Dual-targeting VEGFR1 and PD-L1 CAR-T for Cancers Patients With Pleural or Peritoneal Metastases
NCT ID: NCT05477927
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
58 participants
INTERVENTIONAL
2023-11-28
2024-12-31
Brief Summary
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Detailed Description
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There are two part of this study, the first is dose escalation part, 18 patients with malignant tumor (failure of standard treatment will be enrolled at least, patients with peritonea cavity metastases are planned to be enrolled in the cohort 1, and those with pleural cavity metastasis are enrolled in the cohort 2. The second is dose expansion part, the curative effect has observed in the first part, and after the DLT observation period of the related dose group was finished, the PI will decided whether to conduct the dose expansion research finally. It was planned to enroll 40 patients with serous cavity metastases , two cohorts were divided the same as mentioned above in dose escalation part.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CAR-T cell therapy
Dual-targeting VEGFR1 and PD-L1 CAR-T cells
Dual-targeting VEGFR1 and PD-L1 CAR-T cells
In the dose escalation part, the dose levels will be escalated following a traditional escalation scheme for 3+3 design.
In the dose expansion part, patients will be assigned to different groups based on pleural or peritoneal metastases condition.
Interventions
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Dual-targeting VEGFR1 and PD-L1 CAR-T cells
In the dose escalation part, the dose levels will be escalated following a traditional escalation scheme for 3+3 design.
In the dose expansion part, patients will be assigned to different groups based on pleural or peritoneal metastases condition.
Eligibility Criteria
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Inclusion Criteria
2. 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;
3. The Eastern Cooperative Oncology Group (ECOG) performance status score is 0-2;
4. Estimated life expectancy ≥ 3 months (according to investigator's judgement);
5. Absolute neutrophil count ≥ 1.5×10\^9/L, platelet count ≥ 90×10\^9/L, absolute lymphocyte count ≥1×10\^8/L, hemoglobin ≥ 9.0 g/dL;
6. Creatinine clearance rate ≥60 mL/min, Serum ALT/AST≤2.5 times of the normal level, and total bilirubin≤1.5 times of the normal level;
7. Cardiac ejection fraction ≥50%, no pericardial effusion;
8. No other serious diseases (autoimmune diseases or any immune deficiency disease or other disease in need of immunosuppressive therapy);
9. Patients must stop chemotherapy and targeted therapy for at least 3 weeks before starting treatment;
10. 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;
11. Voluntarily participate in the research, understand and sign the informed consent;
12. The side effect of the last anti-tumor treatment was reduced to ≤1 grade, except for hair loss.
Exclusion Criteria
2. Allergic to cytokines; 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. Other uncontrolled diseases in active period that hinder participation in the trial;
7. Suffer from serious diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, etc.;
8. Patients with grade 2-3 hypertension or poorly controlled;
9. History of mental illness that is difficult to control;
10. Patients have used immunosuppressive agents for a long time after organ transplantation, except for recent or current inhaled corticosteroid therapy;
11. 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 from the point view of PI;
12. Unstable pulmonary embolism, deep venous embolism or other major arterial/venous thromboembolic events occurred within 6 months before enrollment. If receiving anticoagulant therapy;
13. Pregnant or nursing women, or plan to become pregnant during the treatment period or within 1 year after the treatment ends;
14. Female subjects of childbearing age were reluctant to accept high-efficiency contraceptive measures during the treatment period or within 1 year after the treatment ends;
15. 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;
16. Patients who are inappropriate to participate in this experiment as considered by PI.
18 Years
65 Years
ALL
No
Sponsors
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Sichuan University
OTHER
Responsible Party
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Yongsheng Wang
Director of Institute of Drug Clinical Trial of West China Hospital
Principal Investigators
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YongShen Wang, Prof.
Role: PRINCIPAL_INVESTIGATOR
West China Hospital
Locations
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West China Hospital, Sichuan University
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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References
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Cheema PK, Burkes RL. Overall survival should be the primary endpoint in clinical trials for advanced non-small-cell lung cancer. Curr Oncol. 2013 Apr;20(2):e150-60. doi: 10.3747/co.20.1226.
Wagner DL, Fritsche E, Pulsipher MA, Ahmed N, Hamieh M, Hegde M, Ruella M, Savoldo B, Shah NN, Turtle CJ, Wayne AS, Abou-El-Enein M. Immunogenicity of CAR T cells in cancer therapy. Nat Rev Clin Oncol. 2021 Jun;18(6):379-393. doi: 10.1038/s41571-021-00476-2. Epub 2021 Feb 25.
Other Identifiers
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MCART-006
Identifier Type: -
Identifier Source: org_study_id