Cutaneous TumorPhase 1NCT05727839
Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors
A Phase 1 study testing JCXH-211 Injection in people with Cutaneous Tumor and Malignant Solid Tumor, run by Immorna Biotherapeutics, Inc. at 2 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cutaneous Tumor, Malignant Solid Tumor
- What is being tested?
- JCXH-211 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 24 Feb 2023to 30 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
The George Washington Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
Official title: A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of JCXH-211 Intratumoral Injection in Patients With 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
Read the detailed 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.
- Conditions
- Cutaneous Tumor, Malignant Solid Tumor
- Being tested
- JCXH-211 Injection
- Keywords
- Tumor, Intratumoral injection
- Medical subject headings
- Skin Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JCXH-211 InjectionDrug
Also called Intratumoral injection
JCXH-211 administered once every 28 days or 14days
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | Dose escalation study of intratumoral injection of JCXH-211 injection into cutaneous/subcutaneous lesions Receives: Drug: JCXH-211 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity
Dose limiting toxicity, evaluated in the Phase Ia, which will be used to determine the MTD and to determine dose escalation.
Measured: Within 28 days or 14days after the first dose
Incidence of adverse events （Safety and Tolerability）
Safety and tolerability as determined by the incidence of adverse events （AEs）, including severe AEs and serious AEs （SAEs）.
Measured: From consent to 28 days after the last dose of study drug
Secondary outcomes (6)
Duration of response （DoR）
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.
Measured: 6 months after the last patient is enrolled.
Disease control rate （DCR）
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.
Measured: 6 months after the last patient is enrolled.
Progression-free survival （PFS）
Progression-free survival is defined as the time from Day 1 to disease progression or death from any cause, whichever occurs earlier.
Measured: 6 months after the last patient is enrolled.
Overall survival （OS）
Overall survival is defined as the time from Day 1 until death due to any cause.
Measured: 6 months after the last patient is enrolled.
Objective response rate （ORR）
Objective response rate is defined as the proportion of patients that achieve a complete response （CR） or partial response （PR） during the study participation.
Measured: 6 months after the last patient is enrolled.
Clinical benefit rate (CBR)
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.
Measured: 6 months after the last patient is enrolled.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start24 Feb 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immorna Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xu ruihua, President, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727839
- Sponsor's protocol ID
- JCXH-211-003
- Status last verified
- Nov 2024
- First submitted
- 1 Feb 2023
- Last updated
- 24 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of JCXH-211 Intratumoral Injection in Patients With Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT05727839
- Acronym / sponsor ID
- JCXH-211-003
- Conditions
- Cutaneous Tumor, Malignant Solid Tumor
- Keywords
- Tumor, Intratumoral injection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Immorna Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
: A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of JCXH-211 Intratumoral Injection in Patients with Malignant Solid Tumors
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Drug: JCXH-211 InjectionDose escalation study of intratumoral injection of JCXH-211 injection into cutaneous/subcutaneous lesions |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JCXH-211 InjectionAlso: Intratumoral injectionJCXH-211 administered once every 28 days or 14days | Drug | Dose escalation |
Primary outcome
Dose limiting toxicity
Time frame: 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.
Incidence of adverse events （Safety and Tolerability）
Time frame: 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）.
6 secondary outcomes
Duration of response （DoR）
Time frame: 6 months after the last patient is enrolled.
Disease control rate （DCR）
Time frame: 6 months after the last patient is enrolled.
Progression-free survival （PFS）
Time frame: 6 months after the last patient is enrolled.
Overall survival （OS）
Time frame: 6 months after the last patient is enrolled.
Objective response rate （ORR）
Time frame: 6 months after the last patient is enrolled.
Clinical benefit rate (CBR)
Time frame: 6 months after the last patient is enrolled.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xu ruihua, President principal investigator
Sun Yat-Sen University Cancer Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JCXH-211 Injection in people with Cutaneous Tumor and Malignant Solid Tumor, run by Immorna Biotherapeutics, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (time frame: Within 28 days or 14days after the first dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.