Personalized Neoantigen-pulsed Autologous Dendritic Cell Injections for Malignant Solid Tumors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZSky Biotech Inc
About this trial
This is a prospective, single-center, open-label, real-world clinical study designed to evaluate the safety, efficacy, and immunogenicity of Personalized neoantigen-pulsed autologous dendritic cell Injections （ZSNeo-DC）in patients with malignant solid tumors. The study protocol received approval from the institutional review board and ethics committee of Beidaihe Hospital, adhering to ethical guidelines. Written informed consent was obtained from all participants in accordance with the principles of the Declaration of Helsinki. Approximately 100 patients will be enrolled in multiple tumor-specific cohorts which will be independently statistically analyzed. ZSNeo-DC will be manufactured by Good Manufacturing Practice (GMP). Participants will receive seven subcutaneous injections of personalized DCs administered on Days 1, 8, 15, 22, 36, 50, and 64, either as monotherapy or in combination with immune checkpoint inhibitors according to routine clinical practice. Tumor response, progression-free survival, overall survival, safety, and antigen-specific immune responses will be evaluated throughout the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female participants aged 18 to 75 years, inclusive.
Histologically or cytologically confirmed malignant solid tumor.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Availability of sufficient tumor tissue and peripheral blood samples for whole-exome sequencing (WES), RNA sequencing (RNA-seq), and neoantigen identification.
Disqualifiers
T-cell-derived malignant tumors.
Previous allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
Active autoimmune disease requiring systemic treatment.
Active uncontrolled bacterial, viral, fungal, or opportunistic infection.
Trial design
Design model
Single group
Treatments tested in this trial
Personalized neoantigen-pulsed autologous dendritic cell Injections （ZSNeo-DC）
Biological/VaccinePersonalized neoantigen-pulsed autologous dendritic cell Injections （ZSNeo-DC）will be manufactured by Good Manufacturing Practice (GMP). Mature dendritic cells are administered by subcutaneous injection to induce tumor-specific immune responses.
Immune Checkpoint Inhibitors
DrugApproved immune checkpoint inhibitors may be administered according to the approved prescribing information and institutional clinical practice.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Personalized Dendritic Cell InjectionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR)
Objective tumor response will be evaluated according to RECIST version 1.1 or other disease-specific response criteria, as applicable.
Time frame
From first study treatment until 12 months after treatment initiationSecondary outcomes
1
Overall Survival
Time frame
From first treatment until death from any cause, assessed up to 24 months.2
Disease Control Rate
Time frame
Up to 12 months.3
Best Overall Response
Time frame
Up to 12 months.4
Clinical Benefit Rate
Time frame
Up to 12 months.Other outcomes
1
Antigen-specific T-cell Response
Antigen-specific T-cell activation will be evaluated using immunological assays including ELISPOT and flow cytometry.
Time frame
Baseline, Day 22, Day 64, and disease progression/end of study (up to 24 months)2
Change in Peripheral Immune Cell Subsets
Changes in peripheral immune cell populations, including T-cell subsets and other immune-related cell populations, following personalized dendritic cell therapy will be assessed. Results will be reported as changes from baseline in immune cell proportions or absolute counts.
Time frame
Baseline, Day 22, Day 64, and disease progression/end of study (up to 24 months)Sponsors and contacts
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Source ClinicalTrials.gov