ASCT in Combination With C-CAR088 for Treating Patients With Ultra High-risk Multiple Myeloma (MM)

Официальное название

The Safety and Efficacy of Autologous Hematopoietic Stem Cell Transplantation (ASCT) in Combination With C-CAR088, an Autologous BCMA CAR-T Cell Product, for Treating Patients With Ultra High-risk Multiple Myeloma

Обзор

This is a phase I/II, single-arm, open-lable study of autologous stem cell transplantation in combination with C-CAR088, an autologous BCMA CAR-T cell product, for patients with ulta high-risk multiple myeloma, defined as failed or unsatisfied responses to front line VRD-based treatment with or without the presence of multiple high-risk cytogenetic features.

Подробное описание

Patients with ultra high-risk multiple myeloma will undergo leukapheresis, stem cell mobilization and collection (could omit if collected before screening), conditioning, ASCT and C-CAR088 infusion. Patients receive a single dose of C-CAR088 three days post-ASCT. Two conditioning protocols and two dose levels of C-CAR088 will be used based on the investigator's discretion. Patients will be evaluated closely for safety of efficacy during the first three months, then less frequently in the following months until 24 months post-ASCT.

Вмешательства

• Процедура Autologous hematopoietic stem cell transplantation
  Patients receive transplantation conditioning followed by autologous hematopoietic stem cell transplantation after successful stem cell mobilization and collection. If previously collected stem cells are available, no stem cell mobilization or collection is required, and patients will receive conditioning directly.
• Биопрепарат C-CAR088
  C-CAR088 is an BCMA targeted Chimeric Antigen Receptor-T cell product. Patients will receive C-CAR088 single dose infusion 3 days after ASCT. The dose level of C-CAR088 will be determined by the investigator.

Первичные конечные точки

• Incidence rate and severity of adverse events (AE) [Срок оценки: 24 months]

Вторичные конечные точки (10)

• Progression free survival (PFS) [Срок оценки: 24 months]
• MRD negativity rate [Срок оценки: 24 months]
• Overall response rate (ORR) [Срок оценки: 24 months]
• Duration of response (DOR) [Срок оценки: 24 months]
• Time to response (TTR) [Срок оценки: 24 months]
• Overall Survival (OS) [Срок оценки: 24 months]
• Cmax (maximal plasma concentration) [Срок оценки: 24 months]
• Tmax (Time to reach the maximal plasma conceration) [Срок оценки: 24 months]
• AUC0-28d (area under the curve from day 0-day 28) [Срок оценки: 28 days post C-CAR088 infusion]
• Tlast (Time of last measurable observed concentration) [Срок оценки: 24 months]

Критерии участия

Критерии включения

• Transplantation eligible patients, male or female, aged 18 to 70 years
• Ultra high risk multiple myeloma, defined as failed or unsatisfied responses to front line VRD-based treatment with or without the presence of multiple high-risk cytogenetic features
• Adequate liver, renal, bone marrow, and heart function
• Eastern Cooperative Oncology Group (ECOG) Performance status 0-1.
• Male and female of reproductive potential must agree to use birth control during the study.

Критерии исключения

• Known allergies to the components or excipients of the C-CAR088 cell product
• Prior allogenic HSCT, or ASCT
• CNS involvement
• Stroke or convulsion history within 6 months prior to signing ICF
• Autoimmune disease, immunodeficiency or disease requiring immunosuppressants treatment
• Uncontrolled active infection; active HBV, HCV infection; HIV or syphilis Infection
• Severe heart, liver, renal or metabolism disease
• Inadequate wash-out time for previous anti-tumor treatments prior to apheresis
• Previous CAR-T cell treatment, genetically modified T-cell therapies or BCMA-directed treatment history
• History or current evidence of any condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's safe participation and compliance in the trial

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

• Institute of Hematology & Blood Diseases Hospital — Тяньцзинь

Идентификаторы

NCT: NCT05632380 · IIT2022012

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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