A Study of Humanized BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma

Официальное название

Clinical Trial for the Safety and Efficacy of Humanized BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma

Обзор

Clinical Trial for the safety and efficacy of humanized BCMA-targeted CAR-T cells therapy for refractory/relapsed multiple myeloma

Подробное описание

This is a single arm, open-label, single-center study. This study is indicated for relapsed BCMA+ multiple myeloma, the selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 50 patients will be enrolled for this trial. Primary objective is to explore the safety, main consideration is dose-related safety.

Вмешательства

• Препарат BCMA Targeted CAR T-cells
  Each subject receive BCMA Targeted CAR T-cells by intravenous infusion

Первичные конечные точки

• Dose-limiting toxicity (DLT) [Срок оценки: Baseline up to 28 days after BCMA targeted CAR T-cells infusion]
• Incidence of treatment-emergent adverse events (TEAEs) [Срок оценки: Up to 2 years after BCMA targeted CAR T-cells infusion]

Вторичные конечные точки (6)

• Overall response rate (ORR) [Срок оценки: At Day 28]
• Overall survival (OS) [Срок оценки: At Month 6, 12, 24]
• Quality of life(EORTC QLQ-C30) Core 30 (EORTC QLQ-C30) [Срок оценки: At Baseline, Month 1, 3, 6, 9 and 12]
• Instrumental Activities of Daily Living (IADL) score [Срок оценки: At Baseline, Month 1, 3, 6, 9 and 12]
• Activities of Daily Living (ADL) score [Срок оценки: At Baseline, Month 1, 3, 6, 9 and 12]
• Hospital Anxiety and Depression Scale (HADS) score [Срок оценки: At Baseline, Month 1, 3, 6, 9 and 12]

Критерии участия

Критерии включения

• Histologically confirmed diagnosis of multiple myeloma (MM):

• Patients with BCMA positive relapsed/refractory MM;
• Relapsed after hematopoietic stem cell transplantation;
• Cases with recurrent positive minimal residual disease;
• Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.
• Anticipated survival time more than 12 weeks;
• Male or female aged 30-75 years;
• Those who voluntarily participated in this trial and provided informed consent.

Критерии исключения

Subjects with any of the following exclusion criteria were not eligible for this trial:

• History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
• Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
• Pregnant (or lactating) women;
• Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
• Active infection of hepatitis B virus or hepatitis C virus;
• Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
• Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
• Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;
• Other uncontrolled diseases that were not suitable for this trial;
• Patients with HIV infection;
• Any situations that the investigator believes may increase the risk of patients or interfere with the results of 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

Китай · 1 центр

• The First Affiliated Hospital, Medical College, Zhejiang University — Ханчжоу

Публикации

• Chen R, Jin C, Liu K, Zhao M, Yang T, Zhang M, Xiao P, Feng J, Hong R, Fu S, Cui J, Huang S, Wei G, Huang H, Hu Y. Predictive value of pre-treatment circulating tumor DNA genomic landscape in patients with relapsed/refractory multiple myeloma undergoing anti-BCMA CAR-T therapy: Insights from tumor cells and T cells. Chin Med J (Engl). 2025 Oct 5;138(19):2481-2490. doi: 10.1097/CM9.0000000000003306 PMID 39501801

Идентификаторы

NCT: NCT04670055 · hBCMA-ZhejiangU

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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