← Back to Search

Virus Therapy

JCXH-211 for Cancer

Phase 1
Waitlist Available
Research Sponsored by Immorna Biotherapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with malignant solid tumors diagnosed by pathology and/or cytology
Male or female patients 18-75
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective for treating malignant solid tumors.

Who is the study for?
Adults aged 18-75 with malignant solid tumors who've exhausted other treatments or have no curative options can join. They must provide tumor samples, have a measurable lesion for injection, and adequate organ function. Excluded are those with prior severe immune reactions to cancer immunotherapy, recent major surgery, current immunosuppressants use, history of certain transplants or autoimmune diseases needing treatment.Check my eligibility
What is being tested?
The trial is testing JCXH-211 as a solo therapy by injecting it directly into the tumors of patients. It's an early-phase study focusing on safety and how well the drug works against various solid cancers.See study design
What are the potential side effects?
Specific side effects aren't listed but may include typical reactions to cancer therapies such as inflammation at the injection site, general discomfort or pain, potential immune system responses and any unique issues related to JCXH-211.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer was confirmed through lab tests.
Select...
I am between 18 and 75 years old.
Select...
My cancer lesion is between 10mm and 80mm, suitable for direct injection.
Select...
My condition worsened on current treatments or I can't tolerate them, and there's no cure.
Select...
My organs and bone marrow are working well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting toxicity
Incidence of adverse events (Safety and Tolerability)
Secondary outcome measures
Disease control rate (DCR)
Duration of response (DOR)
Objective response rate (ORR)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase 1b:Dose expansionExperimental Treatment1 Intervention
JCXH-211 will be delivered by intratumoral injection. The dose to be used will be determined after review of the data from Phase 1a.
Group II: Phase 1a:Dose escalationExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Immorna Biotherapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
493 Total Patients Enrolled

Media Library

JCXH-211 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05539157 — Phase 1
Cancer Research Study Groups: Phase 1a:Dose escalation, Phase 1b:Dose expansion
Cancer Clinical Trial 2023: JCXH-211 Highlights & Side Effects. Trial Name: NCT05539157 — Phase 1
JCXH-211 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05539157 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What positive effects are researchers hoping to observe from this clinical research?

"Per the sponsor, Immorna Biotherapeutics, Inc., the primary outcome evaluated over a period of one month will be dose-limiting toxicity. Additionally, this trial is set to measure two secondary outcomes: time to response (TTR), disease control rate (DCR) and progression-free survival (PFS). TTR pertains to the time from Day 1 until initial documentation of objective result; DCR stands for proportion of patients with CR or PR or stable condition lasting at least 12 weeks; PFS marks length between Day 1 and either death or illness development - whichever comes first."

Answered by AI

Are there any vacancies within this clinical trial?

"According to clinicaltrials.gov, this research endeavour is currently in the process of recruiting individuals for participation. It was first posted on October 18th 2022 and has been recently updated as of November 11th 2022."

Answered by AI

Has JCXH-211 obtained the necessary permissions from the U.S. Food and Drug Administration?

"The risk associated with JCXH-211 is low, as evidenced by its score of 1. This reflects the fact that this drug has only progressed to phase 1 trials and there are limited data points supporting safety and efficacy."

Answered by AI

Are there any criteria that potential participants must meet in order to join the trial?

"This clinical trial is selecting 144 participants within an age range of 18 to 75 who possess cutaneous tumours. In order to be admitted, they must satisfy the following requisites: failure or intolerance to existing therapies; lesions that are between 10 and 80 millimeters long; ability and willingness to provide pre-treatment/post-treatment biopsies; sufficient organ/marrow functionality; malignant solid tumors confirmed via pathology/cytology testing; at least one non-injected tumor lesion per RECIST v1.1 standards; those with treated brain metastases provided specific requirements are met; 4 weeks since last chemotherapy treatment"

Answered by AI

How many individuals are taking part in this research experiment?

"Indeed, the details on clinicaltrials.gov demonstrate that this study is looking for volunteers. It was posted to the website on October 18th 2022 and modified most recently on November 11th of that same year. A total of 144 patients are required from a single medical centre."

Answered by AI

Does the protocol of this trial include those over sixty years old?

"The minimum age for entry into this trial is 18 and the maximum permissible age of enrollment stands at 75."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors
2022. "Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05539157.
~0 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top