The Fourth Generation CART-cell Therapy for Refractory-Relapsed Ovarian Cancer

NCT03814447 | Unknown Early Phase 1 DMC

• 1 other identifier: MESO-CART
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to study the safety and feasibility of anti- Mesothelin Chimeric Antigen Receptor T-Cell (MESO CAR-T cells) therapy for Refractory-Relapsed Ovarian Cancer

Conditions

Ovarian Cancer

Keywords

MESO; CAR-T; Ovarian cancer; Refractory-Relapsed

Outcome Measures

Primary Outcomes (1)

• Adverse events (AEs) and Serious adverse event (SAEs)

  Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.03

  1 year post infusion

Secondary Outcomes (7)

• Cmax

  30 days post infusion

• Tmax

  30 days post infusion

• AUC(0-30d)

  30 days post infusion

• Duration of Mesothelin-positive T cells in circulation

  90 days post infusion

• ORR

  3 months post infusion

Study Arms (1)

anti- MESO CAR-T cells

EXPERIMENTAL

The subjects in this arm will receive Cyclophosphamide 300mg/m2/d and Fludarabine 30mg/m2/d d-4\~-2. Then anti- MESO CAR-T cells will be injected by a dose of 5×106/kg once at d1(rang from d1-3).

Drug: anti- MESO CAR-T cells; Drug: Fludarabine; Drug: Cyclophosphamide

Interventions

anti- MESO CAR-T cells DRUG

Autologous genetically modified anti- MESO CAR transduced T cells

anti- MESO CAR-T cells

Fludarabine DRUG

Dose: 30mg/m2/d

Also known as: FA

anti- MESO CAR-T cells

Cyclophosphamide DRUG

Dose: 300mg/m2/d

Also known as: CTX

anti- MESO CAR-T cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathologically confirmed ovarian cancer;
• Years Old, female;
• Expected survival \> 12 weeks;
• Eastern Cooperative Oncology Group (ECOG) score 0-2;
• Patients who have previously been treated with second- line or above standard treatment are failed (progress in treatment or recurrence within 6 months after discontinuation of treatment);
• According to the Immune-Modified Response Evaluation Criteria In Solid Tumors (imRECIST) , there should be at least one measurable tumor foci；
• Positive expression of Mesothelin in tumor tissue；
• Creatinine ≤ 1.5×ULN or creatinine clearance ≥ 60ml / min;
• alanine aminotransferase and aspartate aminotransferase ≤ 2.5×ULN , such as with liver metastasis, ≤ 5×ULN;
• Total bilirubin ≤ 2×ULN;
• Hemoglobin≥90g/L(No blood transfusion within 14 days);
• Absolute value of neutrophils ≥1.5×10\^9/L;
• Absolute counting of lymphocytes \>0.7×10\^9/L;
• Counting of Platelet≥80×10\^9/L；
• The venous access required for collection can be established without contraindications for leukocyte collection;

You may not qualify if:

• Accompanied by other uncontrolled malignant tumors;
• Active hepatitis B, hepatitis C, syphilis, HIV infection;
• Insufficient function of important organs (heart, lung);
• Any other uncontrolled active disease that impedes participation in the trial;
• Any affairs could affect the safety of the subjects or purpose 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 within 14 days or 14 days prior to enrollment；
• The investigator believes that it is not appropriate to participate in the trial;
• Received CAR-T treatment or other gene therapies before enrollment; Subjects suffering disease affect the understanding of informed consent or unable to comply with study; Unwilling or unable to comply with study requirements.

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead
• Hrain Biotechnology Co., Ltd.: collaborator

Study Sites (1)

Shanghai 6th People's Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Hui Zhao, doctor

  Shanghai 6th People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Zhao, doctor

CONTACT

021-64369181; ivy25502@hotmail.com

Yincheng Teng, doctor

CONTACT

021-64369181; teng_yc@126.com

Study Design

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

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 24, 2019
• Study Start: August 16, 2019
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: August 10, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)