Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors

Last updated: March 20, 2026
Sponsor: Immorna Biotherapeutics, Inc.
Overall Status: Completed

Phase

1

Condition

Skin Cancer

Neoplasms

Treatment

JCXH-211 Injection

Clinical Study ID

NCT05727839
JCXH-211-003
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female patients 18-75

  • Patients with malignant solid tumors that have been diagnosed by pathology and/orcytology

  • Patients who have progressed on or who cannot tolerate available therapies or forwhom 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 atleast 10mm and not exceeding 80mm)

  • Patients enrolled in the Skin/subcutaneous lesions and deep (visceral) lesionsstages of Phase Ia must agree to provide pre- and post-treatment tumor biopsytissues

  • Patients must have adequate organ and marrow functions

  • Patients with treated brain metastases are eligible if meeting protocol'srequirement

  • Patients must be ≥ 4 weeks beyond treatment with any chemotherapy (6 weeks fornitrosoureas or mitomycin C), hormonal, biological, targeted agents, otherinvestigational therapy or radiotherapy

Exclusion

Exclusion Criteria:

  • Patients who have received prior IL-12 either alone or as part of a treatmentregimen

  • Patients who have received prior therapy with an immuno-oncology agent and werediscontinued from that treatment due to a Grade 3 or higher immune-related adverseevent (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 recurrenceor active autoimmune disease that requires immunosuppressive medications

  • Patients who had a major surgical procedure within 4 weeks prior to the first doseof study treatment

  • Current or prior use of immunosuppressive medication within 2 weeks prior to thefirst dose of study treatment

  • Patient with history of solid organ or allogenic bone marrow transplantation

Study Design

Total Participants: 19
Treatment Group(s): 1
Primary Treatment: JCXH-211 Injection
Phase: 1
Study Start date:
February 24, 2023
Estimated Completion Date:
September 30, 2024

Study Description

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.

Connect with a study center

  • Sun Yat-sen University Cancer Center

    Guangdong, Guangzhou 510060
    China

    Site Not Available

  • The George Washington Medical Faculty Associates

    Washington D.C., District of Columbia 20037
    United States

    Site Not Available

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