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Epithelial Ovarian CancerPhase 1NCT04562298

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LCAR-M23, a CAR-T Cell Therapy Targeting MSLN in Patients With Relapsed and Refractory Epithelial Ovarian Cancer

A Phase 1 study testing LCAR-M23 cells in people with Epithelial Ovarian Cancer, run by Shanghai East Hospital at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is a prospective, single-arm, open-label, single-dose dose finding and extension study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the LCAR-M23 CAR-T cell therapy in subjects with relapsed and refractory epithelial ovarian cancer after prior adequate standard… Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Epithelial Ovarian Cancer
What is being tested?
LCAR-M23 cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteChina
Study dates
21 Oct 2020to 7 Jun 2022
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 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subjects have been fully informed of the possible risks and benefits of participating in this study and have voluntarily signed the informed consent form (ICF)
  • Age: 18-70 years (including 18 and 70 years)
  • Female subjects with histologically or cytologically confirmed advanced epithelial ovarian cancer including fallopian tube and primary peritoneal cancers
  • Mesothelin (MSLN) positive
  • Prior adequate standard of care, treatment failure or intolerance.
  • Imaging shows an evaluable tumor lesion
  • ECOG 0-1
  • Expected survival ≥ 3 months

Who cannot join

  • Patients who have received the following anti-tumor treatments prior to apheresis:
  • Cytotoxic therapy within 14 days
  • Small molecule targeted therapy within 14 days or at least 5 half-lives, whichever is shorter
  • Therapy with monoclonal antibody within 21 days
  • Immunomodulatory therapy within 7 days
  • Radiotherapy within 14 days and endocrine therapy within 14 days (including tamoxifen, aromatase inhibitor, high-potency progesterone and gonadotropin-releasing hormone analogue, etc.)
Show all 11Show fewer
  • Previously treated with CAR-T/TCR-T cell therapy against any target or other cell therapies or therapeutic tumor vaccine
  • Previously treated with any MSLN-targeted therapy
  • Brain metastases with central nervous system symptoms
  • Pregnant or lactating women
  • Any condition in which, in the opinion of the investigator, the subject is ineligible for participation in the study

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality

Other trials in China

About this study

This study is a prospective, single-arm, open-label, single-dose dose finding and extension study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the LCAR-M23 CAR-T cell therapy in subjects with relapsed and refractory epithelial ovarian cancer after prior adequate standard of care.

Being tested
LCAR-M23 cells
Keywords
Epithelial Ovarian Cancer
Medical subject headings
Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LCAR-M23 cellsBiological

    Prior to infusion of LCAR-M23, subjects will receive a premedication regimen (intravenous infusion of cyclophosphamide 300 mg/m2 and fludarabine 30 mg/m2 once daily for 3 days; fludarabine dose reduction to 25 mg/m2 and cyclophosphamide to 250 mg/m2 are allowed if the subject' s creatinine clearance is 50-70 mL/min/1.73 m2). A single dose, single Infusion of LCAR-M23 is scheduled 5 to 7 days after the initiation of the premedication regimen.

Study groups in NCT04562298
Study groupRoleWhat they receive
LCAR-M23 Chimeric Antigen Receptor T cellExperimentalNot described
Receives: Biological: LCAR-M23 cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity (DLT) and incidence, severity, and type of treatment-emergent adverse events (TEAEs)

    Dose-limiting toxicity (DLT) refers to a drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose. An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment.

    Measured: 90 days post infusion

  2. MTD/ RP2D regimen finding

    Maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)

    Measured: 90 days post infusion

  3. Chimeric Antigen Receptor T (CAR-T) Positive Cell Concentration

    Venous blood samples will be collected for measurement of CAR-T positive cellular concentration

    Measured: 2 years post infusion

Secondary outcomes (6)

  1. Disease control rate (DCR) after administration

    Disease Control Rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease.

    Measured: 2 years post infusion

  2. Objective Response Rate (ORR) after administration

    Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment via LCAR-M23 cell infusion, and the objective tumor response rate will be calculated for patients with measurable disease as per RECIST 1.1 criteria only.

    Measured: 2 years post infusion

  3. Time to Response (TTR) after administration

    Time to Response (TTR) is defined as the time interval from the date of first infusion of LCAR-M23 cell formulation to the date of the first response evaluation of the subject who has met all criteria for PR or better.

    Measured: 2 years post infusion

  4. Duration of Response (DOR) after administration

    Duration of Response (DOR) is defined as the time from the first documentation of response (PR or better) to the first documentation of disease progression evidence (as per RECIST 1.1 criteria) of the responders (who achieve PR or better response).

    Measured: 2 years post infusion

  5. Progress Free Survival (PFS) after administration

    Progression Free Survival (PFS) is defined as the time interval from the date of first infusion of LCAR-M23 cell formulation to the first documentation of disease progression (as per RECIST 1.1 criteria) or death (due to any cause), whichever occurs first.

    Measured: 2 years post infusion

  6. Overall Survival (OS) after administration

    Overall survival (OS) is defined as the time interval from the date of first infusion of LCAR-M23 cell formulation to death of the subject.

    Measured: 2 years post infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2020
  2. Study start21 Oct 2020
  3. Primary completion7 Jun 2022
  4. Study completion7 Jun 2022

Why it stopped: Both the sponsors and collaborator are considering terminating the study.

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04562298
Sponsor's protocol ID
BM2L201906
Status last verified
Oct 2021
First submitted
19 Sep 2020
Last updated
18 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LCAR-M23 cells in people with Epithelial Ovarian Cancer, run by Shanghai East 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 8 inclusion and 11 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 18 Aug 2022. 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?

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: Both the sponsors and collaborator are considering terminating the study.). 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?

Dose-limiting toxicity (DLT) and incidence, severity, and type of treatment-emergent adverse events (TEAEs) (time frame: 90 days post infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04562298.

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 18 Aug 2022.

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