NCT03362606

Brief Summary

This is a single-arm, open-label, phase I/II trial to evaluate the safety and efficacy of ovarian cancer specific cytotoxic lymphocytes (OC-CTLs) in women.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1 ovarian-cancer

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

1.2 years

First QC Date

November 20, 2017

Last Update Submit

September 18, 2019

Conditions

Ovarian Cancer

Keywords

Ovarian cancerCytotoxic lymphocyteOC-CTL

Outcome Measures

Primary Outcomes (1)

  • Safety of OC-CTLs in patients using CTCAE version 4.0 standard to evaluate the level of adverse events

    Physiological parameter (measuring cytokine response, fever, symptoms)

    6 months

Secondary Outcomes (2)

  • Functional analyses of OC-CTLs in vitro

    4 weeks

  • Anti-tumor effects

    1 year

Study Arms (1)

OC-CTLs

EXPERIMENTAL

Autologous ovarian cancer specific cytotoxic lymphocytes

Biological: OC-CTLs

Interventions

OC-CTLsBIOLOGICAL

2 to 4 infusions, once a week, for 1x10\^5\~4x10\^6 CTLs/kg via IV, abdominal cavity or tumor injection each time

OC-CTLs

Eligibility Criteria

Age10 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Written, informed consent obtained prior to any study-specific procedures.
  • Age older than 10 years.
  • Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
  • Expected survival ≥ 12 weeks.
  • Histologically confirmed and documented high risk International Federation of Gynecology and Obstetrics (FIGO): Stage II-IV.
  • Not pregnant, and on appropriate birth control if of childbearing potential.
  • Initial hematopoietic reconstitution with
  • neutrophils (ANC) ≥ 1,000/mm\^3;
  • platelet (PLT) ≥ 100,000/mm\^3.
  • Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with
  • serum creatinine ≤ 2×ULN;
  • serum bilirubin ≤ 2×ULN;
  • AST/ALT ≤ 2×ULN;
  • ALKP ≤ 5×ULN;
  • serum bilirubin. 2.0 is acceptable in the setting of known Gilbert's syndrome.
  • +1 more criteria

You may not qualify if:

  • Patients with ovarian tumors with low malignant potential (i.e. borderline tumors);
  • Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure (prior, current or planned treatment).
  • Previous treatment of adoptive T cell therapy.
  • Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug
  • Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations).
  • Pregnant or lactating females.
  • Inadequate bone marrow function with
  • absolute neutrophil count \< 1,000/mm\^3;
  • platelet count \< 100,000/mm\^3;
  • Hb \< 9 g/dL.
  • Inadequate liver and renal function with
  • serum (total) bilirubin \> 1.5 x ULN;
  • AST \& ALT \> 2.5 x ULN (\> 5 x ULN in patients with liver metastases);
  • alkaline phosphatase \> 2.5 x ULN;
  • serum creatinine \>2.0 mg/dl (\> 177 μmol/L);
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Jinshazhou Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, 510415, China

RECRUITING

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

RECRUITING

Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center

Kunming, Yunnan, 650000, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Lung-Ji Chang, PhD

    Shenzhen Geno-Immune Medical Institute

    PRINCIPAL INVESTIGATOR

  • Qichun Cai, MD

    Jinshazhou Hospital of Guangzhou University of Chinese Medicine

    STUDY DIRECTOR

  • Xun Lai, MD

    Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center

    STUDY DIRECTOR

Central Study Contacts

Lung-Ji Chang, PhD

CONTACT

86-075586725195c@szgimi.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

November 20, 2017

First Posted

December 5, 2017

Study Start

November 15, 2017

Primary Completion

January 31, 2019

Study Completion

December 1, 2020

Last Updated

September 19, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)