Cutaneous TumorPhase 1NCT05539157
Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors
A Phase 1 study testing JCXH-211 in people with Cutaneous Tumor and Malignant Solid Tumor, run by Immorna Biotherapeutics, Inc. at 1 site in United States.
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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2022to 17 Apr 2023
- 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
- All of the following conditions should be met at screening:
- 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 10 mm and not exceeding 80 mm)
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- Patients enrolled in the single and multiple administration stages of Phase 1a 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
Who cannot join
- Patients who meet any of the following criteria will be excluded from study entry:
- 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
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- 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
1 site in 1 country.
United States1 site
University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77230-1407
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 3 stages, Single administration stage, Multiple administration stage and Visceral 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
- 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-211Drug
JCXH-211 administered once every 28 days
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a:Dose escalation | Experimental | JCXH-211 will be delivered by intratumoral injection in 3 stages:
Single administration stage A single administration of JCXH-211 administered to cutaneous or subcutaneous lesions in escalating doses.
Multiple administration stage Up to 3 doses of JCXH-211 administered to a cutaneous or subcutaneous lesion in escalating doses. Assigned dose to be determined on the data from the single administration arm.
Visceral administration stage JCXH-211 administered to a visceral lesion in escalating doses. Assigned dose to be determined on the data from the single and multiple administration arms. Receives: Drug: JCXH-211 |
| Phase 1b:Dose expansion | Experimental | JCXH-211 will be delivered by intratumoral injection. The dose to be used will be determined after review of the data from Phase 1a. Receives: Drug: JCXH-211 |
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 single administration stage of Phase 1a, which will be used to determine the MTD and to determine dose escalation
Measured: Day 1 to Day 29
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 30 days after the last dose of study drug
Secondary outcomes (6)
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: Up to 12 months
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: Up to 12 months following first reported response
Time to response (TTR)
Time to response is defined as the time from Day 1 until the first documentation of objective response (CR or PR).
Measured: Up to 12 months from the start of study therapy
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 ≥ 12 weeks observed from Day 1 to disease progression.
Measured: Up to 12 months
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: Up to 12 months
Overall survival (OS)
Overall survival is defined as the time from Day 1 until death due to any cause.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start19 Oct 2022
- Primary completion17 Apr 2023
- Study completion17 Apr 2023
Why it stopped: Due to extremely low accrual rate
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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immorna Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539157
- Sponsor's protocol ID
- 2021-JCXH-211-001
- Status last verified
- Nov 2026
- First submitted
- 30 Aug 2022
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 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
- NCT05539157
- Acronym / sponsor ID
- 2021-JCXH-211-001
- Conditions
- Cutaneous Tumor, Malignant Solid Tumor
- Keywords
- Tumor, Intratumoral injection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to extremely low accrual rate
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Immorna Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 17 Apr 2023 (actual)
- Study completion
- 17 Apr 2023 (actual)
- First posted
- 14 Sep 2022 (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 3 stages, Single administration stage, Multiple administration stage and Visceral 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1a:Dose escalation | Experimental | Drug: JCXH-211JCXH-211 will be delivered by intratumoral injection in 3 stages: Single administration stage A single administration of JCXH-211 administered to cutaneous or subcutaneous lesions in escalating doses. Multiple administration stage Up to 3 doses of JCXH-211 administered to a cutaneous or subcutaneous lesion in escalating doses. Assigned dose to be determined on the data from the single administration arm. Visceral administration stage JCXH-211 administered to a visceral lesion in escalating doses. Assigned dose to be determined on the data from the single and multiple administration arms. |
| Phase 1b:Dose expansion | Experimental | Drug: JCXH-211JCXH-211 will be delivered by intratumoral injection. The dose to be used will be determined after review of the data from Phase 1a. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 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 10 mm and not exceeding 80 mm)
Key exclusion criteria (9 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-211JCXH-211 administered once every 28 days | Drug | Phase 1a:Dose escalation, Phase 1b:Dose expansion |
Primary outcome
Dose limiting toxicity
Time frame: Day 1 to Day 29
Dose limiting toxicity, evaluated in the single administration stage of Phase 1a, 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 30 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
Objective response rate (ORR)
Time frame: Up to 12 months
Duration of response (DOR)
Time frame: Up to 12 months following first reported response
Time to response (TTR)
Time frame: Up to 12 months from the start of study therapy
Disease control rate (DCR)
Time frame: Up to 12 months
Progression-free survival (PFS)
Time frame: Up to 12 months
Overall survival (OS)
Time frame: Up to 24 months
Results and safety
The study was stopped early (reason given: Due to extremely low accrual rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JCXH-211 in people with Cutaneous Tumor and Malignant Solid Tumor, run by Immorna Biotherapeutics, Inc. at 1 site in United States.
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 10 inclusion and 9 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: stopped early, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was stopped early (reason given: Due to extremely low accrual rate). Results are not available in the source record.
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: Day 1 to Day 29). 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 5 Nov 2026.