CHP-MAGE-A4 vaccine study for MAGE-A4-expressing cancer

CHP-MAGE-A4 vaccine study for MAGE-A4-expressing cancer - CHP-MAGE-A4 vaccine study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001599

Enrollment

Registered

2008-12-25

Start date

2008-12-01

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

MAGE-A4-expressing therapy-resistant cancer (non origin-limited)

Interventions

Subcutaneous injection of CHP-MAGE-A4 protein complex vaccine 100 microgram or 300 microgram,every two weeks, repeated at least six cycles

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.MAGE-A4-expressing therapy-resistant cancer, with clinical stage III or IV, recurrent, metastatic disease, or at high-risk if reccurrence. 2.histoligically confirmed malignant tumor 3.MAGE-A4-antigen expressing. 4.Performance status(ECOG) 0 to 2. 5.Aged twenty or more, male or female 6.At least four-month life expectancy 7.Normal major organ function, and meeting the criteria below White cell counts 2,000/uL or more. Hemoglobin 8.0 g/dl or more. Platelets 75,000/uL or more. Serum bilirubin: within 1.5 times of normal upper level(within 3 times in case of liver damage). AST(GOT)/ALT(GPT): within 2.5 times of normal upper level(within 5 times in case of liver damage). Serum creatinine within 1.5 times of normal upper level. 8.Not willing to be pregnant (both sexes) 9.Having written informed consent.

Exclusion criteria

Exclusion criteria: 1.HIV-positives. 2.Double cancers. 3.Autoimmune disease. 4.History of serious hypersensitivity. 5.Active CNS metastasis. 6.Lasting less than four weeks from the previous chemotherapy, systemic corticostoroid, immuno-suppressive or -stimulating agents, radiotherapy, or surgery to primary tumors 7.Pregnant or lactating. 8.Inappropriate for study entry judged by an attending physician.

Design outcomes

Primary

Measure	Time frame
Safety:maximum-tolerable dose, dose-limting toxicity, profiles of adverse events. Efficacy: MAGE-A4-specific immune responses	—

Secondary

Measure	Time frame
Efficacy:tumor responses, progression-free time, overall survival, response-duration time and time-to-progression	—

Countries

Japan

Contacts

Public ContactShinichi Kageyama

CHP-MAGE-A4 clinical trial registry Cancer vaccine, Mie Universituy

kageyama@clin.medic.mie-u.ac.jp059-231-5280

Outcome results

None listed

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