Inhaled mRNA Immunotherapy for Patients With Advanced Lung Cancer or Pulmonary Metastatic Solid Tumors (BMD-PLAT)
A Platform Study of In Vivo Inhaled mRNA Technology for Multi-Target Immunotherapy Against Solid Tumors
調査の概要
詳細な説明
This is an open-label, single-arm, phase I master platform clinical trial designed to assess the safety, tolerability, pharmacokinetic profiles and preliminary anti-tumor activity of multiple investigational inhaled in-vivo mRNA multi-target immunotherapy candidates in adult subjects diagnosed with unresectable locally advanced or metastatic solid tumors.
The study adopts the standard 3+3 dose-escalation design for each individual mRNA product. Eligible participants will receive study drug via pulmonary inhalation on predefined treatment cycles with gradual dose increment across sequential cohorts to identify the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). After completion of dose escalation, an optional expansion cohort at RP2D will be enrolled to further characterize safety and preliminary anti-tumor efficacy.
All enrolled patients will undergo regular safety monitoring including adverse event recording, laboratory examinations, pulmonary function test and radiological tumor assessment per protocol schedule. The primary study endpoints focus on treatment-related adverse events and MTD determination; secondary endpoints include objective response rate, disease control rate, duration of response as well as pharmacokinetic parameters of inhaled mRNA agents. Subjects will continue assigned study treatment until confirmed disease progression, unacceptable toxicity, withdrawal of consent or study closure.
研究の種類
入学 (推定)
段階
- 初期フェーズ 1
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Male or female patients aged ≥ 18 years.
- Confirmed diagnosis of advanced lung cancer (driver gene negative or targeted therapy failed) or pulmonary metastatic solid tumors, with no standard treatment options available or who have failed prior standard therapies.
- Presence of at least one measurable lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function, including hematologic, hepatic, and renal function.
- Ability to understand and sign the informed consent form.
- Expected survival of at least 12 weeks.
Exclusion Criteria:
- History of severe hypersensitivity to mRNA-based therapies or components of the study drug.
- Uncontrolled active infection or severe underlying respiratory disease (e.g., severe COPD, asthma requiring high-dose steroids).
- Prior allogeneic stem cell or solid organ transplantation.
- Current use of other investigational agents within 4 weeks before the first dose of study treatment.
- Active autoimmune disease requiring systemic immunosuppressive therapy.
- Pregnant or breastfeeding women.
- Any condition that, in the investigator's opinion, would interfere with study compliance or safety.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Inhaled mRNA Immunotherapy
All enrolled subjects will receive inhaled mRNA immunotherapy via Breezhaler dry powder inhaler.
Dose escalation will follow a standard 3+3 design. Treatment duration will not exceed 52 weeks. |
Inhaled mRNA dry powder formulation, administered via a low-resistance dry powder inhaler.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Safety and Tolerability
時間枠：From the first dose of study treatment up to 30 days after the last dose.
|
The primary endpoint is to assess the safety and tolerability of inhaled mRNA immunotherapy, including the incidence and severity of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs).
|
From the first dose of study treatment up to 30 days after the last dose.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Maximum Tolerated Dose (MTD) / Recommended Phase 2 Dose (RP2D)
時間枠：Up to 28 days after the last dose in each dose cohort.
|
To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of inhaled mRNA immunotherapy using a standard 3+3 dose-escalation design.
|
Up to 28 days after the last dose in each dose cohort.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- NCC6293 (その他の識別子：National Cancer Center/Cancer Hospital, CAMS)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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