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

10. september 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

80

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

  • Navn: Novartis Pharmaceuticals
  • Telefonnummer: +41613241111

Studiesteder

  • Australia
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Rekruttering
        • Novartis Investigative Site
  • Forente stater
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40536
        • Rekruttering
        • University of Kentucky
        • Hovedetterforsker:
          • Zhonglin Hao
        • Ta kontakt med:
    • Texas
      • Houston, Texas, Forente stater, 77030
        • Rekruttering
        • MD Anderson Cancer Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bingnan Zhang
    • Washington
      • Seattle, Washington, Forente stater, 98109
        • Rekruttering
        • Fred Hutchinson Cancer Center
        • Hovedetterforsker:
          • Diane Tseng
        • Ta kontakt med:
  • Singapore
      • Singapore, Singapore, 168583
        • Rekruttering
        • Novartis Investigative Site
  • Sør -Korea
      • Seoul, Sør -Korea, 05505
        • Rekruttering
        • Novartis Investigative Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Phase I
Dose escalation with DJI136
Legemiddel: DJI136
DLL3 targeted CAR-T therapy administered by intravenous (i.v.) infusion.
Eksperimentell: Phase II
Treatment at the recommended dose(s) of DJI136 as identified in Phase I.
Legemiddel: DJI136
DLL3 targeted CAR-T therapy administered by intravenous (i.v.) infusion.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
All study parts: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Phase I Part A and Phase II exploratory group: Overall response rate (ORR) as per RECIST v1.1
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Novartis Pharmaceuticals

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

16. juni 2026

Primær fullføring (Antatt)

3. mars 2031

Studiet fullført (Antatt)

3. mars 2031

Datoer for studieregistrering

Først innsendt

27. april 2026

Først innsendt som oppfylte QC-kriteriene

27. april 2026

Først lagt ut (Faktiske)

4. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CDJI136A12101
  • 2025 (U.S. NIH-stipend/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-523276-23 (Annen identifikator: EU CTIS)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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/.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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