Actively Recruiting
A Study of MT027 in Patients with Pleural Malignant Tumors
Led by Suzhou Maximum Bio-tech Co., Ltd. · Updated on 2024-12-10
18
Participants Needed
1
Research Sites
246 weeks
Total Duration
On this page
Sponsors
S
Suzhou Maximum Bio-tech Co., Ltd.
Lead Sponsor
C
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of MT027 in Patients with Pleural Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Age 18 years or older, any gender
- Diagnosed with advanced malignant solid tumor and malignant pleural effusion confirmed by pathology
- Tumor in pleural cavity after standard treatment failure or top treatment
- Provided tumor cells showing positive B7H3 expression for testing
- ECOG performance status score of 0 to 2
- Laboratory results within 7 days before treatment meeting specified blood, liver, kidney, and coagulation criteria
- Toxicity from previous therapy resolved to grade 1 or baseline before first dose
- Fertile men and women of childbearing age agree to use reliable contraception from consent until 180 days after last MT027 dose
You will not qualify if you...
- Known allergy to MT027 or its components
- Contraindications for pleural puncture or unlikely benefit from intrathoracic treatment
- Use of other antineoplastic drugs affecting pleural effusion control (except diagnostic puncture/thoracentesis)
- Radiotherapy received within 2 weeks before treatment
- Major surgery within 4 weeks before first treatment and not fully recovered
- Receiving systemic steroids or immunosuppressive therapy within 1 week before treatment
- Participation in other drug trials within 4 weeks before screening
- Prior treatment with targeted B7H3 CAR-T cells
- Active systemic or pulmonary infections, coagulopathy, or major diseases
- Severe heart, lung, liver, or kidney failure meeting specified criteria
- Severe autoimmune diseases
- Previous allogeneic tissue or organ transplantation
- Live vaccine received within 2 weeks before or planned during study
- Active HBV, hepatitis C, HIV infection, or positive syphilis antibody
- Severe neurocognitive impairment
- Pregnant or breastfeeding women
- Any clinical or laboratory reason deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
Research Team
S
shuhang wang, Doctoral
CONTACT
N
ning jiang, Doctoral
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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