Ovarian CancerEarly Phase 1NCT03799913
MESO-CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer
A Early Phase 1 study testing anti-MESO CAR-T cells, Fludarabine and Cyclophosphamide in people with Ovarian Cancer, run by Zhejiang University at 1 site in China.
Trial 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 ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- anti-MESO CAR-T cells, Fludarabine and Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2019to Apr 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 15Show fewer
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Jianwei Zhou, M.D., 0571-89713634, jianwei-zhou@163.com
About this study
Official title: A Clinical Trial of MESO-CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer
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 ovarian cancer.
Read the detailed description
Primary Objectives
1.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.
- Conditions
- Ovarian Cancer
- Being tested
- anti-MESO CAR-T cells, Fludarabine, Cyclophosphamide
- Keywords
- CAR-T, MESO, Ovarian Cancer, Relapsed and Refractory
- Medical subject headings
- Ovarian Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-MESO CAR-T cellsBiological
Retroviral vector-transduced autologous T cells to express anti-MESO CARs
FludarabineDrug
30mg/m2/d
CyclophosphamideDrug
300mg/m2/d
| Study group | Role | What they receive |
|---|---|---|
| anti-MESO CAR-T cells | Experimental | Administration with anti-MESO CAR-T cells in the MESO-positive ovarian cancer patients Receives: Biological: anti-MESO CAR-T cells; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Measured: 1 years post infusion
Secondary outcomes (4)
Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm
Measured: 12 months post infusion
Progress Free Survival (PFS) after administration
Measured: 12 months post infusion
Duration of CAR-positive T cells in circulation
Measured: 12 months post infusion
Detection of PD1 antibody in serum
Measured: 12 months post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start10 Apr 2019 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Hrain Biotechnology Co., Ltd.
- Responsible party
- Principal investigator, Zhigang Zhang, Zhejiang University
- Investigators
- Jianwei Zhou, M.D., Study chair, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799913
- Sponsor's protocol ID
- MESO
- Status last verified
- Apr 2019
- First submitted
- 8 Jan 2019
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of MESO-CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03799913
- Acronym / sponsor ID
- MESO
- Conditions
- Ovarian Cancer
- Keywords
- CAR-T, MESO, Ovarian Cancer, Relapsed and Refractory
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Hrain Biotechnology Co., Ltd.
- Study start
- 10 Apr 2019 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 10 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ovarian cancer.
Detailed description
Primary Objectives
1.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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anti-MESO CAR-T cells | Experimental | Biological: anti-MESO CAR-T cells, Drug: Fludarabine, Drug: CyclophosphamideAdministration with anti-MESO CAR-T cells in the MESO-positive ovarian cancer patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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 ;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-MESO CAR-T cellsRetroviral vector-transduced autologous T cells to express anti-MESO CARs | Biological | anti-MESO CAR-T cells |
| Fludarabine30mg/m2/d | Drug | anti-MESO CAR-T cells |
| Cyclophosphamide300mg/m2/d | Drug | anti-MESO CAR-T cells |
Primary outcome
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Time frame: 1 years post infusion
4 secondary outcomes
Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm
Time frame: 12 months post infusion
Progress Free Survival (PFS) after administration
Time frame: 12 months post infusion
Duration of CAR-positive T cells in circulation
Time frame: 12 months post infusion
Detection of PD1 antibody in serum
Time frame: 12 months post infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianwei Zhou, M.D. study chair
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing anti-MESO CAR-T cells, Fludarabine and Cyclophosphamide in people with Ovarian Cancer, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhigang Zhang, M.D. (86+057189713631, zzg2011@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 (time frame: 1 years post infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.