Идёт набор NCT06614686

U87 CAR-T in Patients With Advanced Head and Neck Tumors

Фаза I С лечением Nasopharynx Cancer Head and Neck Cancer

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: U87 autologous CAR T-cell.
Кому может быть актуально: Состояния в реестре: Nasopharynx Cancer, Head and Neck Cancer. Базовые параметры: 18 лет — 70 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: Китай
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

A Single-arm, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of U87 in Patients With Advanced Malignant Head and Neck Tumors

Обзор

This is a single-arm, open-label clinical study to evaluate the safety, tolerability, and efficacy of U87 injection solution in patients with advanced malignant head and neck tumors.

Подробное описание

Following consent, patients must have tumor tissue evaluated by IHC assay. Patients meeting all eligibility criteria will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (U87). Following manufacture of the drug product, subjects will receive preconditioning prior to U87 infusion. All subjects will be asked to continue to undergo long-term gene safety follow-up.

Вмешательства

Препарат U87 autologous CAR T-cell
Treatment with U87 chimeric antigen receptor T-cell infusion.

Первичные конечные точки

Incidence of Adverse events after U87 CAR-T cells infusion [Safety and Tolerability] [Срок оценки: 28 days post administration of CAR-T-cells]

Вторичные конечные точки (9)

Pharmacokinetics of U87 CAR-T cells [Срок оценки: 2 years post CAR T cell infusion]
Pharmacokinetics of U87 CAR-T cells [Срок оценки: 2 years post CAR T cell infusion]
Pharmacokinetics of U87 CAR-T cells [Срок оценки: 2 years post CAR T cell infusion]
Pharmacodynamics of U87 CAR-T cells [Срок оценки: 2 years post CAR T cell infusion]
Objective Response Rate (ORR), as assessed by Investigators [Срок оценки: 2 years post CAR T cell infusion]
Duration of response (DOR), as assessed by Investigators [Срок оценки: 2 years post CAR T cell infusion]
Overall survival (OS) [Срок оценки: 2 years post CAR T cell infusion]
Progression-free survival (PFS), as assessed by Investigators [Срок оценки: 2 years post CAR T cell infusion]
Disease control rate (DCR), as assessed by Investigators [Срок оценки: 2 years post CAR T cell infusion]

Критерии участия

Критерии включения

Subjects have provided informed consent, understanding the study\&#39;s risks and benefits, and are willing to complete the study procedures.
Age between 18 and 70 years old at the time of consent, inclusive, and open to both genders.
ECOG performance status of 0-1.
Anticipated survival of at least 12 weeks.
Histologically or cytologically confirmed advanced malignant head and neck cancer patients with no effective standard treatments available
Positive Trop2 expression (intensity ≥2+, expression rate ≥40%) in tumor tissue samples within 2 years prior to consent or from recent biopsies.
At least one measurable tumor lesion according to RECIST 1.1.
Suitable venous access for mononuclear cell collection.
Adequate major organ function.
Negative pregnancy test for women of reproductive age at screening; sexually active subjects must agree to use effective contraception during the study and for one year after the last CAR-T cell infusion.

Критерии исключения

Inadequate washout period from prior anti-cancer treatments before leukapheresis.
Receipt of live or attenuated vaccines within 4 weeks prior to leukapheresis or planned receipt during the study.
Major surgery or significant trauma within 4 weeks prior to leukapheresis or planned during the study.
Previous Trop2-targeted CAR-T/TCR-T cell therapy or other cellular treatments, or therapeutic cancer vaccines.
Symptomatic brain metastases or leptomeningeal metastases deemed ineligible by the investigator.
Active infection requiring intravenous anti-infective therapy.
Positive for HBsAg, HBeAg, HBV-DNA, HCV-Ab, HCV-RNA, TP-Ab, HIV antibodies, or elevated EBV-DNA, CMV-DNA.
Primary immunodeficiency or active autoimmune disease.
Chronic use of systemic corticosteroids or immunosuppressants within 7 days before leukapheresis, except for local, ophthalmic, intra-articular, intranasal, or inhaled treatments.
Prior treatment-related adverse effects not recovered to CTCAE v5.0 grade ≤1 or specified levels, except for non-safety risk toxicities.
History of interstitial lung disease, interstitial pneumonia, pulmonary inflammation, or extensive thoracic radiotherapy.
Allergy to protein drugs or multiple medications.
Other untreated malignancies within 5 years prior to study drug use. History of immune deficiency, hematopoietic stem cell/organ transplantation. Uncontrollable third-space fluid accumulation.
Severe cardiovascular or cerebrovascular disease history, including NYHA class ≥II heart failure, uncontrolled hypertension, or recent severe events.

Pregnant or breastfeeding women.