Actively Recruiting
A Phase 1 Single Arm, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MT027 in Patients with Pleural Malignant Tumors
Led by Suzhou Maximum Bio-tech Co., Ltd. ยท Updated on 2024-12-10
18
Participants Needed
1
Research Sites
143 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
Researchers are evaluating MT027, a CRISPR/Cas9 edited B7H3-specific allogeneic CAR-T cell therapy, in adults with pleural malignant tumors who have previously received standard care. This phase I, open-label, single-arm study aims to assess the feasibility, safety, tolerability, pharmacokinetics, pharmacodynamics, and to determine the recommended dose of MT027 delivered directly into the pleural cavity. Participants must have tumors that overexpress the B7H3 antigen. MT027 is administered by injection into the pleural cavity on day 1 of a 28-day cycle, followed by a 28-day monitoring period for dose-limiting toxicities. If no significant toxicity or disease progression occurs, treatment continues every three weeks with injections on day 1 or 2 of each 21-day cycle. After the first dose, participants stay in the hospital for at least seven days for close monitoring and safety assessments. Dose adjustments or temporary treatment interruptions may be made based on tolerance and adverse events. Participants will receive treatment until intolerable side effects, disease progression, withdrawal, or death. Safety is assessed through adverse event monitoring, including serious events, graft-versus-host disease, cytokine release syndrome, and neurotoxicity over about one year. Follow-up continues for up to 15 years with periodic telephone check-ins. The study includes laboratory tests, clinical evaluations, and tumor antigen testing to monitor treatment effects and participant health throughout the trial.
CONDITIONS
Brief 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 involving pleural malignant effusion confirmed by pathology or cytology
- Tumor has failed standard treatments or is at top treatment stage
- Provide tumor tissue or pleural effusion samples showing positive B7H3 antigen expression
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2
- Laboratory tests within 7 days before treatment meeting specified blood, liver, kidney, and coagulation criteria
- Toxicity from previous therapies returned to grade 1 or baseline (except hair loss)
- Fertile participants agree to use reliable contraception until 180 days after last MT027 dose
You will not qualify if you...
- Allergy to MT027 or its components
- Contraindications to pleural puncture or unlikely to benefit from intrathoracic medication
- Use of other antineoplastic drugs affecting pleural effusion control
- Radiotherapy within 2 weeks before treatment
- Major surgery within 4 weeks before treatment without full recovery
- Systemic steroid or immunosuppressive therapy within 1 week before treatment
- Participation in other drug trials within 4 weeks before screening
- Previous targeted B7H3 CAR-T cell therapy
- Active infections, coagulopathy, or major diseases
- Severe heart, lung, liver, or kidney failure
- Severe autoimmune diseases
- Previous allogeneic tissue or organ transplant
- Live vaccine within 2 weeks before treatment or planned during study
- Active hepatitis B, hepatitis C (with detectable virus), HIV, or syphilis infection
- Severe neurocognitive impairment
- Pregnant or breastfeeding women
- Other clinical or lab abnormalities deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycle for first cycle followed by 21-day cycles thereafter until intolerable toxicity or disease progression
Participants receive MT027 via intrapleural injection on Day 1 of the first 28-day cycle, followed by a 28-day dose limiting toxicity observation period. If no unacceptable toxicities or disease progression occur, treatment continues every three weeks with additional injections on the first or second day of each 21-day cycle. Participants are observed in the hospital for at least 7 days after the first injection and have safety assessments on Day 14 and Day 28 before the second injection. Treatment continues until intolerable toxicity, disease progression, withdrawal, or death.
Hospital observation for at least 7 days after first injection; visits on Day 14 and Day 28 after first injection; subsequent injections every 3 weeks
Duration - Up to 15 years after last dose
After completing or withdrawing from treatment, participants have an end of treatment/early termination visit within 30 days from the last study drug infusion. Telephone follow-ups occur every 12 weeks for up to 15 years as clinically necessary to monitor safety.
1 visit within 30 days post treatment and telephone follow-ups every 12 weeks
Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
Research Team
S
shuhang wang, Doctoral
N
ning jiang, Doctoral
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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