Intraperitoneal injection of in vitro expanded Gamma Delta T cells together with zoledronate for the treatment of malignant ascites to ovarian cancer ; to evaluate the safety and efficacy. (A Phase 1/2a study)

Intraperitoneal injection of in vitro expanded Gamma Delta T cells together with zoledronate for the treatment of malignant ascites to ovarian cancer ; to evaluate the safety and efficacy. (A Phase 1/2a study) - Intraperitoneal injection of in vitro expanded Gamma Delta T cells together with zoledronate for the treatment of malignant ascites to ovarian cancer ; to evaluate the safety and efficacy. (A Phase 1/2a study)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015233

Enrollment

Registered

2014-09-24

Start date

2014-09-24

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

Ovarian cancer,tubal carcinoma, primary peritoneal cancer

Interventions

Patients undergo leukapheresis for the harvest of peripheral blood mononuclear cells (PBMCs). PBMCs are stimulated with 2-methyl-3-butenyl-1-pyrophosphate and interleukin-2 and cultured for 14 days. P

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1)Aged=>20 years 2)Patients with histologically or cytologically proven ovarian cancer, tubal carcinoma or primary peritoneal cancer 3)Patients who havemalignant ascites 4)ECOG performance status 0-2 5)Leukocyte count => 3,000/mm3 ANC =>1,500/mm3 Platelet count =>100,000/mm3 Serum creatinine => 2.0 mg/dL Serum bilirubin => 2.0 mg/dL AST/ALT =>2.5 times normal LDH => 1.5 times normal PT/APTT => 1.5 times normal 6)Life expectancy =>4 months 7)Patients who voluntarily provided written consent to participate in this trial after having been thoroughly briefed and informed of its nature were eligible for enrollment.

Exclusion criteria

Exclusion criteria: 1)Patients who positive for anti-adult T-cell leukemia-associated antigen or anti-human immunodeficiency virus antibody,or hepatitis. 2)Patients who have uncontrolled infection 3)Patients receiving immunodepressant 4)Patient who were pregnant or lactating 5)Other patients judged to be ineligible by the attending investigators

Design outcomes

Primary

Measure	Time frame
Safety of i.p. injection of autologous Gamma Delta T cells.	—

Secondary

Measure	Time frame
Puncture-free-survival,QOL and immunological proof-of-concept of antitumor activity.	—

Countries

Japan

Contacts

Public ContactYuki Abe

Tokyo Women's Medical University Hospital Obstetrics and Gynecology

yuki_a925_thanks@yahoo.co.jp+81-3-3533-8111

Outcome results

None listed

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