A Study of MT027 in Patients with Pleural Malignant Tumors

NCT06726564 | Recruiting Phase 1 DMC

• 1 other identifier: MT027-MPE-001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Malignant Solid Tumor; Malignant Pleural Effusion; Pleura Carcinoma; Pleural Mesothelioma; Pleural Malignant Mesothelioma; Pleural Metastases

Keywords

advanced malignant solid tumors; metastatic or primary malignant tumors in the pleural cavity; malignant pleural effusion

Outcome Measures

Primary Outcomes (5)

• adverse events (AE) and serious adverse events (SAE)

  through study completion, an average of 1 year

• Dose Limiting Toxicity (DLT)

  28 days

• GvHD

  through study completion, an average of 1 year

• CRS

  through study completion, an average of 1 year

• Immune effector cell-associated neurotoxicity syndrome (ICANs)

  through study completion, an average of 1 year

Study Arms (1)

MT027

EXPERIMENTAL

Drug: MT027 cells suspension

Interventions

MT027 cells suspension DRUG

MT027: CRISPR/Cas9 edited B7H3-specific allogeneic CAR-T cells

MT027

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-2;
• within 7 days before treatment laboratory meet the following criteria:
• Routine blood (14 days) :
• Absolute neutrophil count (ANC) ≥1.5×109 /L;
• platelet count (PLT) or 80 x 109 / L;
• 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:
• total bilirubin (TIBC) or less 2 times the upper limit of the normal range (ULN);
• no liver metastasis, AST and ALT 3 x ULN or less; ALT and AST≤5 times ULN in the presence of liver metastasis;

You may not qualify if:

• 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;
• patients with active systemic or pulmonary infection, coagulopathy and other major diseases;
• 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;
• patients with severe autoimmune diseases;
• recipients of previous allogeneic tissue/solid organ transplantation;
• who received a live vaccine within 2 weeks before the first cell therapy or were scheduled to receive a live vaccine during the study;
• 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;
• subjects had severe neurocognitive impairment as judged by the investigator;

Sponsors & Collaborators

• Suzhou Maximum Bio-tech Co., Ltd.: lead
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Pleural Effusion, Malignant; Mesothelioma, Malignant; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases; Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Lung Neoplasms; Lung Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

shuhang wang, Doctoral

CONTACT

010-87788713; snowflake201@gmail.com

ning jiang, Doctoral

CONTACT

010-87788165; jiangn12@foxmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: December 10, 2024
• Study Start: May 15, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): February 1, 2029
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

CN (1)