A Clinical Study of Personalized Self-DC Vaccine Targeting Neoantigen in Treatment of Advanced Solid Tumor

NCT06682117 | Recruiting

• 1 other identifier: Neo-DCV-001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical study of personalized self-DC vaccine targeting neo-antigen (Neo-DC vaccine) in the treatment of advanced solid tumors.

Conditions

Treatment; Neoantigen; Vaccine; Solid Tumor Cancer

Keywords

advanced solid tumors; DC vaccine; neoantigen

Outcome Measures

Primary Outcomes (1)

• Adverse events

  The incidence and severity of adverse events

  Within 28 days after the first Neo-DC vaccine cell infusion

Secondary Outcomes (2)

• Objective response rate (ORR)

  up 2 years

• Dose limited toxicity

  Within 28 days after the first Neo-DC vaccine cell infusion

Other Outcomes (4)

• IFN-γ activity detected by ELISPOT, cell factor and T cell subsets detection.

  up 2 years

• iDCR

  up 2 years

• iPFS

  up 2 years

Study Arms (1)

treatment arm

EXPERIMENTAL

Patients will received DC vaccine infusions.

Drug: DC Vaccine

Interventions

DC Vaccine DRUG

Patients will receive Neo-DC vaccine infusion either by dose 1 (1×10\^7 cells/time) or dose 2 (5×10\^7 cells/time) every 7 days, four cell infusions are one treatment cycle. The dose limited toxity observation time is within 28 days after the first Neo-DC vaccine infusion. If the efficacy is evaluated as clinical benefit (CR/PR/SD) or immune unconfirmed progress ( iUPD), treatment cycle can be continued until the completion of four Neo-DC vaccine administrations or disease progression (iCPD by iRECIST) or start new anti-tumor treatment or stop treatment by other reasons.

treatment arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years.
• Histologically or cytologically confirmed advanced solid tumor, with at least one tumor lesion measurable (basis RECIST1.1 standard).
• HLA typing was HLA-A0201/1101/2402 (containing at least one of the typing, according to the central laboratory issued).
• Paraffin-embedded tumor tissue sections or biopsy tumor tissues within 3 years (for tumors with easy sampling).
• Before enrollment, systemic standard treatment failure or standard treatment intolerance, and meet the following tumor requirements : new antigen positive（head and neck tumors, non-small cell lung cancer without driver genes (no EGFR sensitive mutation / ALK fusion positive), esophageal squamous cell carcinoma).
• Voluntary to participate in clinical research ; the person or legal guardian fully understands and is informed of this study and sign the informed consent; willing to follow and be able to complete all test procedures;
• ECOG score 0-1.
• Have a venous access to meet single collection or venous blood collection;
• Expected survival time ≥ 6 months.
• Subjects were willing to study the use of reliable contraceptive methods during treatment and within 3 months after the end of treatment, and women of childbearing age.
• Have adequent organ functions.
• Before administration of Neo-DCV injection : 1) any chemotherapy, targeted drugs, immune checkpoint inhibitors, other clinical trial research drugs, traditional Chinese medicine with anti-tumor indications and other anti-tumor treatments received have passed the 4-week elution period, and the toxic and side effects returned to grade 1 or lower (except for alopecia, vitiligo and other tolerable events judged by researchers) ; 2) If undergoing major surgery within 3 weeks, the adverse reactions have returned to grade 1 or lower.

You may not qualify if:

• Pregnant or lactating women.
• Patients with a history of severe immediate allergies to the cells and any drugs used in this study.
• Those with a history of organ transplantation.
• Known central nervous system metastasis.
• Any active autoimmune disease or any autoimmune disease that has been determined by the researchers to be unsuitable for this study.
• Uncontrolled concomitant diseases or infectious diseases, such as the need for systemic antibiotics within 2 weeks before enrollment.
• Subjects planned to receive sugar within 4 weeks before the first Neo-DCV injection and during the study period due to certain conditions.
• Corticosteroids (prednisone or the same drug dose less than 10mg/day ) or other immunosuppressive agents were excluded.
• Subjects were scheduled to receive Neo-DCV injection within 4 weeks before the first administration and during the study period due to certain conditions.
• The researchers assessed that the subjects were unable or unwilling to comply with the requirements of the study protocol.
• The defects of antigen presentation, antigen recognition and cell killing related genes were detected by sequencing.
• There was a history of other malignant tumors in the past 5 years, except for curable basal cell carcinoma, papillary thyroid carcinoma, and uterus.
• Subjects have any disease or medical condition that may affect the evaluation of the safety or efficacy of the study drug.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200020, China

RECRUITING

MeSH Terms

Interventions

lentiviral minigene vaccine of COVID-19 coronavirus

Study Officials

• Xianghua Wu, M.D

  Fudan University

  PRINCIPAL INVESTIGATOR

• Qinghai Ji, M.D

  Fudan University

  PRINCIPAL INVESTIGATOR

• Dongmei Ji, M.D

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongmei Ji, M.D

CONTACT

021-64175590; jidongmei2000@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: This is a single arm, single center, open label study designed as \"3+3\" model to explore the MTD and DLT of personalized self-DC vaccine targeting neoantigen in treatment of advanced solid tumor.

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: November 12, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)