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Undersøgelse for at evaluere JCXH-211 som monoterapi hos patienter med ondartede solide tumorer

4. november 2026 opdateret af: Immorna Biotherapeutics, Inc.

Et fase 1 åbent studie for at evaluere sikkerheden, tolerabiliteten og effektiviteten af ​​JCXH-211 intratumoral injektion hos patienter med ondartede solide tumorer

: A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of JCXH-211 Intratumoral Injection in Patients with Malignant Solid Tumors

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The main purpose of this study is to find out how safe and tolerable the study drug, JCXH-211, is and also how well it works in people with malignant solid tumors. The study drug JCXH-211, is an immunotherapy drug. This means that it aims to work by boosting immune system's response to tumors, to help fight against the growth of the cancer cells. The study has 2 main phases: Phase

1a and Phase 1b. Phase 1a has 2 stages, skin/subcutaneous lesions stage, deep (visceral) lesions stage. Phase 1b will not start until all the data collected in Phase 1a has been completed and reviewed to check that it is safe and well tolerated.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

19

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • District of Columbia
      • Washington D.C., District of Columbia, Forenede Stater, 20037
        • The George Washington Medical Faculty Associates
  • Kina
    • Guangzhou
      • Guangdong, Guangzhou, Kina, 510060
        • Sun Yat-sen University Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Male or female patients 18-75
  • Patients with malignant solid tumors that have been diagnosed by pathology and/or cytology
  • Patients who have progressed on or who cannot tolerate available therapies or for whom curative therapy does not exist
  • Patients with at least one non-injected measurable tumor lesion per RECIST v1.1
  • Patients with lesions suitable for intratumoral injection (the lesion length is at least 10mm and not exceeding 80mm)
  • Patients enrolled in the Skin/subcutaneous lesions and deep （visceral） lesions stages of Phase Ia must agree to provide pre- and post-treatment tumor biopsy tissues
  • Patients must have adequate organ and marrow functions
  • Patients with treated brain metastases are eligible if meeting protocol's requirement
  • Patients must be ≥ 4 weeks beyond treatment with any chemotherapy (6 weeks for nitrosoureas or mitomycin C), hormonal, biological, targeted agents, other investigational therapy or radiotherapy

Exclusion Criteria:

  • Patients who have received prior IL-12 either alone or as part of a treatment regimen
  • Patients who have received prior therapy with an immuno-oncology agent and were discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE)
  • Patients requiring therapeutic doses of anticoagulation
  • Patients with tumors that impinge on major airways, blood vessels, or nerve bundles
  • Patients with a history of autoimmune disease that has the possibility of recurrence or active autoimmune disease that requires immunosuppressive medications
  • Patients who had a major surgical procedure within 4 weeks prior to the first dose of study treatment
  • Current or prior use of immunosuppressive medication within 2 weeks prior to the first dose of study treatment
  • Patient with history of solid organ or allogenic bone marrow transplantation

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Dose escalation

Dose escalation study of intratumoral injection of JCXH-211 injection into cutaneous/subcutaneous lesions
Medicin: JCXH-211 Injection

JCXH-211 administered once every 28 days or 14days

Andre navne:
  • Intratumoral injektion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dose limiting toxicity
Tidsramme: Within 28 days or 14days after the first dose

Dose limiting toxicity, evaluated in the Phase Ia, which will be used to determine the MTD and to determine dose escalation.
Within 28 days or 14days after the first dose
Incidence of adverse events （Safety and Tolerability）
Tidsramme: From consent to 28 days after the last dose of study drug

Safety and tolerability as determined by the incidence of adverse events （AEs）, including severe AEs and serious AEs （SAEs）.
From consent to 28 days after the last dose of study drug

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Duration of response （DoR）
Tidsramme: 6 months after the last patient is enrolled.

Duration of response is defined as the time from the first assessment of tumor as CR or PR to the first assessment as progressive disease or death from any cause.
6 months after the last patient is enrolled.
Disease control rate （DCR）
Tidsramme: 6 months after the last patient is enrolled.

Disease control rate is defined as the proportion of patients with CR or PR or stable disease （SD） with the DoR ≥ 12weeks observed from Day 1 to disease progression.
6 months after the last patient is enrolled.
Progression-free survival （PFS）
Tidsramme: 6 months after the last patient is enrolled.

Progression-free survival is defined as the time from Day 1 to disease progression or death from any cause, whichever occurs earlier.
6 months after the last patient is enrolled.
Overall survival （OS）
Tidsramme: 6 months after the last patient is enrolled.

Overall survival is defined as the time from Day 1 until death due to any cause.
6 months after the last patient is enrolled.
Objective response rate （ORR）
Tidsramme: 6 months after the last patient is enrolled.

Objective response rate is defined as the proportion of patients that achieve a complete response （CR） or partial response （PR） during the study participation.
6 months after the last patient is enrolled.
Clinical benefit rate (CBR)
Tidsramme: 6 months after the last patient is enrolled.

Clinical benefit rate is defined as the proportion of patients with the best response of CR, PR, or SD (duration ≥ 24 weeks) throughout the study from Day 1 of treatment with the study drug to disease progression.
6 months after the last patient is enrolled.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Immorna Biotherapeutics, Inc.

Efterforskere

  • Ledende efterforsker: Xu ruihua, President, Sun Yat-Sen University Cancer Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

24. februar 2023

Primær færdiggørelse (Faktiske)

30. september 2024

Studieafslutning (Faktiske)

30. september 2024

Datoer for studieregistrering

Først indsendt

1. februar 2023

Først indsendt, der opfyldte QC-kriterier

6. februar 2023

Først opslået (Faktiske)

14. februar 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2026

Sidst verificeret

1. november 2024

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • JCXH-211-003

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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