---
title: Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors
nct_id: NCT05727839
overall_status: COMPLETED
phase: PHASE1
sponsor: Immorna Biotherapeutics, Inc.
study_type: INTERVENTIONAL
primary_condition: Cutaneous Tumor
countries: United States, China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05727839.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05727839"
ct_last_update_post_date: 2026-03-24
last_seen_at: "2026-05-12T07:13:45.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors

**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

**NCT ID:** [NCT05727839](https://clinicaltrials.gov/study/NCT05727839)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 19
- **Lead Sponsor:** Immorna Biotherapeutics, Inc.
- **Conditions:** Cutaneous Tumor, Malignant Solid Tumor
- **Start Date:** 2023-02-24
- **Completion Date:** 2024-09-30
- **CT.gov Last Update:** 2026-03-24

## Brief 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

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Dose escalation** (EXPERIMENTAL) — Dose escalation study of intratumoral injection of JCXH-211 injection into cutaneous/subcutaneous lesions

## Interventions

- **JCXH-211 Injection** (DRUG) — JCXH-211 administered once every 28 days or 14days

## Primary Outcomes

- **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）.

## 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.)_

## Locations (2)

- The George Washington Medical Faculty Associates, Washington D.C., District of Columbia, United States
- Sun Yat-sen University Cancer Center, Guangdong, Guangzhou, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.the george washington medical faculty associates|washington d.c.|district of columbia|united states` — added _(2026-05-12)_
- `locations.sun yat-sen university cancer center|guangdong|guangzhou|china` — added _(2026-05-12)_

---

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