A Study of MT027 in Patients with Pleural Malignant Tumors (NCT06726564) | Clinical Trial Compass
RecruitingPhase 1
A Study of MT027 in Patients with Pleural Malignant Tumors
China18 participantsStarted 2024-05-15
Plain-language summary
This is a phase I open label, single-arm, dose-escalation study to evaluate the feasibility, safety, tolerability, PK/PD, and to determine RP2D of MT027 via an locoregional delivery in subjects with pleural malignant tumors, who have previously received standard of care therapy..
Subjects meeting the study entry criteria including having tumor antigen B7H3 overexpression via immunohistochemistry (IHC ) will be enrolled and assigned to cohorts sequentially to receive study treatments, assessments, as well as post-treatment safety follow-ups in the study.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. voluntarily participate in the study and sign informed consent;
. age over 18 years old (including the cut-off value), regardless of gender;
. advanced malignant solid tumor pathologically and/or histologically diagnosed with malignant pleural effusion requiring drainage confirmed by histopathology or cytopathology (metastatic or primary);
. the original pleural cavity malignant tumor after standard treatment failure, or top treatment;
. signed informed consent not line within a month before the chest cavity medicine injection, but does not exclude the diagnostic puncture;
. The subjects voluntarily provided sufficient tumor cells in the pathological section of the primary lesion and/or pleural effusion for B7-H3 expression detection, and the tumor cells in the pathological section of the primary lesion or malignant pleural effusion were positive for B7-H3 expression;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
adverse events (AE) and serious adverse events (SAE)
Timeframe: through study completion, an average of 1 year
2
Dose Limiting Toxicity (DLT)
Timeframe: 28 days
3
GvHD
Timeframe: through study completion, an average of 1 year
4
CRS
Timeframe: through study completion, an average of 1 year
. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-2;
. within 7 days before treatment laboratory meet the following criteria:
Exclusion criteria
. known allergy to the study drug or its excipients;
. patients with pleural puncture contraindications or won't benefit from intrathoracic medication;
. any antineoplastic drugs other than systemic antineoplastic therapy that the subject has been taking stably and any treatment that may have an effect on the control of pleural effusion (other than diagnostic puncture or thoracentesis for investigational treatment);
. in the first test within 2 weeks before treatment received radiotherapy.
. major surgery is performed within 4 weeks before the first trial treatment and the patient has not fully recovered;
. are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 1 week before the first trial treatment.
. participated in other drug clinical trials within 4 weeks before screening;
. always had targeted B7 - H3 CAR - T cells treatment;