Peritoneal MesotheliomaPhase 1NCT03608618
Intraperitoneal MCY-M11 (Mesothelin-targeting CAR) for Treatment of Advanced Ovarian Cancer and Peritoneal Mesothelioma
A Phase 1 study testing MCY-M11 and Cyclophosphamide in people with Peritoneal Mesothelioma and Fallopian Tube Adenocarcinoma, run by MaxCyte, Inc. at 4 sites in United States.
Trial summary
This is a phase 1 dose escalation study to characterize the feasibility, safety and tolerability of MCY-M11 when administered as an intraperitoneal (IP) infusion for 3 weekly doses for women with platinum resistant high grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube, and subjects with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Mesothelioma, Fallopian Tube Adenocarcinoma, Adenocarcinoma of the Ovary
- What is being tested?
- MCY-M11 and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 Aug 2018to 24 Aug 2021
- Phase
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able to undergo peripheral blood leukapheresis; have successful placement of an intraperitoneal catheter
- Be diagnosed with one of the following: metastatic or unresectable high grade serous adenocarcinoma involving the ovary, primary peritoneum, or fallopian tube with peritoneal involvement, not including mixed histologies, OR unresectable epithelioid or biphasic peritoneal mesothelioma
- Be at least 4 weeks from previous anti-cancer therapy
- Have a life expectancy of greater than 3 months.
Who cannot join
- Females who are pregnant, trying to become pregnant, or breastfeeding
- Diagnosis of HIV or chronic active Hepatitis B or C
- Symptomatic or uncontrolled brain metastases requiring current treatment
- Impaired cardiac function or clinically significant cardiac disease
- Lack of recovery of prior mild adverse events due to earlier therapies
- Active infection
Show all 10Show fewer
- Another previous or current malignancy within the last 3 years, with exceptions
- Concomitant chronic use of steroids or NSAIDs
- Concomitant use of complementary or alternative medication or therapy
- Autoimmune disease or inflammatory disease within previous 5 years
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Hackensack University Medical Center
Hackensack, New Jersey, 07601
National Cancer Institute, National Institutes of Health
Rockville, Maryland, 20892
Washington University at St. Louis
St Louis, Missouri, 63110
About this study
Official title: A Phase 1 Study of Intraperitoneal MCY-M11 Therapy for Women With Platinum Resistant High Grade Serous Adenocarcinoma of the Ovary, Primary Peritoneum, or Fallopian Tube, or Subjects With Peritoneal Mesothelioma With Recurrence After Prior Chemotherapy
This is a phase 1 dose escalation study to characterize the feasibility, safety and tolerability of MCY-M11 when administered as an intraperitoneal (IP) infusion for 3 weekly doses for women with platinum resistant high grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube, and subjects with peritoneal mesothelioma with recurrence after prior chemotherapy. The study will also assess multiple cycles of treatment and adding preconditioning with cyclophosphamide.
- Conditions
- Peritoneal Mesothelioma, Fallopian Tube Adenocarcinoma, Adenocarcinoma of the Ovary, Primary Peritoneal Carcinoma
- Being tested
- MCY-M11, Cyclophosphamide
- Keywords
- platinum resistant, high grade serous adenocarcinoma, recurrence after chemotherapy, intraperitoneal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCY-M11Biological
Intraperitoneal administration
CyclophosphamideDrug
Intravenous administration for preconditioning
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 3-6 subjects will receive a starting dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks Receives: Biological: MCY-M11; Drug: Cyclophosphamide |
| Cohort 2 and 2i | Experimental | 3-6 subjects will receive a higher dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks (cohort 2); 3-6 subjects will receive MCY-M11 and cyclophosphamide preconditioning (cohort 2i) Receives: Biological: MCY-M11; Drug: Cyclophosphamide |
| Cohort 3 and 3i | Experimental | 3-6 subjects will receive a higher dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks (cohort 3); 3-6 subjects will receive MCY-M11 and cyclophosphamide preconditioning (cohort 3i) Receives: Biological: MCY-M11; Drug: Cyclophosphamide |
| Cohort 4 and 4i | Experimental | 3-6 subjects will receive a higher dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks (cohort 4); 3-6 subjects will receive MCY-M11 and cyclophosphamide preconditioning (cohort 4i) Receives: Biological: MCY-M11; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events as assessed by CTCAE v.5.0
number and severity of adverse events according to NCI CTCAE v.5.0
Measured: 6 weeks
Secondary outcomes (2)
Response Evaluation Criteria in Solid Tumors (RECIST)
tumor response scored by RECIST criteria
Measured: from first MCY-M11 dosing to first documented progression, assessed up to 24 months
Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
tumor response scored by irRECIST criteria
Measured: from first MCY-M11 dosing to first documented progression, assessed up tp 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start27 Aug 2018
- Primary completion11 Feb 2021
- Study completion24 Aug 2021
Why it stopped: Sponsor shift in focus
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal MesotheliomaStudies 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- MaxCyte, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CTI Clinical Trial and Consulting Services
- Responsible party
- Sponsor
- Investigators
- Claudio Dansky Ullmann, MD, Study director, MaxCyte, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608618
- Sponsor's protocol ID
- CP-M11-101
- Status last verified
- Aug 2021
- First submitted
- 16 Jul 2018
- Last updated
- 5 Sep 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Intraperitoneal MCY-M11 Therapy for Women With Platinum Resistant High Grade Serous Adenocarcinoma of the Ovary, Primary Peritoneum, or Fallopian Tube, or Subjects With Peritoneal Mesothelioma With Recurrence After Prior Chemotherapy
- ClinicalTrials.gov ID
- NCT03608618
- Acronym / sponsor ID
- CP-M11-101
- Conditions
- Peritoneal Mesothelioma, Fallopian Tube Adenocarcinoma, Adenocarcinoma of the Ovary, Primary Peritoneal Carcinoma
- Keywords
- platinum resistant, high grade serous adenocarcinoma, recurrence after chemotherapy, intraperitoneal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor shift in focus
- Enrolment
- 14 participants (actual)
- Lead sponsor
- MaxCyte, Inc.Industry (pharma, biotech, devices)
- Collaborators
- CTI Clinical Trial and Consulting Services
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 11 Feb 2021 (actual)
- Study completion
- 24 Aug 2021 (actual)
- First posted
- 1 Aug 2018 (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.
This is a phase 1 dose escalation study to characterize the feasibility, safety and tolerability of MCY-M11 when administered as an intraperitoneal (IP) infusion for 3 weekly doses for women with platinum resistant high grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube, and subjects with peritoneal mesothelioma with recurrence after prior chemotherapy. The study will also assess multiple cycles of treatment and adding preconditioning with cyclophosphamide.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: MCY-M11, Drug: Cyclophosphamide3-6 subjects will receive a starting dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks |
| Cohort 2 and 2i | Experimental | Biological: MCY-M11, Drug: Cyclophosphamide3-6 subjects will receive a higher dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks (cohort 2); 3-6 subjects will receive MCY-M11 and cyclophosphamide preconditioning (cohort 2i) |
| Cohort 3 and 3i | Experimental | Biological: MCY-M11, Drug: Cyclophosphamide3-6 subjects will receive a higher dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks (cohort 3); 3-6 subjects will receive MCY-M11 and cyclophosphamide preconditioning (cohort 3i) |
| Cohort 4 and 4i | Experimental | Biological: MCY-M11, Drug: Cyclophosphamide3-6 subjects will receive a higher dose of MCY-M11 via intraperitoneal infusion once weekly for 3 weeks (cohort 4); 3-6 subjects will receive MCY-M11 and cyclophosphamide preconditioning (cohort 4i) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be able to undergo peripheral blood leukapheresis; have successful placement of an intraperitoneal catheter
- Be diagnosed with one of the following: metastatic or unresectable high grade serous adenocarcinoma involving the ovary, primary peritoneum, or fallopian tube with peritoneal involvement, not including mixed histologies, OR unresectable epithelioid or biphasic peritoneal mesothelioma
- Be at least 4 weeks from previous anti-cancer therapy
- Have a life expectancy of greater than 3 months.
Key exclusion criteria (10 listed)
- Females who are pregnant, trying to become pregnant, or breastfeeding
- Diagnosis of HIV or chronic active Hepatitis B or C
- Symptomatic or uncontrolled brain metastases requiring current treatment
- Impaired cardiac function or clinically significant cardiac disease
- Lack of recovery of prior mild adverse events due to earlier therapies
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 |
|---|---|---|
| MCY-M11Intraperitoneal administration | Biological | Cohort 1, Cohort 2 and 2i, Cohort 3 and 3i, Cohort 4 and 4i |
| CyclophosphamideIntravenous administration for preconditioning | Drug | Cohort 1, Cohort 2 and 2i, Cohort 3 and 3i, Cohort 4 and 4i |
Primary outcome
Incidence and severity of adverse events as assessed by CTCAE v.5.0
Time frame: 6 weeks
number and severity of adverse events according to NCI CTCAE v.5.0
2 secondary outcomes
Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: from first MCY-M11 dosing to first documented progression, assessed up to 24 months
Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
Time frame: from first MCY-M11 dosing to first documented progression, assessed up tp 24 months
Results and safety
The study was stopped early (reason given: Sponsor shift in focus). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
Claudio Dansky Ullmann, MD study director
MaxCyte, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MCY-M11 and Cyclophosphamide in people with Peritoneal Mesothelioma and Fallopian Tube Adenocarcinoma, run by MaxCyte, Inc. at 4 sites in United States.
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 4 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: stopped early, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor shift in focus). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events as assessed by CTCAE v.5.0 (time frame: 6 weeks). 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 5 Sep 2021.