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A Study to Evaluate DJI136, a DLL3-targeted CAR-T Therapy

2026年9月10日 更新者：Novartis Pharmaceuticals

A Phase I/II Open-label Study of DJI136, a DLL3-targeted CAR-T Therapy, in Adult Patients With ES-SCLC

This is a Phase I/II, open-label, non-randomized, multi-center study in patients with extensive-stage small cell lung cancer (ES-SCLC) to determine the recommended dose(s) (RD) and to evaluate the safety, tolerability and preliminary efficacy of DJI136.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

This is a first in human (FIH) Phase I/II, multicenter, open-label study of DJI136 (a CAR-T therapy). The study will start with a Phase I dose escalation with two parts: Part A where patients with ES-SCLC that experience disease progression after one or more chemotherapy regimens according to the standard of care (SOC) will be treated with DJI136. The second part is an optional exploratory component.

The Phase II may follow with two groups. In Group A, ES-SCLC patients who have disease progression after one standard chemotherapy regimen according to the SOC may receive the dose of DJI136 identified in Phase I to assess the preliminary anti-tumor activity of DJI136. The second group is an optional exploratory component.

研究の種類

介入

入学 (推定)

80

段階

  • フェーズ2
  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

  • 名前：Novartis Pharmaceuticals
  • 電話番号：+41613241111

研究場所

  • アメリカ
    • Kentucky
      • Lexington、Kentucky、アメリカ、40536
        • 募集
        • University of Kentucky
        • 主任研究者：
          • Zhonglin Hao
        • コンタクト：
    • Texas
      • Houston、Texas、アメリカ、77030
        • 募集
        • MD Anderson Cancer Center
        • コンタクト：
        • 主任研究者：
          • Bingnan Zhang
    • Washington
      • Seattle、Washington、アメリカ、98109
        • 募集
        • Fred Hutchinson Cancer Center
        • 主任研究者：
          • Diane Tseng
        • コンタクト：
  • オーストラリア
    • Victoria
      • Clayton、Victoria、オーストラリア、3168
        • 募集
        • Novartis Investigative Site
  • シンガポール
      • Singapore、シンガポール、168583
        • 募集
        • Novartis Investigative Site
  • 韓国
      • Seoul、韓国、05505
        • 募集
        • Novartis Investigative Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

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

いいえ

説明

Inclusion Criteria:

  • Phase I: Patients with ES-SCLC and disease progression after one or more chemotherapy regimens (that included a platinum-based doublet chemotherapy in combination with a PD-L1 inhibitor) according to the local SOC (2L+), unless the patient was ineligible to receive such therapies or was not a candidate for any available standard therapy, according to the investigator's judgement. Prior DLL3 (Delta-like ligand 3) targeted therapy is allowed.
  • Phase II: Patients with ES-SCLC who have received a platinum-based doublet chemotherapy in combination with a PD-L1 inhibitor according to local standard of care, unless the patient was ineligible to receive such therapies or was not a candidate for any available standard therapy, as determined by the investigator's judgment. Prior DLL-3 targeted therapy is not allowed.
  • Male or female patients must be ≥ 18 years of age.
  • Histologically or cytologically confirmed small cell lung cancer (SCLC).
  • At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Patients must have an archival tumor tissue available, collected within 6 months prior to screening. If an archival tumor sample, collected within 6 months prior to screening, is not available, patients must be willing to undergo a new tumor biopsy at screening; , however this specimen need not be collected prior to scheduling leukapheresis. If a new biopsy is not medically feasible, exceptions may be considered after documented discussion with the Novartis medical monitor.
  • Patient must be deemed suitable by the investigator to undergo the lymphodepletion (LD) regimen.
  • Patient must have an apheresis product of non-mobilized cells accepted for manufacturing.

Exclusion Criteria:

  • Prior administration of a genetically modified cellular product, including prior DLL3-targeted CAR-T cell therapy.
  • Unstable or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis. Stable brain metastases may participate provided they meet the specific criteria.
  • Uncontrolled seizure disorder.
  • Clinically significant active infections, including Hepatitis B/C and Human Immunodeficiency Virus (HIV).
  • Has a known additional malignancy that is progressing or requires active treatment, with specific exceptions as defined in the study protocol.
  • History of prior solid organ transplant or allogenic hematopoietic cell transplant
  • Other significant pulmonary, cardiac, hepatic, renal or neurologic disease, parameters for which are defined in the study protocol.
  • Pregnant or nursing women.

Other protocol-defined inclusion/exclusion criteria may apply.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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：非ランダム化
  • 介入モデル：順次割り当て
  • 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：Phase I
Dose escalation with DJI136
薬：DJI136
DLL3 targeted CAR-T therapy administered by intravenous (i.v.) infusion.
実験的：Phase II
Treatment at the recommended dose(s) of DJI136 as identified in Phase I.
薬：DJI136
DLL3 targeted CAR-T therapy administered by intravenous (i.v.) infusion.

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
All study parts: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
時間枠：Up to approximately 2 years
Number of participants with AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
Up to approximately 2 years
All study parts: Incidence and severity of dose-limiting toxicities (DLTs)
時間枠：28 days
Number of participants with DLTs. A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first 28 days after DJI136 infusion and meets the criteria defined in the protocol. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
28 days
Phase II Group A: Overall response rate (ORR) as per RECIST v1.1
時間枠：Up to approximately 2 years

Tumor response assessed by the investigator based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

ORR per RECIST v1.1 is defined as the proportion of patients with a confirmed best overall response of Complete response (CR) or Partial response (PR).
Up to approximately 2 years

二次結果の測定

結果測定
メジャーの説明
時間枠
Phase I Part A and Phase II exploratory group: Overall response rate (ORR) as per RECIST v1.1
時間枠：Up to approximately 2 years

Tumor response assessed by the investigator based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

ORR per RECIST v1.1 is defined as the proportion of patients with a confirmed best overall response of Complete response (CR) or Partial response (PR).
Up to approximately 2 years
Phase I Part A and Phase II: Disease control rate (DCR) as per RECIST v1.1
時間枠：Up to approximately 2 years

Tumor response assessed by the investigator based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

DCR per RECIST v1.1 is defined as the proportion of patients with a confirmed best overall response of CR, PR, or Stable disease (SD).
Up to approximately 2 years
Phase I Part A and Phase II: Duration of response (DOR) as per RECIST v1.1
時間枠：Up to approximately 2 years

Tumor response assessed by the investigator based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

DOR is defined as the time from the date of the first documented response (CR or PR) to the date of the first documented progression according to RECIST v1.1 or death due to underlying cancer.
Up to approximately 2 years
Phase I Part A and Phase II: Progression free survival (PFS) as per RECIST v1.1
時間枠：Up to approximately 2 years

Tumor response assessed by the investigator based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

PFS is defined as the time from the date of DJI136 infusion to the date of the first documented progression according to RECIST v1.1, or death due to any cause.
Up to approximately 2 years
Phase I Part A and Phase II: Maximum observed concentration (Cmax) in peripheral blood
時間枠：From pre-dose up to Day 720 (Month 24)
Cellular kinetics parameters will be determined by non-compartmental method(s) based on DJI136 chimeric antigen receptor (CAR) transgene concentrations in peripheral blood.
From pre-dose up to Day 720 (Month 24)
Phase I Part A and Phase II: Time to reach maximum observed concentration (Tmax) in peripheral blood
時間枠：From pre-dose up to Day 720 (Month 24)
Cellular kinetics parameters will be determined by non-compartmental method(s) based on DJI136 CAR transgene concentrations in peripheral blood.
From pre-dose up to Day 720 (Month 24)
Phase I Part A and Phase II: Area under the peripheral blood concentration-time curve (AUC)
時間枠：From pre-dose up to Day 720 (Month 24)
Cellular kinetics parameters will be determined by non-compartmental method(s) based on DJI136 CAR transgene concentrations in peripheral blood.
From pre-dose up to Day 720 (Month 24)
Phase I Part A and Phase II: Last observed quantifiable concentration (Clast) in peripheral blood
時間枠：From pre-dose up to Day 720 (Month 24)
Cellular kinetics parameters will be determined by non-compartmental method(s) based on DJI136 CAR transgene concentrations in peripheral blood.
From pre-dose up to Day 720 (Month 24)
Phase I Part A and Phase II: Time of last observed quantifiable concentration (Tlast) in peripheral blood
時間枠：From pre-dose up to Day 720 (Month 24)
Cellular kinetics parameters will be determined by non-compartmental method(s) based on DJI136 CAR transgene concentrations in peripheral blood.
From pre-dose up to Day 720 (Month 24)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Novartis Pharmaceuticals

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年6月16日

一次修了 (推定)

2031年3月3日

研究の完了 (推定)

2031年3月3日

試験登録日

最初に提出

2026年4月27日

QC基準を満たした最初の提出物

2026年4月27日

最初の投稿 (実際)

2026年5月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月11日

QC基準を満たした最後の更新が送信されました

2026年9月10日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • CDJI136A12101
  • 2025 (米国 NIH グラント/契約：Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-523276-23 (その他の識別子：EU CTIS)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.

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

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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