Actively Recruiting
SDTM001 Injection as Adjuvant Therapy for NSCLC Patients After Radical Surgical Resection
Led by Cytocraft Biopharmaceutical Co., Ltd. · Updated on 2025-07-31
22
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
SDTM001 Injection as Adjuvant Therapy for NSCLC Patients After Radical Surgical Resection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be aged 18 to 70 years old.
- Diagnosed with primary NSCLC, stage IIA to IIIB, after radical surgical removal of tumor (R0 resection).
- No recurrence of disease after surgery, with apheresis planned within one year post-operation.
- Negative for driver gene mutations (e.g., EGFR, ALK) and negative PD-L1 expression in tumor tissue.
- Completed 1 to 4 cycles of platinum-based chemotherapy before screening.
- ECOG performance status score of 0 or 1, with expected survival time of at least 12 months.
- Normal major organ function based on specific blood and laboratory test values.
- Sufficient venous access for apheresis.
- Agree to use reliable contraception during the trial and for one year after last infusion; females must have negative pregnancy test within 7 days before enrollment.
- Male participants cannot donate sperm from first infusion until one year after last infusion.
You will not qualify if you...
- Participation in other clinical trials of investigational treatments within 4 weeks prior to screening.
- Received cancer treatments (chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy) within 4 weeks prior to screening.
- Received gene-modified anti-tumor immune cell therapy within one year or non-gene-modified immune therapy within half a year prior to screening.
- Impaired cardiac function or significant cardiovascular disease including recent heart attack, severe heart failure, uncontrolled arrhythmia or hypertension, prolonged QTc interval, or history of major cardiovascular surgery.
- History of drug addiction, alcoholism above defined limits, or substance abuse.
- Active systemic infections requiring treatment, including HIV, syphilis, or active hepatitis A/B/C.
- Severe autoimmune diseases or immunodeficiency requiring long-term immunosuppressants or with severe immune-mediated diseases.
- Use of systemic immunosuppressants or immunomodulators within 28 days prior to screening or during the trial.
- History of organ transplantation, allogeneic stem cell transplantation, or renal replacement therapy.
- Receipt of live vaccines within 28 days prior to screening or planned during the study.
- Major surgery within 4 weeks prior to screening.
- Known allergy to SDT-M001 injection or related ingredients.
- History or current other malignant tumors except certain cured or non-recurrent cancers.
- Mental illness or severe mental disorders affecting consent or questionnaire completion.
- Breastfeeding women.
- Investigator judgment of inability to complete trial visits, poor compliance, or unsuitability for inclusion.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610000
Actively Recruiting
Research Team
L
Lina Sun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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