MESO-CAR T Cells Therapy for Relapsed and Refractory Epithelial Ovarian Cancer

NCT03916679 | Unknown Phase 1

• 1 other identifier: MESO-OS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer; CAR-T; MESO; Relapsed and Refractory

Outcome Measures

Primary Outcomes (1)

• Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0

  12 months post infusion

Secondary Outcomes (4)

• Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm

  12 months post infusion

• Progress Free Survival (PFS) after administration

  12 months post infusion

• Duration of CAR-positive T cells in circulation

  12 months post infusion

• Detection of PD1 antibody in serum

  12 months post infusion

Study Arms (1)

anti-MESO CAR-T cells

EXPERIMENTAL

Administration with anti-MESO CAR-T cells in the MESO-positive ovarian cancer patients

Biological: anti-MESO CAR-T cells

Interventions

anti-MESO CAR-T cells BIOLOGICAL

Retroviral vector-transduced autologous T cells to express anti-MESO CARs

Also known as: Fludarabine 30mg/m2/d, Cyclophosphamide 300mg/m2/d

anti-MESO CAR-T cells

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Recurrence

Interventions

fludarabine; Cyclophosphamide

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Jianwei Zhou, M.D.

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Central Study Contacts

Zhigang Zhang, M.D.

CONTACT

15088621550; zzg2011@zju.edu.cn

Jianwei Zhou, M.D.

CONTACT

0571-89713634; jianwei-zhou@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 16, 2019
• Study Start: April 20, 2019
• Primary Completion: April 20, 2022
• Study Completion: April 20, 2023
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

CN (1)