Colorectal NeoplasmsPhase 1NCT07903857
SND002 Cell Injection in Participants With Advanced Malignant Solid Tumors
A Phase 1 study testing SND002 Cell Injection in people with Colorectal Neoplasms and Stomach Neoplasms, run by Guizhou Sinorda Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
This is a phase 1, multicenter, open-label, single-arm study evaluating SND002 Cell Injection in participants with advanced malignant solid tumors that have progressed after standard treatment or for whom no standard treatment is available. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Neoplasms, Stomach Neoplasms, Solid Tumor Malignancies
- What is being tested?
- SND002 Cell Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesChina
- Study dates
- 1 Dec 2026to 28 Feb 2030
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of written informed consent before any study-specific procedure, and ability to complete the study procedures and follow-up assessments.
- Age 18 to 80 years inclusive at the time of informed consent. Participants older than 80 years may be enrolled at the joint discretion of the investigator and the sponsor.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Part A (dose escalation): cytologically or histologically confirmed advanced malignant solid tumor, including but not limited to gastrointestinal tumors (colorectal, gastric, pancreatic, hepatic, and biliary tract), gynecologic tumors (cervical, ovarian, and endometrial), breast cancer, malignant melanoma, and lung cancer. Prior therapy must meet at least one of the following: (a) at least one line of systemic standard therapy for advanced or metastatic disease, with disease progression during or after the last dose, or intolerance (Grade 3 or higher irreversible toxicity); (b) no recognized standard treatment available as judged by the investigator; (c) inability to receive current standard treatment for specific reasons.
- Part B (expansion), cohort 1 (colorectal cancer): at least two lines of prior systemic standard therapy, including a fluoropyrimidine plus oxaliplatin and/or irinotecan, with or without targeted therapy (bevacizumab or cetuximab) and with or without immunotherapy (programmed cell death protein 1 or programmed death-ligand 1 inhibitors; microsatellite instability-high or mismatch repair-deficient tumors must have received this therapy), with disease progression or intolerance during or after the last dose.
- Part B, cohort 2 (gastric cancer): at least two lines of prior systemic standard therapy, including a platinum agent and/or a fluoropyrimidine, with or without immunotherapy (programmed cell death protein 1 or programmed death-ligand 1 inhibitors) and with or without a taxane; human epidermal growth factor receptor 2-positive tumors must have received anti-human epidermal growth factor receptor 2 therapy, with disease progression or intolerance during or after the last dose.
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- Part B, cohort 3 (other solid tumors): tumors anticipated to respond based on dose-escalation data, potentially including malignant melanoma, pancreatic cancer, hepatic cancer, biliary tract cancer, cervical cancer, ovarian cancer, endometrial cancer, breast cancer, and lung cancer; at least one line of prior standard therapy according to the relevant guideline, with disease progression or intolerance during or after the last dose.
- Availability of at least one draining lymph node suitable for product manufacture, obtainable by conventional surgery or interventional procedure, or use of stored draining lymph node cells. Sentinel lymph node tissue is preferred when obtainable. The interval from prior radiotherapy or radiofrequency ablation to collection should preferably exceed 3 months.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), excluding the lesion used for lymph node collection, which may serve only as a non-target lesion even if measurable.
- Life expectancy of at least 3 months.
- Adequate organ function, with laboratory results meeting all of the following within 14 days before enrollment and without platelet transfusion or colony-stimulating factor administration during that period:
- Absolute neutrophil count at least 1.0x10^9/L.
- Platelet count at least 80x10^9/L.
- Hemoglobin at least 80 g/L.
- Serum total bilirubin no more than 1.5 times the upper limit of normal (ULN); no more than 3 times ULN in participants with Gilbert syndrome or hepatic metastasis.
- Alanine aminotransferase and aspartate aminotransferase no more than 2.5 times ULN; no more than 5 times ULN in participants with hepatic metastasis.
- International normalized ratio no more than 1.5 times ULN and activated partial thromboplastin time no more than 1.5 times ULN, except in participants receiving anticoagulation.
- Creatinine clearance at least 60 mL/min calculated by the Cockcroft-Gault formula.
- Toxicities from prior therapy resolved to Grade 1 or lower before enrollment, except alopecia and Grade 2 or lower neuropathy caused by chemotherapy.
- Negative serum pregnancy test within 7 days before enrollment for women of childbearing potential. All participants of childbearing potential must agree to use effective contraception from enrollment until at least 6 months after SND002 Cell Injection infusion. A woman is considered not of childbearing potential if she meets at least one of the following: prior hysterectomy or bilateral oophorectomy; medically confirmed ovarian failure; medically confirmed physiological amenorrhea for at least 12 consecutive months, excluding chemotherapy, radiotherapy, or sex hormone therapy and other pathological causes.
- Ability to recognize and comply with the protocol as judged by the investigator.
Who cannot join
- More than 3 untreated central nervous system metastases at screening. Participants with 3 or fewer central nervous system metastases may be enrolled if the largest diameter is less than 1 cm, there is no peritumoral edema on brain imaging, and there is no evidence of progressive central nervous system disease on brain imaging at least 3 months after treatment.
- Prior adoptive cell therapy, including dendritic cells, cytokine-induced killer cells, T cells, natural killer cells, or chimeric antigen receptor T cells.
- Systemic antitumor therapy within 4 weeks before preconditioning, except bridging therapy. For prior nitrosourea or mitomycin chemotherapy, the interval to preconditioning must be at least 6 weeks. For prior small-molecule targeted therapy, the interval must be at least 5 half-lives.
- Systemic corticosteroids at a dose of 10 mg/day or more of prednisone or equivalent, or other immunosuppressive therapy, within 2 weeks before preconditioning, except inhaled, topical, or physiological replacement therapy.
- Major surgery within 4 weeks before screening, or planned major surgery during the study other than the protocol-specified procedure for lymph node collection.
- Other malignancy within 5 years before screening or concurrently, except malignancy treated locally and cured with no antitumor therapy required for at least 1 year, such as non-melanoma skin cancer or cervical carcinoma in situ.
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- Active autoimmune disease, a history of autoimmune disease, or a condition requiring systemic corticosteroids or immunosuppressive therapy at more than 10 mg/day of prednisone or equivalent.
- History of organ transplantation or hematopoietic stem cell transplantation.
- Infectious disease within 1 year before screening, including positive human immunodeficiency virus, syphilis, or cytomegalovirus DNA; active pulmonary tuberculosis, or a history of active pulmonary tuberculosis for more than 1 year without adequate treatment; positive hepatitis B surface antigen, or positive hepatitis B core antibody with hepatitis B virus DNA above the lower limit of normal at the study site; positive hepatitis C virus antibody with hepatitis C virus RNA above the lower limit of normal. Inactive carriers may participate if antiviral therapy is arranged as appropriate and nucleic acid levels are monitored periodically during the study.
- Live or attenuated vaccine within 4 weeks before preconditioning.
- Clinically significant cardiovascular disease, including but not limited to:
- Congestive heart failure classified as New York Heart Association class higher than 2.
- Unstable angina.
- Myocardial infarction within the past 3 months.
- Any supraventricular or ventricular arrhythmia requiring treatment or intervention.
- Interstitial pneumonia, clinically significant active pneumonia at screening, or other respiratory disease that significantly affects lung function.
- Refractory or intractable epilepsy, pleural effusion, ascites, or pericardial effusion not controlled by medication, active gastrointestinal bleeding, or any contraindication to interleukin-2.
- History of hypersensitivity to any component of the study drugs, including but not limited to SND002 Cell Injection, cyclophosphamide, fludarabine, interleukin-2, dimethyl sulfoxide (DMSO), human serum albumin, or gentamicin.
- Treatment with another investigational product within 4 weeks before screening, or planned participation in another investigational product study during the study.
- Any other condition the investigator considers unsuitable for participation, for example Grade 3 or higher adverse reactions with prior immunotherapy.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Guiyang Second People's Hospital
Guiyang, Guizhou, 550081
Li Yang, +86-851-84103364, gyseylcsyjgb@163.com
Wenbin Li, MD
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Lulu Liu, MD, +86-571-87236560, liululu2001@zju.edu.cn
Weijia Fang, MD
About this study
Official title: A Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of SND002 Cell Injection in Participants With Advanced Malignant Solid Tumors
This is a phase 1, multicenter, open-label, single-arm study evaluating SND002 Cell Injection in participants with advanced malignant solid tumors that have progressed after standard treatment or for whom no standard treatment is available.
SND002 Cell Injection is an investigational product made from a participant's own immune cells (T cells). These cells are collected from a lymph node that drains the tumor, expanded in a laboratory, and then given back to the same participant by intravenous infusion. Because the cells come from the participant, the approach is intended to help the participant's immune system recognize and attack the tumor.
Read more
The study has two parts. In Part A, small groups of participants receive increasing numbers of cells to identify the dose range that is safest and best tolerated. In Part B, additional participants with colorectal cancer, gastric cancer, or other solid tumors receive the dose range selected in Part A, to learn more about antitumor activity.
Before the infusion, participants receive a short course of chemotherapy to prepare the body for the cells. After the infusion, participants receive interleukin-2 injections for several days and are monitored closely. Safety is assessed for 28 days after the infusion, and participants are then followed for up to 1 year to assess tumor response and survival.
The main questions are (1) what side effects occur, how severe they are, and what dose range is recommended for further study, and (2) in the expansion part, how many participants experience a reduction in tumor size.
Approximately 69 to 78 participants will be enrolled at multiple hospitals in China. Follow-up continues for up to 1 year after the infusion.
Read the detailed description
This is a multicenter, single-arm, open-label, first-in-human phase 1 study conducted in two sequential parts: a dose-escalation part (Part A) and a clinical expansion part (Part B). All participants receive a single intravenous infusion of SND002 Cell Injection. Part B is initiated only after the recommended dose range has been identified in Part A.
Part A: Dose Escalation
Part A uses a modified 3+3 design with three planned cell-dose ranges: 5x10^9 to 1x10^10 cells, 1x10^10 to 2.5x10^10 cells, and 2.5x10^10 to 5x10^10 cells. Each cohort enrolls 3 to 6 participants, and 9 to 18 participants are planned in total. Participants are assigned to a cohort according to the number of cells obtained during product manufacture. The first participant of the next cohort may be dosed only after the first participant of the preceding cohort has completed the dose-limiting toxicity (DLT) observation period; the remaining participants within a cohort may be enrolled and observed concurrently. Dose escalation is guided by a Safety Review Committee (SRC). If two or more DLTs assessed as related to SND002 Cell Injection occur in a cohort, escalation to the next higher cohort is not performed, and the SRC determines whether to reduce the dose or to stop the study. If two or more of six participants in a dose range experience a DLT, that range is defined as the maximum tolerated dose. If no maximum tolerated dose is reached at the highest planned dose range, the SRC decides whether to continue escalation and at what dose, based on the available safety, pharmacokinetic, and preliminary efficacy data.
Part B: Clinical Expansion
Part B is planned to include three cohorts, comprising colorectal cancer, gastric cancer, and other solid tumor types, with approximately 20 participants per cohort. The dose range administered in Part B is the range recommended at the completion of Part A. The final number of cohorts and the dosing regimen will be determined from the cumulative data obtained during dose escalation and expansion. The SRC may adjust the dose range, sample size, and sampling time points as data accumulate.
Participant Pathway and Treatment
Screening is completed within 14 days before fresh lymph node collection. The pretreatment period lasts up to 4 weeks, during which the tumor-draining lymph node is surgically collected and SND002 Cell Injection is manufactured from the participant's own T cells. Before infusion, participants receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine over 4 days (Day -5 to Day -2). SND002 Cell Injection is administered as a single intravenous infusion on Day 0. Subcutaneous low-dose interleukin-2 is given every 12 hours starting 3 to 24 hours after infusion, for up to 6 doses. Participants are monitored closely after infusion; inpatient observation following infusion is recommended, and its duration is determined by the investigator.
Safety Monitoring
The DLT observation period extends from the start of lymphodepleting chemotherapy (Day -5) through Day 28 after infusion. Adverse events are collected from signature of the informed consent form through the end-of-study or early-termination visit and are followed until resolution, stabilization, return to baseline, reasonable explanation, loss to follow-up, or initiation of new antitumor therapy, whichever occurs first.
Efficacy Assessment
Tumor response is assessed by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Imaging is performed every 8 weeks during the first 24 weeks after infusion and every 12 weeks thereafter. Complete or partial responses must be confirmed on a subsequent assessment at least 4 weeks later, and stable disease must persist for at least 6 weeks. Participants with documented disease progression continue to be followed for survival, which may be done by telephone, for up to 1 year after infusion.
Endpoints and Study Duration
The primary endpoints are safety, comprising adverse events, laboratory abnormalities, electrocardiogram findings, physical examination, and vital signs, and determination of the recommended dose range in Part A, and objective response rate and disease control rate in Part B. Secondary endpoints include pharmacokinetics, assessed by characterizing SND002-specific T-cell receptor clones in peripheral blood; pharmacodynamics, assessed by immune cell subsets and serum cytokine levels; time to response; duration of response; progression-free survival; 1-year progression-free survival rate; overall survival; and 1-year overall survival rate. The study ends when the last participant completes the scheduled follow-up visits, is lost to follow-up, withdraws consent, or dies, or 1 year after infusion, or upon early termination of the study, whichever occurs first. Participants who remain alive 1 year after infusion may enter a separate extension study.
- Being tested
- SND002 Cell Injection
- Keywords
- SND002, Tumor-Draining Lymph Node, Adoptive Cell Therapy, Autologous T Cell Therapy
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SND002 Cell InjectionBiological
SND002 Cell Injection is an autologous cell therapy product derived from the participant's own T lymphocytes. The cells are obtained from a fresh tumor-draining lymph node collected during surgery, expanded in vitro, and formulated for intravenous administration. Each participant receives a single intravenous infusion on Day 0. The dose is defined by the number of cells administered and is selected from three planned cell-dose ranges in the dose-escalation part of the study. No allogeneic or off-the-shelf product is used; each preparation is manufactured from, and administered to, the same individual.
| Study group | Role | What they receive |
|---|---|---|
| SND002 Cell Injection | Experimental | This single arm comprises all participants enrolled in the study. Every participant receives SND002 Cell Injection as the sole study treatment; no comparator is administered. Lymphodepleting chemotherapy (cyclophosphamide and fludarabine) is given before infusion to prepare for cell administration, and low-dose interleukin-2 is given after infusion as supportive therapy; both are components of the same treatment regimen rather than separate study arms. The cell dose administered is determined by the cell-dose range to which the participant is assigned in Part A, and in Part B participants are enrolled by tumor type. Receives: Biological: SND002 Cell Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities
Safety was assessed by treatment-emergent adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 6.0, serious adverse events, dose-limiting toxicities, clinical laboratory tests (hematology, serum chemistry, coagulation, urinalysis, cardiac enzymes, troponin, and thyroid function), 12-lead electrocardiogram, physical examination, and vital signs.
Measured: From the start of lymphodepleting chemotherapy (Day -5) through Day 28 after SND002 Cell Injection infusion
Recommended cell-dose range (cells) for further study as determined by the Safety Review Committee
The recommended dose was defined as the cell-dose range selected for the expansion part on the basis of dose-limiting toxicities observed during dose escalation under a modified 3+3 design.
Measured: Through completion of the dose-escalation part (Part A)
Percentage of participants with an objective response (complete response or partial response) assessed by RECIST 1.1
Objective response rate was defined as the proportion of participants whose best overall response was complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), as assessed by the investigator.
Measured: From SND002 Cell Injection infusion through Week 24
Percentage of participants with disease control (complete response, partial response, or stable disease) assessed by RECIST 1.1
Disease control rate was defined as the proportion of participants whose best overall response was CR, PR, or stable disease (SD) according to RECIST 1.1. Stable disease was required to persist for at least 6 weeks.
Measured: From SND002 Cell Injection infusion through Week 24
Secondary outcomes (9)
Progression-free survival (time from infusion to progression or death from any cause) assessed by the investigator according to RECIST 1.1
Measured: From infusion until disease progression or death from any cause, whichever occurs first (up to 1 year)
Percentage of participants alive and progression-free at 1 year after infusion
Measured: At 1 year after infusion
Overall survival (time from infusion to death from any cause)
Measured: From infusion until death from any cause (up to 1 year)
Percentage of participants alive at 1 year after infusion
Measured: At 1 year after infusion
Time to response in participants with an objective response
Measured: From infusion to first documentation of CR or PR (up to 1 year)
Duration of response in participants with an objective response
Measured: From first documentation of CR or PR to first documentation of progression or death, whichever occurs first (up to 1 year)
Change from baseline in the percentage of SND002-specific T-cell receptor clones in peripheral blood
Change from baseline in the percentage of SND002-specific T-cell receptor clones in peripheral blood.
Measured: Before lymphodepleting chemotherapy (within 3 days) and on Day 7, Week 8, Week 24, Week 48, and Week 52
Change from baseline in peripheral blood immune cell subsets
CD45+CD3+, CD3-CD19+, CD3-CD56+, CD3-CD14+, CD8+CD39-CD69-, CD4+CD39-CD69-, CD8+PD1+, CD4+PD1+, CD8+TIGIT+, and CD4+TIGIT+
Measured: Before lymphodepleting chemotherapy (within 3 days) and on Day 7, Week 8, Week 24, Week 48, and Week 52
Change from baseline in serum cytokine concentrations
Including IFN-γ, TNF-α, IL-2, IL-6, GM-CSF, IL-4, IL-5, IL-8, IL-13, VEGF, MIP-1α, and IP-10
Measured: Before lymphodepleting chemotherapy (within 3 days) and on Day 7, Week 8, Week 24, Week 48, and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Aug 2029 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- All participants receive a single intravenous infusion of SND002 Cell Injection; there is no parallel or comparator group. Within this single group, Part A assigns participants to one of three cell-dose ranges according to the number of cells obtained during product manufacture, and Part B enrolls separate cohorts by tumor type (colorectal cancer, gastric cancer, and other solid tumors). These dose ranges and tumor cohorts are subgroups within the same arm rather than independent treatment assignments; therefore, the study is recorded as a single-group study with one arm.
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guizhou Sinorda Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903857
- Sponsor's protocol ID
- SND-LNT-101
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of SND002 Cell Injection in Participants With Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT07903857
- Acronym / sponsor ID
- SND-LNT-101
- Keywords
- SND002, Tumor-Draining Lymph Node, Adoptive Cell Therapy, Autologous T Cell Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Guizhou Sinorda Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1, multicenter, open-label, single-arm study evaluating SND002 Cell Injection in participants with advanced malignant solid tumors that have progressed after standard treatment or for whom no standard treatment is available.
SND002 Cell Injection is an investigational product made from a participant's own immune cells (T cells). These cells are collected from a lymph node that drains the tumor, expanded in a laboratory, and then given back to the same participant by intravenous infusion. Because the cells come from the participant, the approach is intended to help the participant's immune system recognize and attack the tumor.
The study has two parts. In Part A, small groups of participants receive increasing numbers of cells to identify the dose range that is safest and best tolerated. In Part B, additional participants with colorectal cancer, gastric cancer, or other solid tumors receive the dose range selected in Part A, to learn more about antitumor activity.
Before the infusion, participants receive a short course of chemotherapy to prepare the body for the cells. After the infusion, participants receive interleukin-2 injections for several days and are monitored closely. Safety is assessed for 28 days after the infusion, and participants are then followed for up to 1 year to assess tumor response and survival.
The main questions are (1) what side effects occur, how severe they are, and what dose range is recommended for further study, and (2) in the expansion part, how many participants experience a reduction in tumor size.
Approximately 69 to 78 participants will be enrolled at multiple hospitals in China. Follow-up continues for up to 1 year after the infusion.
Detailed description
This is a multicenter, single-arm, open-label, first-in-human phase 1 study conducted in two sequential parts: a dose-escalation part (Part A) and a clinical expansion part (Part B). All participants receive a single intravenous infusion of SND002 Cell Injection. Part B is initiated only after the recommended dose range has been identified in Part A.
Part A: Dose Escalation
Part A uses a modified 3+3 design with three planned cell-dose ranges: 5x10^9 to 1x10^10 cells, 1x10^10 to 2.5x10^10 cells, and 2.5x10^10 to 5x10^10 cells. Each cohort enrolls 3 to 6 participants, and 9 to 18 participants are planned in total. Participants are assigned to a cohort according to the number of cells obtained during product manufacture. The first participant of the next cohort may be dosed only after the first participant of the preceding cohort has completed the dose-limiting toxicity (DLT) observation period; the remaining participants within a cohort may be enrolled and observed concurrently. Dose escalation is guided by a Safety Review Committee (SRC). If two or more DLTs assessed as related to SND002 Cell Injection occur in a cohort, escalation to the next higher cohort is not performed, and the SRC determines whether to reduce the dose or to stop the study. If two or more of six participants in a dose range experience a DLT, that range is defined as the maximum tolerated dose. If no maximum tolerated dose is reached at the highest planned dose range, the SRC decides whether to continue escalation and at what dose, based on the available safety, pharmacokinetic, and preliminary efficacy data.
Part B: Clinical Expansion
Part B is planned to include three cohorts, comprising colorectal cancer, gastric cancer, and other solid tumor types, with approximately 20 participants per cohort. The dose range administered in Part B is the range recommended at the completion of Part A. The final number of cohorts and the dosing regimen will be determined from the cumulative data obtained during dose escalation and expansion. The SRC may adjust the dose range, sample size, and sampling time points as data accumulate.
Participant Pathway and Treatment
Screening is completed within 14 days before fresh lymph node collection. The pretreatment period lasts up to 4 weeks, during which the tumor-draining lymph node is surgically collected and SND002 Cell Injection is manufactured from the participant's own T cells. Before infusion, participants receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine over 4 days (Day -5 to Day -2). SND002 Cell Injection is administered as a single intravenous infusion on Day 0. Subcutaneous low-dose interleukin-2 is given every 12 hours starting 3 to 24 hours after infusion, for up to 6 doses. Participants are monitored closely after infusion; inpatient observation following infusion is recommended, and its duration is determined by the investigator.
Safety Monitoring
The DLT observation period extends from the start of lymphodepleting chemotherapy (Day -5) through Day 28 after infusion. Adverse events are collected from signature of the informed consent form through the end-of-study or early-termination visit and are followed until resolution, stabilization, return to baseline, reasonable explanation, loss to follow-up, or initiation of new antitumor therapy, whichever occurs first.
Efficacy Assessment
Tumor response is assessed by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Imaging is performed every 8 weeks during the first 24 weeks after infusion and every 12 weeks thereafter. Complete or partial responses must be confirmed on a subsequent assessment at least 4 weeks later, and stable disease must persist for at least 6 weeks. Participants with documented disease progression continue to be followed for survival, which may be done by telephone, for up to 1 year after infusion.
Endpoints and Study Duration
The primary endpoints are safety, comprising adverse events, laboratory abnormalities, electrocardiogram findings, physical examination, and vital signs, and determination of the recommended dose range in Part A, and objective response rate and disease control rate in Part B. Secondary endpoints include pharmacokinetics, assessed by characterizing SND002-specific T-cell receptor clones in peripheral blood; pharmacodynamics, assessed by immune cell subsets and serum cytokine levels; time to response; duration of response; progression-free survival; 1-year progression-free survival rate; overall survival; and 1-year overall survival rate. The study ends when the last participant completes the scheduled follow-up visits, is lost to follow-up, withdraws consent, or dies, or 1 year after infusion, or upon early termination of the study, whichever occurs first. Participants who remain alive 1 year after infusion may enter a separate extension study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive a single intravenous infusion of SND002 Cell Injection; there is no parallel or comparator group. Within this single group, Part A assigns participants to one of three cell-dose ranges according to the number of cells obtained during product manufacture, and Part B enrolls separate cohorts by tumor type (colorectal cancer, gastric cancer, and other solid tumors). These dose ranges and tumor cohorts are subgroups within the same arm rather than independent treatment assignments; therefore, the study is recorded as a single-group study with one arm.
| Arm | Type | Receives |
|---|---|---|
| SND002 Cell Injection | Experimental | Biological: SND002 Cell InjectionThis single arm comprises all participants enrolled in the study. Every participant receives SND002 Cell Injection as the sole study treatment; no comparator is administered. Lymphodepleting chemotherapy (cyclophosphamide and fludarabine) is given before infusion to prepare for cell administration, and low-dose interleukin-2 is given after infusion as supportive therapy; both are components of the same treatment regimen rather than separate study arms. The cell dose administered is determined by the cell-dose range to which the participant is assigned in Part A, and in Part B participants are enrolled by tumor type. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Provision of written informed consent before any study-specific procedure, and ability to complete the study procedures and follow-up assessments.
- Age 18 to 80 years inclusive at the time of informed consent. Participants older than 80 years may be enrolled at the joint discretion of the investigator and the sponsor.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Part A (dose escalation): cytologically or histologically confirmed advanced malignant solid tumor, including but not limited to gastrointestinal tumors (colorectal, gastric, pancreatic, hepatic, and biliary tract), gynecologic tumors (cervical, ovarian, and endometrial), breast cancer, malignant melanoma, and lung cancer. Prior therapy must meet at least one of the following: (a) at least one line of systemic standard therapy for advanced or metastatic disease, with disease progression during or after the last dose, or intolerance (Grade 3 or higher irreversible toxicity); (b) no recognized standard treatment available as judged by the investigator; (c) inability to receive current standard treatment for specific reasons.
- Part B (expansion), cohort 1 (colorectal cancer): at least two lines of prior systemic standard therapy, including a fluoropyrimidine plus oxaliplatin and/or irinotecan, with or without targeted therapy (bevacizumab or cetuximab) and with or without immunotherapy (programmed cell death protein 1 or programmed death-ligand 1 inhibitors; microsatellite instability-high or mismatch repair-deficient tumors must have received this therapy), with disease progression or intolerance during or after the last dose.
Key exclusion criteria (20 listed)
- More than 3 untreated central nervous system metastases at screening. Participants with 3 or fewer central nervous system metastases may be enrolled if the largest diameter is less than 1 cm, there is no peritumoral edema on brain imaging, and there is no evidence of progressive central nervous system disease on brain imaging at least 3 months after treatment.
- Prior adoptive cell therapy, including dendritic cells, cytokine-induced killer cells, T cells, natural killer cells, or chimeric antigen receptor T cells.
- Systemic antitumor therapy within 4 weeks before preconditioning, except bridging therapy. For prior nitrosourea or mitomycin chemotherapy, the interval to preconditioning must be at least 6 weeks. For prior small-molecule targeted therapy, the interval must be at least 5 half-lives.
- Systemic corticosteroids at a dose of 10 mg/day or more of prednisone or equivalent, or other immunosuppressive therapy, within 2 weeks before preconditioning, except inhaled, topical, or physiological replacement therapy.
- Major surgery within 4 weeks before screening, or planned major surgery during the study other than the protocol-specified procedure for lymph node collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SND002 Cell InjectionSND002 Cell Injection is an autologous cell therapy product derived from the participant's own T lymphocytes. The cells are obtained from a fresh tumor-draining lymph node collected during surgery, expanded in vitro, and formulated for intravenous administration. Each participant receives a single intravenous infusion on Day 0. The dose is defined by the number of cells administered and is selected from three planned cell-dose ranges in the dose-escalation part of the study. No allogeneic or off-the-shelf product is used; each preparation is manufactured from, and administered to, the same individual. | Biological | SND002 Cell Injection |
Primary outcome
Number of participants with treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities
Time frame: From the start of lymphodepleting chemotherapy (Day -5) through Day 28 after SND002 Cell Injection infusion
Safety was assessed by treatment-emergent adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 6.0, serious adverse events, dose-limiting toxicities, clinical laboratory tests (hematology, serum chemistry, coagulation, urinalysis, cardiac enzymes, troponin, and thyroid function), 12-lead electrocardiogram, physical examination, and vital signs.
Recommended cell-dose range (cells) for further study as determined by the Safety Review Committee
Time frame: Through completion of the dose-escalation part (Part A)
The recommended dose was defined as the cell-dose range selected for the expansion part on the basis of dose-limiting toxicities observed during dose escalation under a modified 3+3 design.
Percentage of participants with an objective response (complete response or partial response) assessed by RECIST 1.1
Time frame: From SND002 Cell Injection infusion through Week 24
Objective response rate was defined as the proportion of participants whose best overall response was complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), as assessed by the investigator.
Percentage of participants with disease control (complete response, partial response, or stable disease) assessed by RECIST 1.1
Time frame: From SND002 Cell Injection infusion through Week 24
Disease control rate was defined as the proportion of participants whose best overall response was CR, PR, or stable disease (SD) according to RECIST 1.1. Stable disease was required to persist for at least 6 weeks.
9 secondary outcomes
Progression-free survival (time from infusion to progression or death from any cause) assessed by the investigator according to RECIST 1.1
Time frame: From infusion until disease progression or death from any cause, whichever occurs first (up to 1 year)
Percentage of participants alive and progression-free at 1 year after infusion
Time frame: At 1 year after infusion
Overall survival (time from infusion to death from any cause)
Time frame: From infusion until death from any cause (up to 1 year)
Percentage of participants alive at 1 year after infusion
Time frame: At 1 year after infusion
Time to response in participants with an objective response
Time frame: From infusion to first documentation of CR or PR (up to 1 year)
Duration of response in participants with an objective response
Time frame: From first documentation of CR or PR to first documentation of progression or death, whichever occurs first (up to 1 year)
Change from baseline in the percentage of SND002-specific T-cell receptor clones in peripheral blood
Time frame: Before lymphodepleting chemotherapy (within 3 days) and on Day 7, Week 8, Week 24, Week 48, and Week 52
Change from baseline in peripheral blood immune cell subsets
Time frame: Before lymphodepleting chemotherapy (within 3 days) and on Day 7, Week 8, Week 24, Week 48, and Week 52
Change from baseline in serum cytokine concentrations
Time frame: Before lymphodepleting chemotherapy (within 3 days) and on Day 7, Week 8, Week 24, Week 48, and Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SND002 Cell Injection in people with Colorectal Neoplasms and Stomach Neoplasms, run by Guizhou Sinorda Pharmaceutical Co., Ltd. at 2 sites 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 21 inclusion and 20 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: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Yuan Yang, PhD (+86 851 8487 7184, yangy@sinorda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (time frame: From the start of lymphodepleting chemotherapy (Day -5) through Day 28 after SND002 Cell Injection infusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2026.