Personalized neoantigen-pulsed dendritic cell injections for malignant solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center, open-label study evaluating the safety, immunogenicity, and potential efficacy of personalized neoantigen-pulsed autologous dendritic cell injections in patients with malignant solid tumors. Approximately 100 participants across tumor-specific cohorts will receive seven subcutaneous injections on scheduled days, with optional combination to checkpoint inhibitors per standard practice. Dendritic cells are manufactured under GMP conditions and the trial includes careful tumor and blood sampling for sequencing to identify neoantigens. Outcomes will be analyzed within each tumor cohort, following ethical approvals and informed consent.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants must meet all of the following criteria:

  1. Male or female participants aged 18 to 75 years, inclusive.
  2. Histologically or cytologically confirmed malignant solid tumor.
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  4. Adequate hematologic function, including:
  5. Adequate hepatic function:
  6. Adequate renal function:
  7. Adequate coagulation function:
  8. Adequate pancreatic function:
  9. Availability of sufficient tumor tissue and peripheral blood samples for whole-exome sequencing (WES), RNA sequencing (RNA-seq), and neoantigen identification.
  10. Adequate peripheral venous access for peripheral blood mononuclear cell (PBMC) collection by leukapheresis.
  11. Left ventricular ejection fraction (LVEF) ≥50%.
  12. Estimated life expectancy of at least 3 months.
  13. Women of childbearing potential must have a negative pregnancy test within 7 days before the first administration of study treatment.
  14. Male participants and women of childbearing potential must agree to use highly effective contraception during treatment and for 3 months after the final administration.
  15. Ability to understand and voluntarily sign written informed consent.
  16. Willingness and ability to comply with study procedures and scheduled follow-up assessments.

Exclusion Criteria:

* Participants meeting any of the following criteria will be excluded:

  1. T-cell-derived malignant tumors.
  2. Previous allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
  3. Active autoimmune disease requiring systemic treatment.
  4. Active uncontrolled bacterial, viral, fungal, or opportunistic infection.
  5. Known human immunodeficiency virus (HIV) infection.
  6. Active hepatitis B or hepatitis C infection that is not adequately controlled.
  7. Clinically significant cardiovascular disease, including uncontrolled hypertension, unstable angina, myocardial infarction within 6 months, severe arrhythmia, or congestive heart failure.
  8. Severe pulmonary, hepatic, renal, neurologic, psychiatric, or other uncontrolled systemic diseases judged by the investigator to interfere with study participation.
  9. Pregnant or breastfeeding women.
  10. Receipt of systemic immunosuppressive therapy within 14 days before leukapheresis, except physiologic corticosteroid replacement.
  11. Receipt of blood transfusion, erythropoietin, granulocyte colony-stimulating factor (G-CSF), or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 14 days before PBMC collection.
  12. Inability to undergo leukapheresis.
  13. Any condition that, in the investigator's opinion, would place the participant at unacceptable risk or compromise study integrity.

Where it's running

• Beidaihe Hospital of Qinhuangdao
  Qinhuangdao, Hebei, China Recruiting

Study contacts

• Study coordinator: Xiaomin Ma, M.M
• Email: xiaomin.ma@zskybio.com
• Phone: +0518-82342973

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Testing a new treatment for advanced solid tumors

  This study is testing a new treatment called tolododekin alfa for people with advanced solid tumors that haven't improved with standard therapies to see how safe it is and how well it works.

  Recruiting at 5 sites Phase 1 Ankyra Therapeutics, Inc · Bethesda, Maryland and 4 other locations · NCT06171750

• SGT003 in people with advanced solid tumors

  This early-phase study tests SGT003 in adults with advanced solid tumors to see if it is safe and tolerable and to get a first look at how it behaves in the body and any early signs of benefit.

  Recruiting Phase 1/2 Beijing Sungen Biomedical Technology Co., Ltd · Beijing, Beijing Municipality · NCT07811037

• YSCH-01 Nebulized Therapy for Lung Metastases in NSCLC and Advanced Solid Tumors

  A first-in-human, early-phase study tests a nebulized therapy called YSCH-01 to see if it is safe and shows any signs of benefit for adults with NSCLC or other cancers that have spread to the lungs.

  Recruiting Early Phase 1 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing · NCT07793500

• STX-003 in advanced solid tumors given by IV, alone or with pembrolizumab

  This study tests STX-003, given by IV, to see if it is safe and potentially effective for patients with advanced solid tumors, either alone or with pembrolizumab.

  Recruiting at 4 sites Phase 1/2 Strand Therapeutics Inc. · Scottsdale, Arizona and 3 other locations · NCT07751042

• ARV-6723 alone or with pembrolizumab in adults with advanced solid tumors

  This study tests ARV-6723, by itself or with pembrolizumab, to see if it is safe and could help the immune system fight advanced solid tumors in adults.

  Recruiting at 4 sites Phase 1/2 Arvinas Inc. · New York, New York and 3 other locations · NCT07749586

• BG-85738 alone or with other anticancer drugs in RAS-mutant advanced or metastatic solid tumors

  This study tests BG-85738, alone or with other cancer drugs, in adults whose solid tumors have RAS mutations and have progressed.

  Recruiting at 3 sites Phase 1 BeOne Medicines · South Brisbane, Queensland and 2 other locations · NCT07746141

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.