• Centre Integre Universitaire de Sante et Services Sociaux de L'Est de I'lle de Montreal / — Montreal
• CHUM - University of Montreal Hospital Centre — Montreal
• Hopital de'L'Enfant-Jesus — Québec

Идентификаторы

NCT: NCT06500273 · ALLO-501A-202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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