A Study of Anti-BCMA CAR-T Therapy in Newly Diagnosed Myeloma Patients Who Are Transplant-ineligible

Официальное название

A Multicenter, Open-label, Single-arm Clinical Study of Anti-BCMA CAR-T Cell Therapy in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma

Обзор

This is a prospective study of anti-BCMA CAR-T in transplant-ineligible patients with newly diagnosed multiple myeloma.

Подробное описание

After the diagnosis of multiple myeloma (MM), patients were stratified by frailty status. Frail patients received 4 cycles of VRd regimen (bortezomib, lenalidomide, and dexamethasone), while non-frail patients received 4 cycles of DVRd regimen (daratumumab, bortezomib, lenalidomide, and dexamethasone). Following induction therapy, peripheral blood lymphocytes were collected to manufacture anti-BCMA CAR-T cells. After lymphodepletion with the FC regimen (fludarabine and cyclophosphamide), patients received a single infusion of anti-BCMA CAR-T cells at a target dose of 2.0 × 10\^6 CAR-positive cells per kilogram of body weight. Peripheral blood samples were collected at regular intervals to assess treatment efficacy, safety, and CAR-T cell expansion and persistence. Patients were closely monitored for 6 months post-infusion. Thereafter, disease assessments, physical examinations, and hematologic tests were conducted every 3 months for a total follow-up duration of 2 years.

Вмешательства

• Биопрепарат CAR-T
  The T cells are genetically modified to express a chimeric antigen receptor targeting BCMA and are infused after induction therapy at a target dose of ≥2.0×10\^6 cells/kg

Первичные конечные точки

• Progression-Free Survival (PFS) [Срок оценки: Up to 36 months after CAR-T infusion]
• Overall Survival (OS) [Срок оценки: Up to 36 months after CAR-T infusion]

Вторичные конечные точки (3)

• Objective Response Rate (ORR) [Срок оценки: Up to 36 months after CAR-T infusion]
• MRD [Срок оценки: Up to 36 months after CAR-T infusion]
• Adverse Events (AE) [Срок оценки: Up to 36 months after CAR-T infusion]

Критерии участия

Критерии включения

• Age between 18 and 70 years (inclusive);
• Estimated life expectancy of more than 12 weeks;
• Diagnosis of multiple myeloma confirmed by physical examination, pathological evaluation, laboratory tests, and imaging studies;
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels less than 3 times the upper limit of normal (ULN);
• Karnofsky Performance Status (KPS) score > 50%.
• Ineligible for ASCT.

Критерии исключения

• Pregnant or lactating women, or women planning to become pregnant within the next six months;
• Transduction efficiency of targeted lymphocytes <10%, or expansion fold <5× under CD3/CD28 co-stimulation, as determined by feasibility screening;
• History of severe allergies or hypersensitivity, especially to interleukin-2 (IL-2);
• Significant dysfunction of vital organs including the heart, lungs, or brain;
• Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07070960 · XYFY2025-KL280-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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