Идёт набор NCT06090864

ATLCAR.CD30.CCR4 for CD30+ HL ATLCAR.CD30.CCR4 Cells

Фаза I / Фаза II С лечением Hodgkin Lymphoma Relapse Refractory

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Chemotherapy, Cell infusion.
Кому может быть актуально: Состояния в реестре: Hodgkin Lymphoma, Relapse, Refractory. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) and CCR4 for Relapsed/Refractory CD30+ Hodgkin s Lymphoma

Обзор

Despite the progress in the therapy, Hodgkin's Lymphoma (HL) remains fatal for more than 15% of patients. Even in patients who are cured, the morbidity of therapy is substantial and long-lasting. New therapeutic agents are required therefore not only to further reduce mortality but also to alleviate morbidity. The majority of HL express the CD30 antigens. CD30 expression is routinely used for the diagnosis of HL. Preclinical observations support CD30 as a viable target of CAR-T therapy. This phase Ib/II study was conducted based on these observations. The purpose of this study is to determine the tolerability of ATLCAR.CD30.CCR4 cells in subjects with Hodgkin's Lymphoma and identify a recommended dose for further. This is a single-center, open-label phase Ib/II trial that uses a 3+3 design to identify a recommended phase 2 dose (RP2D) of ATLCAR.CD30.CCR4 cells in Hodgkin's Lymphoma. The phase II portion is designed to determine the PFS of ATLCAR.CD30.CCR4 in Hodgkin's Lymphoma. Subjects will be enrolled on 1 of 3 dose levels as determined by a 3+3 design. Up to 25 evaluable subjects may then be enrolled in the phase II portion of the study. Subjects may have cells procured to manufacture the ATLCAR.CD30.CCR4 cells if they meet eligibility for procurement. During the time period necessary to manufacture the ATLCAR.CD30.CCR4 cells, Subjects will be allowed to receive standard-of-care bridging therapy at the discretion of their local oncologist. Prior to cell infusion, subjects will undergo additional eligibility evaluations, and then if eligible, will undergo lymphodepletion followed by cell infusion 2-14 days later. Subjects will then be followed for 15 years as is required for studies involving gene transfer experiments.

Вмешательства

Препарат Chemotherapy
Subjects will receive a lymphodepletion regimen of bendamustine 70 mg/m2 IV and fludarabine 30 mg/m2 each as a daily infusion for 3 consecutive days prior to the ATLCAR.CD30.CCR4 cell infusion.
Биопрепарат Cell infusion
ATLCAR.CD30.CCR4 cells infusion for the eligible subjects after depletion chemotherapy.

Первичные конечные точки

Phase 1b adverse events [Срок оценки: Up to 6 weeks]
Phase 1b Toxicity Cytokine Release Syndrome (CRS) [Срок оценки: Up to 6 weeks]
Phase 1b Toxicity Immune effector cell-associated neurotoxicity syndrome (ICANS) [Срок оценки: Up to 6 weeks]
Phase II Median Progression Free Survival (PFS) [Срок оценки: Up to 6 months]

Вторичные конечные точки (3)

Phase Ib Dose Limiting Toxicity [Срок оценки: Up to 6 weeks]
Overall Survival (OS) [Срок оценки: Up to 6 months]
Duration of Response (DOR) [Срок оценки: Up to 6 months]

Критерии участия

During the period of cell procurement and lymphodepletion, subjects will be eligible to receive standard-of-care therapy e.g., chemotherapy or radiation therapy to stabilize their disease if the treating physician feels it is in the subject's best interests. Eligibility must be maintained up until the subject is procured, receives lymphodepletion, or receives treatment for the subject to be considered eligible to proceed with the specific phase of the study.

Критерии включения

Unless otherwise noted, subjects must meet all of the following criteria to participate in all phases of the study. As these criteria are unchanging they will be evaluated at the time of initial enrollment and not continuously throughout the study.

Written informed consent and HIPAA authorization for release of personal health information explained to, understood by, and signed by the subject or legally authorized representative.
Age ≥ 18 years at the time of consent.
Karnofsky score of > 60%
The subject must have a diagnosis of Classical Hodgkin Lymphoma according to World Health Organization criteria.