The prospective,multi-center and single arm clinical study of CAR-T cell treatment for recurrent or refractory ovarian cancer

• Register: ChiCTR
• Last refreshed on: 30 April 2018
• Main ID: ChiCTR1800015678
• Date of registration: 2018-04-14
• Prospective Registration: Yes
• Primary sponsor: Xuefeng Wang
• Public title: The prospective,multi-center and single arm clinical study of CAR-T cell treatment for recurrent or refractory ovarian cancer
• Scientific title: The prospective,multi-center and single arm clinical study of CAR-T cell treatment for recurrent or refractory ovarian cancer
• Date of first enrolment: 2018-06-01
• Target sample size: mesothelin group:20;PSMA group:20;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=26454
• Study type: Observational study
• Study design: Case series
• Phase: New Treatment Measure Clinical Study

Countries of recruitment

China

Contacts

• Name: Xuefeng Wang
• Affiliation: ZhuJiang Hospital of Southern Medical University

• Name: Xuefeng Wang
• Affiliation: ZhuJiang Hospital of Southern Medical University

Key inclusion & exclusion criteria

Inclusion criteria: (1) Subject and/or guardian should sign a written consent before trial begin;
(2) Subject should be female of 10 years or older;
(3) Performance status(PS) of Eastern Cooperative Oncology Group(ECOG) of subject scores 0~1;
(4) The life expectancy of subject should be more than three months;
(5) The immunohistochemical staining of target molecule mesothelin or PSMA in the subject's ovarian cancer samples should not be less than ++;
(6) Subject should comply fully with the protocol specification.
(7) The histological result of subject should be in accordance with the following conditions for clinical staging of primary ovarian cancer (FIGO):
FIGO I-IIa(only in grade 3/low differentiation); FIGO IIb-IV(any grade) of epithelial ovarian cancer, fallopian tube cancer and primary peritoneal carcinoma; Regardless of FIGO, the histological result is epithelial cell carcinoma (more than 50% epithelial cell which was diagnosed by local pathologists); Histologic result is cancer sarcoma; Patients with recurrent ovarian cancer have accepted surgery at the early stage;
(8) Subject should not be pregnant, proper birth control measures should be done if the subject was fertile;
(9) The hematopoietic function of subject should fulfil the following conditions:
The absolute neutrophil count (ANC) in the blood is more than 1,000/mm3; The platelets in the blood is more than 100,000/ mm3;
(10) Subject should have good liver function and kidney function:
Creatinine is no more than twice the upper normal limit; Bilirubin is no more than twice the upper normal limit; Aspartate aminotransferase (AST)/alanine transaminase (ALT) is no more than twice the upper normal limit; Alkaline phosphatase (ALKP) is no more than 5 times the upper normal limit; Total bilirubin value of 2 is acceptable range in patients with Gilbert's syndrome.
(11) Subject's ejection fraction should be more than 45%;
(12) Subject should be infected with human immunodeficiency virus (HIV) and hepatitis C virus (HCV).
Exclusion criteria: (1)Subject has the following situations:
Non-epithelial ovarian cancer; Low-malignant ovarian tumor(such as borderline tumor); Multiple primary endometrial cancer, and the following criteria are related to endometrial cancer: FIGO=IA; Non-myometrial invasion; Non-lymphatic vessel invasion; Non-low differentiation(grade 3, mastoid serous or transparent cell carcinoma);
(2) The free gas in abdominal cavity of subject is demonstrates that which is not caused by paracentesis or the surgical operation of prior, present or planned treatment;
(3) Subject is receiving treatment of antibody for CA-125;
(4) Subjects is currently or recently (28 days before the first infusion) received treatment for other research drugs, or had previously participated in the study;
(5) Subject is currently or recently (10 days before the first infusion) treated with aspirin at a daily dose of more than 325mg;
(6) Subject receives minor surgery 2 days before the first infusion;
(7) The pregnancy test of subject is positive;
(8) Subject has abnormal hematopoietic function:
Absolute neutrophils in blood (ANC) < 1,000 /mm3; Platelets in the blood <100,000/mm3; Hemoglobin <9 g/dL;
(9) Subject has abnormal liver or renal function:
Total Bilirubin >1.5 times the upper normal limit; Aspartate aminotransferase (AST)/alanine transaminase (ALT)>2.5 times the upper normal limit; Alkaline phosphatase (ALKP)>2.5 times the upper normal limit; Total bilirubin value of 2 is acceptable range in patients with Gilbert's syndrome; Creatinine>2mg/dL or (>177µmol/L); The urine protein should be less than 2+ (if not, urine should be collected again after 24hr, and the urine protein must be tested less than 1g/24hr);
(10) Subject need to take antibiotics if seriously infected during screen pahse;
(11) Subject is infected with HCV(the HCV antibody is positive), or HBV(The HBV surface antigen is positive), or HIV(The HIV antibody is positive), or HTLV(The HTLV antibody is positive), or Treponema pallidum (Treponema pallidum antibody is positive) or TB(TB strains culture is positive);
(12) The immunohistochemical staining of target molecule mesothelin or PSMA in the subject's ovarian cancer samples is less than ++.

Age minimum: 10
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

ovarian cancer

Intervention(s)

mesothelin group:inject mesothelin-targeted OC-IgT;PSMA group:inject PSMA-targeted OC-IgT;

Primary Outcome(s)

CA125;tumor size;quality of life;

Secondary Outcome(s)

blood routine examination;hepatic and renal function;

Source(s) of Monetary Support

self-raised funds

Ethics review

Status: Approved
Approval date: 30/03/2018
Contact:

[e-mail]

Wei Guo

[phone]

[e-mail]