Clinical trial NCT03916679: MESO-CAR T Cells Therapy for Relapsed and Refractory Epithelial Ovarian Cancer
Official title: Safety and Effectiveness of MESO-CAR T Cells Therapy for Relapsed and Refractory Epithelial Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Ovarian Cancer
Keywords: Ovarian Cancer
CAR-T
MESO
Relapsed and Refractory
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to study the feasibility and efficacy of anti-MESO antigen receptors (CARs) T cell therapy for relapsed and refractory epithelial ovarian cancer.

Detailed description: Primary Objectives

To determine the feasibility ad safety of anti-MESO CAR-T cells in treating patients with MESO-positive ovarian cancer.

Secondary Objectives

To access the efficacy of anti-MESO CAR-T cells in patients with ovarian cancer.

To determine in vivo dynamics and persistency of anti- MESO CAR-T cells.

Eligibility criteria: Inclusion Criteria:

- 18 to 70 Years Old, female; Expected survival \> 12 weeks; Clinical performance status of ECOG score 0-2; Patients who have previously been treated with second- line or more lines of standard treatment are not effective (No remission or recurrence after remission); At least one measurable tumor foci according to RECIST standard 1.1 ; Positive Mesothelin expression in tumor tissues; Creatinine ≤ 1.5×ULN; ALT and AST ≤ 3×ULN; Total bilirubin ≤ 2×ULN; Hemoglobin≥90g/L; Absolute counting of neutrophils≥1000uL ; Absolute counting of lymphocytes\>0.7×10\^9/L; Counting of Platelet≥75000/uL; The venous access required for collection can be established without contraindications for leukocyte collection; Able to understand and sign the Informed Consent Document.

Exclusion Criteria:

- Accompanied by other uncontrolled malignant tumors; Active hepatitis B, hepatitis C, syphilis, HIV infection; Suffering severe cardiovascular or respiratory disease; Any other diseases could affect the outcome of this trial; Any affairs could affect the safety of the subjects or outcome of this trial; Pregnant or lactating women, or patients who plan to be pregnancy during or after treatment; There are active or uncontrollable infections (except simple urinary tract infections or upper respiratory tract infections) that require systemic therapy 14 days or 14 days prior to assignment; Patients who are accounted by researchers to be not appropriate for this test; Received CAR-T treatment or other gene therapies before assignment; Subject suffering disease affects the understanding of informed consent or comply with study protocol.

Primary outcomes:
measure: Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
timeFrame: 12 months post infusion
Secondary outcomes:
measure: Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm
timeFrame: 12 months post infusion
measure: Progress Free Survival (PFS) after administration
timeFrame: 12 months post infusion
measure: Duration of CAR-positive T cells in circulation
timeFrame: 12 months post infusion
measure: Detection of PD1 antibody in serum
timeFrame: 12 months post infusion
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jianwei Zhou, M.D.
role: STUDY_CHAIR
References: