First-in-human Study of a New Treatment (4A10) for Patients With Relapsed or Hard-to-treat Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma, Focused on Safety and How the Drug Behaves in the Body and Early Signs of Effect.

Официальное название

A First in Human, Phase 1, Open-Label Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 4A10 Monotherapy In Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Обзор

ALT-101 is a first-in-human Phase 1 clinical trial testing a new antibody drug called 4A10 in patients with relapsed or hard-to-treat acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma. 4A10 is a targeted therapy designed to recognize and attach to a specific protein (CD127) found on leukemia cells. Once it binds, it works in two ways: it blocks growth signals that help cancer cells survive, and it helps the immune system find and destroy those cancer cells. In this study, patients receive 4A10 through an intravenous (IV) infusion once a week. The main goal of the trial is to find out if the drug is safe, what dose can be given, and how the body processes it. Researchers will also look for early signs that the treatment may be working. The study starts with small groups of patients receiving increasing doses to carefully monitor safety. Each patient is closely observed during the first treatment cycle (about 4-6 weeks) to watch for side effects. If the treatment is helping and is well tolerated, patients may continue treatment for up to six cycles. Overall, this study is an early step in testing a new, targeted immune-based therapy for difficult-to-treat blood cancers.

Вмешательства

• Препарат 4A10
  4A10 (Molecule B4532) is an investigational human Immunoglobulin G Subclass 1 (IgG1) monoclonal antibody that specifically binds CD127 (Interleukin-7 receptor alpha subunit, IL-7Rα). CD127 is a component of the interleukin-7 receptor and the thymic stromal lymphopoietin receptor (TSLPR), which are expressed on T-cell acute lymphoblastic leukemia (T-ALL) and pre-B-cell acute lymphoblastic leukemia (B-ALL) cells.

Первичные конечные точки

• Incidence of Treatment-Emergent Adverse Events (TEAEs) at each dose level [Срок оценки: Through study duration, an average of 1 year]
• Determine the Recommended Phase 2 Dose (RP2D)/ Recommended Dose for Expansion (RDE) of 4A10 as a single agent in patients with R/R ALL/LL. [Срок оценки: Through study duration, an average of 1 year]

Вторичные конечные точки (12)

• Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL. [Срок оценки: Through study duration, an average of 1 year]
• Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL. [Срок оценки: Through study duration, an average of 1 year]
• Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL. [Срок оценки: Through study duration, an average of 1 year]
• Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL. [Срок оценки: Through the study duration, an average of 1 year.]
• Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL. [Срок оценки: Through the study duration, an average of 1 year]
• Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL. [Срок оценки: Through the study duration, an average of 1 year]
• Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL. [Срок оценки: Through the study duration, an average of 1 year]
• Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL. [Срок оценки: Through study duration, an average of 1 year.]
• Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL. [Срок оценки: Through study duration, an average of 1 year]
• Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL. [Срок оценки: Through study duration, an average of 1 year]
• Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL. [Срок оценки: Through study duration, an average of 1 year]
• Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL. [Срок оценки: Through study duration, an average of 1 year]

Критерии участия

Критерии включения

• Confirmed diagnosis of T/B-ALL or T/B-LL
• Relapsed or refractory disease without curative options
• Adequate organ function and performance status

Критерии исключения

• Patients with CNS3 disease
• Patients with DNA fragility syndromes (e.g., Fanconi, Bloom), trisomy 21 (Down Syndrome)
• Prior exposure to anti-CD127 therapies
• Uncontrolled infections

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 · 5 центров

• Children's Hospital Colorado — Aurora
• Memorial Sloan Kettering Cancer Center — New York
• Children's Hospital of Philadelphia — Philadelphia
• Cook Children's Medical Center — Fort Worth
• Texas Children's Hospital — Houston

Идентификаторы

NCT: NCT07586618 · The ALLiance Study · 5R44CA268530-02 · DP230071

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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