Evaluating JCXH-211 for treating malignant solid tumors
A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of JCXH-211 Intratumoral Injection in Patients With Malignant Solid Tumors
This study is testing a new immunotherapy drug called JCXH-211 to see if it can safely help people with malignant solid tumors by boosting their immune response against cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Immorna Biotherapeutics, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Guangdong, Guangzhou) |
| Trial ID | NCT05727839 on ClinicalTrials.gov |
What this trial studies
This Phase 1 open-label study aims to assess the safety, tolerability, and efficacy of the immunotherapy drug JCXH-211 administered via intratumoral injection in patients with malignant solid tumors. The study consists of two main phases: Phase 1a, which includes two stages focusing on skin/subcutaneous lesions and deep visceral lesions, and Phase 1b, which will commence after reviewing data from Phase 1a to ensure safety and tolerability. The goal is to enhance the immune system's response to combat cancer cell growth.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-75 with malignant solid tumors that have progressed on or are intolerant to existing therapies.
Not a fit: Patients with tumors that are not suitable for intratumoral injection or those who have not progressed on available therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new immunotherapy option for patients with malignant solid tumors who have limited treatment alternatives.
How similar studies have performed: While this approach is novel, similar immunotherapy strategies have shown promise in treating various cancers, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Guangdong, Guangzhou
- Sun Yat-sen University Cancer Center — Guangdong, Guangzhou, China (Recruiting)
Study contacts
- Principal investigator: Xu ruihua, President — Sun Yat-sen University
- Study coordinator: Qi Wang
- Email: qi.wang@immorna.com
- Phone: +8613381113913
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.