Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04684459
Other study ID # MCART-002
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date March 12, 2021
Est. completion date December 30, 2025

Study information

Verified date November 2023
Source Sichuan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Serosal cavity metastasis of malignant tumor is one of the late complications, which seriously affects the quality of life and survival time of patients. HER-2 is frequently expressed in breast cancer, ovarian cancer, lung cancer, gastric cancer and other malignant tumors. The HER-2/PD-L1 dual-targeting CAR-T will be investigated in patients with HER2 positive solid tumor serosal cavity metastases.


Recruitment information / eligibility

Status Recruiting
Enrollment 18
Est. completion date December 30, 2025
Est. primary completion date December 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 1. Male or female, Age 18-65 years old; 2. Estimated life expectancy = 3 months (according to investigator's judgement); 3. The Eastern Cooperative Oncology Group (ECOG) performance status score is 0-2; 4. Patients diagnosed as ovarian cancer, non-small cell lung cancer, breast cancer, gastric cancer, etc., accompanied by serous cavity metastasis, have received systemic standard treatment, and have clinical symptoms of serous cavity metastasis; 5. Expressing HER2 >20% of primary tumors or metastatic cells in the serous cavity by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH); 6. Absolute neutrophil count = 1×10^9/L, platelet count = 75×10^9/L, absolute lymphocyte count =1×10^8/L, hemoglobin = 9.0 g/dl; 7. Creatinine clearance rate =60ml/min, Serum ALT/AST=2.5 times of the normal level, and total bilirubin=1.5 times of the normal level; 8. Cardiac ejection fraction =50%, no pericardial effusion; 9. No other serious diseases (autoimmune diseases or any immune deficiency disease or other disease in need of immunosuppressive therapy); 10. Patients must stop chemotherapy and targeted therapy for at least 3 weeks before starting treatment; 11. Patients must take reliable contraceptive measures before entering the trial, during the research process until 1 year after CAR-T infusion; reliable contraceptive measures will be determined by the main investigator or designated personnel; 12. Voluntarily participate in the research, understand and sign the informed consent; 13. The side effect of the last anti-tumor treatment was reduced to =1 grade, except for hair loss. Exclusion Criteria: 1. Allergic to cytokines; 2. Uncontrolled activity infection; 3. Acute or chronic (graft-versus-host disease) GVHD; 4. Accompanied by other uncontrolled malignant tumors; 5. Patient with hepatitis B or C active period, HIV infection = the upper limit of the normal level; 6. Suffer from serious diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, etc.; 7. Patients with grade 2-3 hypertension or poorly controlled; 8. History of mental illness that is difficult to control; 9. Patients have used immunosuppressive agents for a long time after organ transplantation, except for recent or current inhaled corticosteroid therapy; 10. The existing medical history or mental state history or laboratory abnormalities may increase the risk associated with participating in the study or the administration of the study drug; 11. Unstable pulmonary embolism, deep venous embolism or other major arterial/venous thromboembolic events occurred within 6 months before enrollment. If receiving anticoagulant therapy; 12. Pregnant or nursing women, or plan to become pregnant during the treatment period or within 1 year after the treatment ends; 13. Patient suffering from diseases that have signed written informed consent or comply with research procedures; or are unwilling or unable to comply with research requirements.

Study Design


Intervention

Biological:
Dual-targeting HER2 and PD-L1 CAR-T cells
serosal cavity infusion

Locations

Country Name City State
China West China Hospital, Sichuan University Chengdu Sichuan

Sponsors (1)

Lead Sponsor Collaborator
Sichuan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Treatment-Related Adverse Events AE during the first 28 days after CAR-T cell administration 12 months
Primary Dose-limiting toxicity (DLT) Baseline up to 28 days after CAR-T cells infusion 12 months
Secondary ORR(objective response rate) Include CR(complete response)and PR(partial response) Month 1,month 3, month 6
Secondary DOR (duration of response) The time from achievement of disease control 12 months
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05693727 - Cancer Ratio,Pleural Fluid Adenosine Deaminase,Lactate Dehydrogenase, interferonY, Tumor Necrosis Factor,and Interleukins{2,12,18}for Differentiation Between Malignant and Non Malignant Pleural Effusion
Recruiting NCT05910112 - Prospective Data Collection on Clinical, Radiological and Patient Reported Outcomes After Pleural Intervention
Completed NCT03270215 - The Added Value of CT Scanning in Patients With an Unilateral Pleural Effusion
Completed NCT03272997 - The Value of PET-CT in Pleural Effusions
Completed NCT00099541 - Non-small Cell Lung Cancer Registry Phase 4
Recruiting NCT04844827 - Pleural Carcinomatosis Tissue Banking
Not yet recruiting NCT06436807 - PMCF Study of the CE-marked Drainova® ArgentiC Catheter
Recruiting NCT05278975 - Study of RSO-021 in Patients With Malignant Pleural Effusion Due to Advanced/Metastatic Solid Tumors Including Mesothelioma Phase 1/Phase 2
Recruiting NCT02407912 - Cisplatin for Malignant Pleural Effusion in Patients With Non-small-cell Lung Cancer N/A
Terminated NCT00316134 - Multiple Biomarkers in Undiagnosed Pleural Effusion N/A
Not yet recruiting NCT06275178 - Medical Thoracoscopy for Diagnosing Unexplained Pleural Effusion: a National Multicenter Retrospective Study
Recruiting NCT04670562 - Longitudinal Follow up of Patients With Pleural Effusion
Not yet recruiting NCT02805062 - Manometry vs Clinical Assessment in the Detection of Trapped Lung in Patients With Suspected Pleural Malignancy N/A
Completed NCT03276715 - Prognostic Factors on Malignant Pleural Effusion
Completed NCT03394105 - Intrapleural Docetaxel Administration Using Medical Pleuroscopy in Malignant Effusion With Lung Cancer Phase 2
Recruiting NCT05461430 - Mass Response of Tumor Cells as a Biomarker for Rapid Therapy Guidance (TraveraRTGx)
Terminated NCT02702700 - Photo-induction as a Means to Improve Cisplatin Delivery to Pleural Malignancies Phase 1
Recruiting NCT02045121 - Multicentre Study Comparing Indwelling Pleural Catheter With Talc Pleurodesis for Malignant Pleural Effusion Management N/A
Completed NCT01670786 - Safety Profile of Iodopovidone as an Agent for Pleurodesis in Malignant Pleural Effusion Phase 4
Active, not recruiting NCT05077111 - A Comparative Study Between Regional Anesthesia in Thoracoscopes and the Conventional General Anesthesia Phase 4