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Non-Small Cell Lung CancerPhase 1NCT07096882

SDTM001 Injection as Adjuvant Therapy for NSCLC Patients After Radical Surgical Resection

A Phase 1 study testing SDT-M001 injection in people with Non-Small Cell Lung Cancer, run by Cytocraft Biopharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
SDT-M001 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteChina
Study dates
26 Jul 2025to 26 Jun 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All participants must be informed of the trial before any examinations stipulated in this trial are initiated, voluntarily sign the written informed consent form (ICF) approved by the ethics committee, and be able to comply with the research procedures.
  • Age ranges from 18 to 70 years old (including threshold), regardless of gender.
  • For participants diagnosed with primary NSCLC according to the standards of the "Chinese Medical Association guideline for clinical diagnosis and treatment of lung cancer(2024 edition)" and the "Clinical Practice Guideline for Primary Lung Cancer(2022 Version)", and who have undergone radical surgical resection (R0) treatment, the TNM stage is classified as stage IIA - IIIB according to the American Joint Committee on Cancer staging system(AJCC),9th edition.
  • There is no disease recurrence (including local recurrence) after radical surgical resection (R0) treatment, and the estimated time of apheresis is within one year after the operation.
  • Previous tests for driver gene mutations (e.g., EGFR, ALK) were negative, and PD-L1 expression in tumor tissues was negative as detected.
  • Platinum-based chemotherapy (one to four cycles) has been completed before screening.
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  • The ECOG performance status score is ≤1 point, the expected survival time is ≥12 months, and follow-up can be conducted as stipulated in the protocol.
  • Major organ functions must be normal (no corrective treatment with any blood components, cell growth factors, or albumin infusion within 14 days before obtaining laboratory tests) and meet the following requirements: White blood cells (WBC) ≥3.5×109 cells/L, lymphocytes (LYM) ≥0.8×109 cells/L, platelets (PLT) ≥80×109 cells/L, absolute neutrophil count ≥1.5×109 cells/L, hemoglobin ≥90g/L; Total bilirubin ≤1.5×upper limit of normal value (ULN), alanine aminotransferase (ALT) ≤2.5×ULN, aspartate aminotransferase (AST) ≤2.5×ULN; Creatinine ≤1.0×ULN, or creatinine clearance rate ≥60mL/min (using the Cockcroft-Gault method); International Normalized Ratio (INR) ≤1.5.
  • Participants must have sufficient venous access for the apheresis.
  • Eligible participants with fertility (both male and female) must agree to use reliable contraceptive methods (hormones or barrier methods or abstinence) during the trial and for at least one year after the last reinfusion of SDTM001 injection; Female participants within childbearing age must have a negative pregnancy blood test within 7 days prior to enrollment; Male participants were not allowed to donate sperm from the first infusion to one year after the last infusion.

Who cannot join

  • Participants who have participated in other clinical trials of investigational agents or devices for therapeutic intent within 4 weeks prior to screening.
  • Participants who have received cancer treatment such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks prior to screening.
  • Participants who underwent gene-modified anti-tumor immune cell therapy (e.g., CAR-T cells, CAR-NK cells) within one year or non-gene-modified therapy (e.g., NK cells, DC cells, DC-CIK cells) within half a year prior to screening.
  • Participants with impaired cardiac function or significant cardiovascular diseases, including any of the following:
  • 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.
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  • 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:
  • Malignant tumors with no recurrence for ≥5 years after radical treatment
  • Cured cervical cancer or breast carcinoma in situ, basal cell carcinoma or squamous cell carcinoma.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lina Sun contact

028-87586128

sunlina@cytocraft.cn

China1 site, 1 recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610000

    Yongsheng Wang, 18980602258, wangy756@163.com

    Recruiting

Other trials in China

About this study

Official title: Phase I Clinical Trial of SDTM001 Injection as Adjuvant Treatment for NSCLC Patients With Driver-gene-negative and Negative PD-L1 Expression After Radical Surgical Resection

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).

Being tested
SDT-M001 injection
Keywords
Non-Small Cell Lung Cancer, SDT-M001, Cascade primed immune cells, CAPRI
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SDT-M001 injectionBiological

    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.

Study groups in NCT07096882
Study groupRoleWhat they receive
SDT-M001 injectionExperimentalNot described
Receives: Biological: SDT-M001 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment up to 24 Months After the end of the last infusion

  2. Tolerability of SDT-M001 injection

    The number and severity of dose-limiting toxicity (DLT) events. Calculate the incidence of DLT.

    Measured: From enrollment to 28 days after the end of the last infusion

  3. 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.

    Measured: Until the end of the study

Secondary outcomes (1)

  1. Therapeutic effect evaluation

    Efficacy evaluation will be conducted according to the RECIST 1.1 criteria.

    Measured: From enrollment up to 24 Months After the end of the last infusion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2025
  2. Study start26 Jul 2025 (estimated)
  3. Primary completion26 Jun 2027 (estimated)
  4. Study completion26 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07096882
Sponsor's protocol ID
SDTM001-2024
Status last verified
Jul 2025
First submitted
24 Jul 2025
Last updated
31 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SDT-M001 injection in people with Non-Small Cell Lung Cancer, run by Cytocraft Biopharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lina Sun (028-87586128, sunlina@cytocraft.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety profile of SDT-M001 injection (time frame: From enrollment up to 24 Months After the end of the last infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07096882.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.

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