MT027 treatment for patients with pleural malignant tumors

A Phase 1 Single Arm, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MT027 in Patients with Pleural Malignant Tumors

This study is testing a new treatment called MT027 for patients with pleural malignant tumors to see if it's safe and how well it works after they have already received standard treatment.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Suzhou Maximum Bio-tech Co., Ltd. (industry)
• Drugs / interventions: CAR-T
• Locations: 1 site (Beijing)
• Trial ID: NCT06726564 on ClinicalTrials.gov

What this trial studies

This phase I open-label, single-arm study evaluates the safety, tolerability, and pharmacokinetics of MT027, administered via intrapleural injection, in patients with pleural malignant tumors who have previously undergone standard treatment. Participants will receive the treatment in a dose-escalation format, with close monitoring for adverse effects and disease progression. The study aims to determine the recommended phase 2 dose (RP2D) while ensuring patient safety through rigorous follow-up assessments.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with advanced malignant solid tumors and confirmed B7-H3 overexpression.

Not a fit: Patients with non-malignant pleural conditions or those without B7-H3 overexpression may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced pleural malignant tumors.

How similar studies have performed: While this approach is novel in its specific application, similar studies targeting tumor antigens have shown promise in other contexts.

Eligibility criteria

Inclusion Criteria:

1. voluntarily participate in the study and sign informed consent;
2. age over 18 years old (including the cut-off value), regardless of gender;
3. advanced malignant solid tumor pathologically and/or histologically diagnosed with malignant pleural effusion requiring drainage confirmed by histopathology or cytopathology (metastatic or primary);
4. the original pleural cavity malignant tumor after standard treatment failure, or top treatment;
5. signed informed consent not line within a month before the chest cavity medicine injection, but does not exclude the diagnostic puncture;
6. 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;
7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-2;
8. within 7 days before treatment laboratory meet the following criteria:

Routine blood (14 days) :

1. Absolute neutrophil count (ANC) ≥1.5×109 /L;
2. platelet count (PLT) or 80 x 109 / L;
3. hemoglobin (HGB) or 80 g/L (allowing blood transfusion and use erythropoiesis agent). The presence of active bleeding or other ongoing conditions that result in increased red-cell destruction or impaired production may require repeated transfusions or red-cell therapy, and patients had to discuss their eligibility with the sponsor on an individual basis before enrollment.) ;

Liver:

1. total bilirubin (TIBC) or less 2 times the upper limit of the normal range (ULN);
2. no liver metastasis, AST and ALT 3 x ULN or less; ALT and AST≤5 times ULN in the presence of liver metastasis;

Kidney:

1. Serum creatinine (Cr) ≤ 2 times ULN; Or creatinine clearance (CrCL) ≥ 50 mL/min (estimated by Cockcroft-Gault formula);

   Blood coagulation function:
2. international standardization ratio (INR) or prothrombin time (PT) 1.3 x ULN or less;
3. Partial activated thromboplastin time (APTT) ≤ 1.5 times ULN; 9) toxicity from previous systemic therapy returned to grade 1 or less or to baseline before the first dose (except alopecia); 10) Fertile men and women of childbearing age must agree to use reliable contraception from the time they provide informed consent until 180 days after the last dose of MT027 cell injection; Women of childbearing age included those who were premenopausal and those within 2 years of menopause.

Exclusion Criteria:

1. known allergy to the study drug or its excipients;
2. patients with pleural puncture contraindications or won't benefit from intrathoracic medication;
3. 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);
4. in the first test within 2 weeks before treatment received radiotherapy.
5. major surgery is performed within 4 weeks before the first trial treatment and the patient has not fully recovered;
6. are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 1 week before the first trial treatment.
7. participated in other drug clinical trials within 4 weeks before screening;
8. always had targeted B7 - H3 CAR - T cells treatment;
9. patients with active systemic or pulmonary infection, coagulopathy and other major diseases;
10. with severe heart, lung, liver and renal insufficiency; Cardiac function: grade 3 or above according to the New York Heart Association (NYHA) criteria; Liver function: Child - Puge classification standard for grade C or above; Renal function: chronic kidney disease (CKD) stage 4 or above; Renal insufficiency stage Ⅲ or above; Pulmonary function: severe symptoms of respiratory failure involving other organs;
11. patients with severe autoimmune diseases;
12. recipients of previous allogeneic tissue/solid organ transplantation;
13. who received a live vaccine within 2 weeks before the first cell therapy or were scheduled to receive a live vaccine during the study;
14. active HBV infection; Or hepatitis C virus infection (defined as positive for HCV antibody, allowed if HCV-RNA was below the lower limit of detection); Or human immunodeficiency virus infection (defined as HIV antibody positive); Or positive treponema pallidum antibody;
15. subjects had severe neurocognitive impairment as judged by the investigator;
16. pregnant or lactating women;
17. There were any clinical or laboratory abnormalities or other reasons considered by the investigator to preclude participation in the study.

Where this trial is running

Beijing

• Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: shuhang wang, Doctoral

Conditions: Advanced Malignant Solid Tumor, Malignant Pleural Effusion, Pleura Carcinoma, Pleural Mesothelioma, Pleural Malignant Mesothelioma, Pleural Metastases, advanced malignant solid tumors, metastatic or primary malignant tumors in the pleural cavity