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The goal of this clinical trial is to evaluate the safety profile and tolerability of SDT-M001 injection in NSCLC patients with driver-gene-negative and negative PD-L1 expression after radical surgical resection; to determine the recommended Phase II dose (RP2D).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SDT-M001 injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SDT-M001 injection | Biological | Cascade primed immune cells(CAPRI); SDT-M001 injection is administered at three dose levels:1.5e9 cells, 3e9 cells,6e9 cells. The cells will be reinfused in 3 divided doses, administered every other day, and the total process will take 5 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety profile of SDT-M001 injection | Safety assessments are conducted using the NCI-CTCAE version 5.0 standards. Adverse events (AE) of all subjects entering this trial, including serious adverse events (SAE); laboratory examination indicators. | From enrollment up to 24 Months After the end of the last infusion |
| Tolerability of SDT-M001 injection | The number and severity of dose-limiting toxicity (DLT) events. Calculate the incidence of DLT. | From enrollment to 28 days after the end of the last infusion |
| RP2D | If the maximum tolerated dose (MTD) has been proven to be feasible for long-term clinical administration in a reasonable number of subjects, then this dose is usually RP2D. | Until the end of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic effect evaluation | Efficacy evaluation will be conducted according to the RECIST 1.1 criteria. | From enrollment up to 24 Months After the end of the last infusion. |
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Inclusion Criteria:
Exclusion Criteria:
(1) Acute myocardial infarction or unstable angina pectoris ≤6 months prior to screening; (2) New York Heart Association classified III/IV congestive cardiac failure; (3) Uncorrected severe arrhythmia and hypertension ≥150/100 mmHg; (4) Prolonged QTc interval (> 450ms in males , > 470ms in females); (5) History of other significant cardiovascular diseases (e.g., valve replacement surgery, coronary artery bypass grafting).
5. Participants with a history of drug addiction, alcoholism (defined as average daily pure alcohol intake ≥61g for men or ≥41g for women), or substance abuse.
6. Participants with systemic active infections requiring treatment, including but not limited to HIV-positive, syphilis positive, or clinically active hepatitis A/B/C infection.
7. Participants with severe autoimmune diseases or immunodeficiency, such as those requiring long-term (≥2 months) systemic immunosuppressant (e.g., steroid) for severe autoimmune diseases, or those with severe immune-mediated symptomatic diseases (e.g., ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE), autoimmune vasculitis(e.g., Wegener granulomatosis)).
8. Participants who require systemic immunosuppressants (e.g., cortisol, hydroxyurea) within 28 days prior to screening or during the trial, or other immunomodulators (e.g., interferon-alpha/gamma, GM-CSF, mTOR inhibitors, cyclosporine, thymosin).
9. Participants with a history of organ transplantation, allogeneic stem cell transplantation or renal replacement therapy; 10. Participants who have received live vaccines within 28 days prior to screening or plan to receive live vaccines during the study period.
11. Participants who have undergone major operations within 4 weeks prior to screening.
12. Participants with known allergic reactions to SDT-M001 injection, its active ingredients, excipients, or a history of allergy to cell products 13. Participants with a history of or current other malignant tumors, except:
14. Participants with any mental illness or severe mental disorder (e.g., dementia, altered mental status) that may affect informed consent or comprehension of questionnaires.
15. Breastfeeding women are excluded. 16. Participants who are deemed by the investigator to be unable to complete trial visits, evaluations, or follow-ups, have poor compliance, or are otherwise unsuitable for inclusion.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lina Sun | Contact | 028-87586128 | sunlina@cytocraft.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610000 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |