A phase 1 study of adoptive immunotherapy using autologous RNF43 peptide pulse dendritic cells and RNF43 peptide specifically activated lymphocytes in patients with advanced solid tumors

A phase 1 study of adoptive immunotherapy using autologous RNF43 peptide pulse dendritic cells and RNF43 peptide specifically activated lymphocytes in patients with advanced solid tumors - RNF43 peptide pulse DC with specifically activated lymphocytes therapy

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003945

Enrollment

Registered

2010-07-25

Start date

2009-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced solid tumors which already have finished available standard therapies.

Interventions

First cohort

five patinets 1.RNF43 peptide specifically activated autologous lymphocytes infusion 5x10^7 cells, single dose, i.v. 2.RNF43 peptide pulse DC administration on day 1,8 and 15 Second cohort

five patinets 1.RNF43 peptide specifically activated autologous lymphocytes infusion 2x10^8 cells, single dose, i.v. 2.RNF43 peptide pulse DC administration on day 1,8 and 15

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Advanced solid tumors which already have finished available standard therapies. 2. Performance status 0-1 (ECOG). 3.HLA-A2402 or A0201-positive status. 4. PCR-confirmed RNF43-antigen expression of tumor cells 5.Having measurable tumor for assessing clinical responses 6.Patients who have recovered from the toxicity of any previous therapy for at least 4 weeks before trial entry. 7.Life expectancy of at least 3 months. 8.Adequate hematological function WBC count more than 3000 /uL, platelet count more than 100000/uL, AST, ALT less than 3 X ULN value, T-Bil less than 2.0mg/dl, s-Cr less than 1.5mg/dl. 9.Negative for hepatitis B antigen, anti-hepatitis C antibody, anti-HIV antibody, anti-HTLV-1 antibody and syphilis serodiagnosis. 10.Written informed consent obtained at the time of enrolment.

Exclusion criteria

Exclusion criteria: 1.Patients with severe pre-exiting diseases :autoimmune diseases, an active infectious diseases, cardiovascular disorders, respiratory disorders, renal dysfunction, immunodeficiency, and hematological disorders. 2.Pregnant, lactating, or possiblly pregnant women, or willing to be pregnant, or willing male partner 3.No active brain metastases. 4.Patients who should receive systemic administration of steroid or immunosuppressive agents. 5.Inappropriate for study entry judged by an attending physician.

Design outcomes

Primary

Measure	Time frame
safety	—

Secondary

Measure	Time frame
clinical efficacy and immunologic monitoring	—

Countries

Japan

Contacts

Public ContactYasuki Hijikata

Kyushu University Hospital Department of Advanced Molecular and Cell Therapy

092-642-5996

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026