Malignant Solid TumorsPhase 1/2NCT06781125
One Trial of JCXH-211 Intratumoral Injection Combined With Anti-PD-1 Antibody in Patients With Malignant Solid Tumors
A Phase 1/2 study testing JCXH-211 Intratumoral Injection Combined with Anti-PD-1 Antibody IV infusion in people with Malignant Solid Tumors, run by Immorna Biotherapeutics, Inc. at 1 site in China.
Trial summary
This is an open-label, dose-escalation and dose-expansion Phase I /II clinical study divided into Phase I and Phase II to evaluate the safety and tolerability of JCXH-211 combined with anti-PD-1 antibody 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
- Malignant Solid Tumors
- What is being tested?
- JCXH-211 Intratumoral Injection Combined with Anti-PD-1 Antibody IV infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2025to 30 Jun 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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, aged 18 to 75 years;
- patients with malignant solid tumors confirmed by pathology and/or cytology who have progressed or are intolerant to standard treatment (except best supportive care); Including patients who have received prior anti-PD-1 antibody therapy; patients who have been approved as eligible for Toripalimab:
- General condition score ECOG 0 ~ 1;
- Expected survival of more than 3 months;
Who cannot join
- Known or suspected allergy to the ingredients of the study drug or its analogues; allergic history to another monoclonal antibody;
- patients who have previously received IL-12 therapy (alone or as part of a treatment regimen), except those who have participated in tolerance to a single intratumoral injection;
- patients who have previously received treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or have received treatment directed at another stimulatory or coinhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137), and discontinued treatment due to Grade 3 or higher immune-related adverse events (irAEs);
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Principal Investigator, 86-20-87343468, xurh@sysucc.org.cn
About this study
Official title: A Phase I/II Clinical Trial to Evaluate the Safety and Tolerability of JCXH-211 Intratumoral Injection Combined With Anti-PD-1 Antibody IV Infusion in Patients With Malignant Solid Tumors
This is an open-label, dose-escalation and dose-expansion Phase I /II clinical study divided into Phase I and Phase II to evaluate the safety and tolerability of JCXH-211 combined with anti-PD-1 antibody in patients with malignant solid tumors.
Read the detailed description
Phase I: Dose escalation study of intratumoral injection of JCXH-211 combined with anti-PD-1 antibody IV infusion A dose escalation study of intratumoral injection of JCXH-211 combined with anti-PD-1 antibody IV infusion will be planned in 2 dose groups . Three to six patients will be enrolled in each dose group.
Phase II:Dose Expansion Study of JCXH-211 Combined with Anti-PD-1 Antibody In this part of the study, the sponsor and investigator select the optimal dose based on the safety, PK, PD and preliminary efficacy results of the dose escalation phase, and select 1 to 2 of the tumors for JCXH-211 combined with anti-PD-1 antibody dose expansion study with reference to the approved indications of anti-PD-1 antibody (Toripalimab ) in China, and planned to enroll 15 to 30 patients in each cohort of combination therapy.
Tumor response assessments will be performed using RECIST1.1 and iRECIST at the end of study treatment/early withdrawal visit and every 6 weeks during treatment.
All patients will be followed for safety and survival. The data cut-off date for study is defined as 6 months after the last patient is enrolled.
- Conditions
- Malignant Solid Tumors
- Being tested
- JCXH-211 Intratumoral Injection Combined with Anti-PD-1 Antibody IV infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JCXH-211 Intratumoral Injection Combined with Anti-PD-1 Antibody IV infusionDrug
JCXH-211:Tumor lesions are selected for intratumoral injection, and target or non-target lesions can be selected. The number of lesions selected for injection will be at the investigator 's discretion based on the patient' s general condition and tolerability .
Anti-PD-1 antibody:Dosage and administration according to the instructions.
| Study group | Role | What they receive |
|---|---|---|
| Phase Ia will be planned in 2 dose groups, Phase Ib will select the optimal dose based Phase Ia | Experimental | Not described Receives: Drug: JCXH-211 Intratumoral Injection Combined with Anti-PD-1 Antibody IV infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Measured: The DLT observation period is 28 days after first dose of JCXH-211 combined with anti-PD-1 antibody
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start23 May 2025
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid TumorsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immorna Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- RuiHua Xu, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781125
- Sponsor's protocol ID
- JCXH-211-006
- Status last verified
- Nov 2026
- First submitted
- 12 Nov 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- 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 I/II Clinical Trial to Evaluate the Safety and Tolerability of JCXH-211 Intratumoral Injection Combined With Anti-PD-1 Antibody IV Infusion in Patients With Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT06781125
- Acronym / sponsor ID
- JCXH-211-006
- Conditions
- Malignant Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Immorna Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 May 2025 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 17 Jan 2025 (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.
This is an open-label, dose-escalation and dose-expansion Phase I /II clinical study divided into Phase I and Phase II to evaluate the safety and tolerability of JCXH-211 combined with anti-PD-1 antibody in patients with malignant solid tumors.
Detailed description
Phase I: Dose escalation study of intratumoral injection of JCXH-211 combined with anti-PD-1 antibody IV infusion A dose escalation study of intratumoral injection of JCXH-211 combined with anti-PD-1 antibody IV infusion will be planned in 2 dose groups . Three to six patients will be enrolled in each dose group.
Phase II:Dose Expansion Study of JCXH-211 Combined with Anti-PD-1 Antibody In this part of the study, the sponsor and investigator select the optimal dose based on the safety, PK, PD and preliminary efficacy results of the dose escalation phase, and select 1 to 2 of the tumors for JCXH-211 combined with anti-PD-1 antibody dose expansion study with reference to the approved indications of anti-PD-1 antibody (Toripalimab ) in China, and planned to enroll 15 to 30 patients in each cohort of combination therapy.
Tumor response assessments will be performed using RECIST1.1 and iRECIST at the end of study treatment/early withdrawal visit and every 6 weeks during treatment.
All patients will be followed for safety and survival. The data cut-off date for study is defined as 6 months after the last patient is enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase Ia will be planned in 2 dose groups, Phase Ib will select the optimal dose based Phase Ia | Experimental | Drug: JCXH-211 Intratumoral Injection Combined with Anti-PD-1 Antibody IV infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients, aged 18 to 75 years;
- patients with malignant solid tumors confirmed by pathology and/or cytology who have progressed or are intolerant to standard treatment (except best supportive care); Including patients who have received prior anti-PD-1 antibody therapy; patients who have been approved as eligible for Toripalimab:
- General condition score ECOG 0 ~ 1;
- Expected survival of more than 3 months;
Key exclusion criteria (3 listed)
- Known or suspected allergy to the ingredients of the study drug or its analogues; allergic history to another monoclonal antibody;
- patients who have previously received IL-12 therapy (alone or as part of a treatment regimen), except those who have participated in tolerance to a single intratumoral injection;
- patients who have previously received treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or have received treatment directed at another stimulatory or coinhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137), and discontinued treatment due to Grade 3 or higher immune-related adverse events (irAEs);
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 Intratumoral Injection Combined with Anti-PD-1 Antibody IV infusionJCXH-211:Tumor lesions are selected for intratumoral injection, and target or non-target lesions can be selected. The number of lesions selected for injection will be at the investigator 's discretion based on the patient' s general condition and tolerability . Anti-PD-1 antibody:Dosage and administration according to the instructions. | Drug | Phase Ia will be planned in 2 dose groups, Phase Ib will select the optimal dose based Phase Ia |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: The DLT observation period is 28 days after first dose of JCXH-211 combined with anti-PD-1 antibody
Results and safety
This study is still under way. Results are not available in the source record yet.
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.
RuiHua Xu principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JCXH-211 Intratumoral Injection Combined with Anti-PD-1 Antibody IV infusion in people with Malignant Solid Tumors, run by Immorna Biotherapeutics, Inc. at 1 site in China.
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 4 inclusion and 3 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: looking for participants now, 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 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact RuiHua Xu (86-20-87343468, xurh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: The DLT observation period is 28 days after first dose of JCXH-211 combined with anti-PD-1 antibody). 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.