LCAR-F33S in Treatment of Relapsed/Refractory Multiple Myeloma

Официальное название

A Clinical Study to Evaluate the Safety, Tolerance and Efficacy of LCAR- F33S Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma.

Обзор

A prospective, single-arm, open-label dose-exploration and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-F33S in patients with relapsed/refractory multiple myeloma(Investigator-initiated Study).

Подробное описание

This study is a prospective, single-arm, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-F33S in patients with relapsed/refractory multiple myeloma. All subjects who meet the eligibility criteria will receive intravenous injection of LCAR-F33S cell injection. The study will include the following sequential phases: screening, apheresis, pre-treatment (lymphodepleting chemotherapy), treatment, and follow-up.

Вмешательства

• Биопрепарат LCAR- F33S cells intravenous infusion
  Prior to infusion of the LCAR- F33S cell, Subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.

Первичные конечные точки

• Dose-limiting toxicity (DLT) rate. [Срок оценки: From LCAR-F33S cell infusion (Day 1) until the 30th day of follow-up period, assessed up to 30 days]
• Incidence, severity, and type of treatment-emergent adverse events (TEAEs) [Срок оценки: From the date of signing ICF to the date 2 years after LCAR-F33S cell infusion]
• To determine the recommended dose for phase II clinical trials (RP2D) [Срок оценки: through the last subject of DLT exploration completion, about 2years.]
• Maximum concentration (Cmax) [Срок оценки: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion, assessed about 2 years]
• Time to Cmax [Срок оценки: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion, assessed about 2 years]
• Time to the last observed concentration [Срок оценки: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years]
• Area Under the Curve (AUC) of the concentration [Срок оценки: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion, assessed about 2 years.]

Вторичные конечные точки (10)

• Objective Response Rate (ORR) [Срок оценки: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion, assessed about 2 years]
• Very Good Partial Response Rate（VGPR） [Срок оценки: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years]
• Complete response(CR) [Срок оценки: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years]
• Stringent complete response(sCR) [Срок оценки: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years]
• Minimal residual disease (MRD) negative rate [Срок оценки: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression, assessed about 2 years]
• Time-to-response(TTR) [Срок оценки: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion, assessed about 2 years]
• Duration of response(DOR) [Срок оценки: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years.]
• Progression-free survival(PFS) [Срок оценки: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion, assessed about 2 years.]
• Overall survival(OS) [Срок оценки: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion, assessed about 2 years.]
• Occurrence rate of antidrug antibody [Срок оценки: From LCAR-F33S cells infusion until the date of first documented progression or study completion, assessed about 2 years.]

Критерии участия

Критерии включения

• Subjects voluntarily participate in clinical research.
• Age ≥18 years old.
• Eastern Cooperative Oncology Group (ECOG) score 0-2.
• Examination evidence of initial diagnosis of MM according to IMWG diagnostic criteria.
• Measurable lesions were present.
• Subjects have received treatment with one PI, one IMiD and a CD38 monoclonal antibody.
• Subjects have received at least three previous lines of multiple myeloma therapy, each with at least one complete therapy cycle, unless the best response to the therapeutic regimen was documented as disease progression (PD confirmed according to IMWG criteria).
• Expected survival ≥3 months.
• Clinical laboratory values in the screening period meet criteria.

Критерии исключения

• Received previous therapy targeting FcRH5 targets.
• Prior antineoplastic therapy and meet exclusion criteria (before apheresis);
• Subjects had Plasma cell leukemia, Waldenstrom macroglobulinemia, POEMS syndrome, or primary AL amyloidosis at the time of screening.
• Subjects who were positive for any of HBsAg, HBV DNA, HCV-Ab, HCV RNA, and HIV-Ab;
• Life-threatening allergic reactions, hypersensitivity reactions, or intolerance to CAR-T cell formulations or their excipients, including DMSO, are known.
• Serious underlying diseases were present.
• Female subjects who were pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving study treatment.
• Also enrolled in other clinical studies.

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 · 4 центра

• Beijing Boren Hospital — Пекин
• Institute of Hematology & Blood Diseases Hospital — Тяньцзинь
• Institute of Hematology & Blood Diseases Hospital — Тяньцзинь
• Wuhan Union Hospital — Ухань

Идентификаторы

NCT: NCT07100067 · LB2502-0001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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