One Trial of JCXH-211 Intratumoral Injection Combined With Anti-PD-1 Antibody in Patients With Malignant Solid Tumors

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorImmorna Biotherapeutics, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

Male or female patients, aged 18 to 75 years;

General condition score ECOG 0 ~ 1;

Expected survival of more than 3 months;

Disqualifiers

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 design

Treatments tested in this trial

  • JCXH-211 Intratumoral Injection Combined with Anti-PD-1 Antibody IV infusion

Treatment groups

72 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators