Ovarian CancerEarly Phase 1NCT03814447
The Fourth Generation CART-cell Therapy for Refractory-Relapsed Ovarian Cancer
A Early Phase 1 study testing anti- MESO CAR-T cells, Fludarabine and Cyclophosphamide in people with Ovarian Cancer, run by Shanghai 6th People's Hospital at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 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
- 10 participants
- Where
- 1 siteChina
- Study dates
- 16 Aug 2019to Jan 2023
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically confirmed ovarian cancer;
- 18-75 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；
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- 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;
- 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;
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality
Hui Zhao, 021-64369181, ivy25502@hotmail.com
About this study
Official title: The Clinical Research of Fourth Generation CART-cell Therapy in Refractory-Relapsed Ovarian Cancer
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
Read the detailed description
Primary Objectives:
- To determine the safety and feasibility of anti- MESO CAR-T cells therapy for Refractory-Relapsed 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
- To assess the quality of life in patients with ovarian cancer after treatment with anti- MESO CAR-T cells.
- Conditions
- Ovarian Cancer
- Being tested
- anti- MESO CAR-T cells, Fludarabine, Cyclophosphamide
- Keywords
- MESO, CAR-T, Ovarian cancer, Refractory-Relapsed
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti- MESO CAR-T cellsDrug
Autologous genetically modified anti- MESO CAR transduced T cells
FludarabineDrug
Also called FA
Dose: 30mg/m2/d
CyclophosphamideDrug
Also called CTX
Dose: 300mg/m2/d
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: 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.
Adverse events (AEs) and Serious adverse event (SAEs)
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.03
Measured: 1 year post infusion
Secondary outcomes (7)
Cmax
the highest concentration (Cmax) of anti-human MESO T cells in the peripheral blood after administration
Measured: 30 days post infusion
Tmax
the time to reach the highest concentration (Tmax) of anti-human MESO T cells in the peripheral blood after administration
Measured: 30 days post infusion
AUC(0-30d)
the area under the curve of 30 days of anti-human MESO T cells in the peripheral blood after administration
Measured: 30 days post infusion
Duration of Mesothelin-positive T cells in circulation
Duration of Mesothelin-positive T cells in circulation
Measured: 90 days post infusion
ORR
Overall response rate after administration
Measured: 3 months post infusion
PFS
Progress Free Survival after administration
Measured: 1 year post infusion
EORTC Quality-of-Life Questionnaire Core 15 Palliative Care (QLQ-C15-PAL) of patients after administration
This QLQ-C15-PAL score consists of 15 questions; two multi-item functional scales (physical and emotional functioning), two multi-item symptom scales (fatigue and pain) together with five single-item symptom scales (nausea/vomiting, dyspnea, insomnia, appetite loss, constipation) and one final question referring to overall QOL. The physical functioning scale is based on three questions regarding walking, activities of daily living and time spent in bed or in a chair. The emotional functioning scale is based on two questions that ask about feeling tense or depressed. Patients rated each question on a Likert scale from 1 (not at all) to 4 (very much), with the exception of overall QOL, which was rated from 1 (very poor) to 7 (excellent)
Measured: 1 year post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start16 Aug 2019
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (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.
- 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hrain Biotechnology Co., Ltd.
- Responsible party
- Principal investigator, Zhao Hui, Shanghai 6th People's Hospital
- Investigators
- Hui Zhao, doctor, Principal investigator, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814447
- Sponsor's protocol ID
- MESO-CART
- Status last verified
- Aug 2021
- First submitted
- 18 Jan 2019
- Last updated
- 10 Aug 2021
- 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 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Research of Fourth Generation CART-cell Therapy in Refractory-Relapsed Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03814447
- Acronym / sponsor ID
- MESO-CART
- Conditions
- Ovarian Cancer
- Keywords
- MESO, CAR-T, Ovarian cancer, Refractory-Relapsed
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Collaborators
- Hrain Biotechnology Co., Ltd.
- Study start
- 16 Aug 2019 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 24 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 safety and feasibility of anti- Mesothelin Chimeric Antigen Receptor T-Cell (MESO CAR-T cells) therapy for Refractory-Relapsed Ovarian Cancer
Detailed description
Primary Objectives:
- To determine the safety and feasibility of anti- MESO CAR-T cells therapy for Refractory-Relapsed 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
- To assess the quality of life in patients with ovarian cancer after treatment with 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 | Drug: anti- MESO CAR-T cells, Drug: Fludarabine, Drug: CyclophosphamideThe 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histopathologically confirmed ovarian cancer;
- 18-75 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);
Key exclusion criteria (9 listed)
- 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;
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 cellsAutologous genetically modified anti- MESO CAR transduced T cells | Drug | anti- MESO CAR-T cells |
| FludarabineAlso: FADose: 30mg/m2/d | Drug | anti- MESO CAR-T cells |
| CyclophosphamideAlso: CTXDose: 300mg/m2/d | Drug | anti- MESO CAR-T cells |
Primary outcome
Adverse events (AEs) and Serious adverse event (SAEs)
Time frame: 1 year post infusion
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.03
7 secondary outcomes
Cmax
Time frame: 30 days post infusion
Tmax
Time frame: 30 days post infusion
AUC(0-30d)
Time frame: 30 days post infusion
Duration of Mesothelin-positive T cells in circulation
Time frame: 90 days post infusion
ORR
Time frame: 3 months post infusion
PFS
Time frame: 1 year post infusion
EORTC Quality-of-Life Questionnaire Core 15 Palliative Care (QLQ-C15-PAL) of patients after administration
Time frame: 1 year 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 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Hui Zhao, doctor principal investigator
Shanghai 6th People's Hospital
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 Shanghai 6th People's Hospital 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 16 inclusion and 9 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 Aug 2021. 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 Hui Zhao, doctor (021-64369181, ivy25502@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) and Serious adverse event (SAEs) (time frame: 1 year 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 Aug 2021.