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

10 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

80

Phase

  • Phase 2
  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

  • Nom: Novartis Pharmaceuticals
  • Numéro de téléphone: +41613241111

Lieux d'étude

  • Australie
    • Victoria
      • Clayton, Victoria, Australie, 3168
        • Recrutement
        • Novartis Investigative Site
  • Corée du Sud
      • Seoul, Corée du Sud, 05505
        • Recrutement
        • Novartis Investigative Site
  • Singapour
      • Singapore, Singapour, 168583
        • Recrutement
        • Novartis Investigative Site
  • États-Unis
    • Kentucky
      • Lexington, Kentucky, États-Unis, 40536
        • Recrutement
        • University of Kentucky
        • Chercheur principal:
          • Zhonglin Hao
        • Contact:
    • Texas
      • Houston, Texas, États-Unis, 77030
        • Recrutement
        • MD Anderson Cancer Center
        • Contact:
        • Chercheur principal:
          • Bingnan Zhang
    • Washington
      • Seattle, Washington, États-Unis, 98109
        • Recrutement
        • Fred Hutchinson Cancer Center
        • Chercheur principal:
          • Diane Tseng
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Phase I
Dose escalation with DJI136
Médicament: DJI136
DLL3 targeted CAR-T therapy administered by intravenous (i.v.) infusion.
Expérimental: Phase II
Treatment at the recommended dose(s) of DJI136 as identified in Phase I.
Médicament: DJI136
DLL3 targeted CAR-T therapy administered by intravenous (i.v.) infusion.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
All study parts: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Délai: 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)
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Phase I Part A and Phase II exploratory group: Overall response rate (ORR) as per RECIST v1.1
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Novartis Pharmaceuticals

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

16 juin 2026

Achèvement primaire (Estimé)

3 mars 2031

Achèvement de l'étude (Estimé)

3 mars 2031

Dates d'inscription aux études

Première soumission

27 avril 2026

Première soumission répondant aux critères de contrôle qualité

27 avril 2026

Première publication (Réel)

4 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CDJI136A12101
  • 2025 (Subvention/contrat des NIH des États-Unis: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-523276-23 (Autre identifiant: EU CTIS)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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/.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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