Solid CancersPhase 1dendritic cellNCT07479667
An Antibody-armored Dendritic Cell in Patients With Solid Tumors
A Phase 1 study testing Armored Dendritic Cell Injection in people with Solid Cancers and Adjuvant Therapy, run by Shanghai Cell Therapy Group Co.,Ltd at 1 site in China.
Trial summary
This study is a single-arm, open-label, single-administration dose-escalation study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Cancers, Adjuvant Therapy
- What is being tested?
- Armored Dendritic Cell Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2026to 30 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 80 years, body weight ≥ 40 kg; male or female, no gender restriction;
- ECOG performance status score of 0 to 1;
- Histopathologically confirmed solid tumors including pancreatic cancer, colorectal cancer (CRC), gastric cancer and other such malignancies;
- Having undergone R0 or R1 resection with completion of at least 4 cycles of standard postoperative adjuvant chemotherapy;
- Positive expression for at least one of TERT, P53, KRAS and Survivin;
- Sufficient venous access with no contraindications to peripheral blood mononuclear cell collection;
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- Adequate organ and bone marrow function:
- a) Platelet count ≥ 90×10⁹/L;
- b) Hemoglobin ≥ 90 g/L (no blood transfusion or erythropoietin dependence within 7 days);
- c) Mononuclear cell count ≥ 1.0×10⁹/L;
- d) International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × upper limit of normal (ULN);
- e) Serum creatinine ≤ 1.5 × upper limit of normal (ULN);
- f) Aminotransferases (AST, ALT) ≤ 2.5 × upper limit of normal (ULN);
- g) Total bilirubin ≤ 2 × upper limit of normal (ULN);
- h) Cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥ 50% as assessed by echocardiography within 1 month prior to enrollment;
- Able to understand the study requirements and considerations and provide informed consent to participate in the clinical study in accordance with the study requirements
- Subjects agree to use effective contraceptive measures for at least 6 months following dendritic cell (DC) injection.
Who cannot join
- Women who are pregnant or breastfeeding;
- Positive for human immunodeficiency virus (HIV) antibody or syphilis antibody; positive for hepatitis B surface antigen (HBsAg), positive for hepatitis B core antibody (anti-HBc) or hepatitis B e antibody (anti-HBe) with hepatitis B virus (HBV) DNA copy number above the lower limit of detection (LLOD) or ≥ 1000 copies/mL; or hepatitis C virus (HCV) RNA copy number above the LLOD;
- Prior treatment with any dendritic cell (DC) or other immune cell therapy;
- History of hypersensitivity to immunotherapy and related drugs, or history of severe allergic reactions;
- Uncontrolled active infection;
- Subjects with active autoimmune disease receiving relevant treatment; subjects with organ transplantation who are still on immunosuppressive agents; or subjects requiring long-term use of immunosuppressive agents (> 15 mg/day prednisone or equivalent glucocorticoid dose) and who have used them within 4 weeks prior to screening;
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- Presence of central nervous system (CNS) metastases and clinically significant CNS diseases;
- Received systemic anti-tumor therapy within 4 weeks prior to screening;
- Presence of residual lesions or unremoved foci on screening examinations (post-adjuvant chemotherapy / post-surgery), with imaging indicating local recurrence or confirmed distant metastasis;
- History of other active malignancies within 5 years (excluding cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, etc.);
- Clinically significant major cardiovascular diseases including:
- a) Symptomatic congestive heart failure
- b) Unstable angina pectoris
- c) Severe arrhythmia requiring pharmacotherapy
- d) Uncontrolled hypertension
- e) Myocardial infarction or ventricular arrhythmia within 6 months prior to screening;
- Any other conditions deemed by the investigator to render the subject ineligible for participation in the clinical study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Exploratory, Single-arm, Open-label Study to Evaluate the Safety and Tolerability of Antibody-armored Dendritic Cell Injection Following a Single Administration in Patients With Solid Tumors
This study is a single-arm, open-label, single-administration dose-escalation study.
- Conditions
- Solid Cancers, Adjuvant Therapy
- Being tested
- Armored Dendritic Cell Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Armored Dendritic Cell InjectionBiological
Armored dendritic cells are administered via multiple subcutaneous injections.
| Study group | Role | What they receive |
|---|---|---|
| Armored Dendritic Cell Injection | Experimental | Not described Receives: Biological: Armored Dendritic Cell Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
Measured: Day 0-Month 5
Evaluate the incidence and severity of adverse events
Adverse events (AEs), serious adverse events (SAEs) and laboratory abnormalities (including their types, frequencies and severity) will be collected. This includes the types, incidence and severity of adverse events, as well as clinically significant abnormal laboratory test results and abnormal physical examination findings that emerge after treatment. Clinical and laboratory adverse events will be primarily graded using Version 6.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). The causal relationship between adverse events and the dendritic cell (DC) product will be assessed by investigators in accordance with the causality evaluation criteria specified in the study protocol.
Measured: Day 0-Month 24
Secondary outcomes (6)
Cmax
Measured: day 0-day28
antigen-specific T-cell responses
Measured: day 0-Month 5
RFS
1- and 2-year recurrence-free survival rates (RFS)
Measured: day 0-Month 24
Tmax
Measured: day 0- day 28
Tlast
Measured: day 0-day 28
concentration of tumor markers
Measured: day 0-month 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start5 Feb 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid CancersStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Cell Therapy Group Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479667
- Sponsor's protocol ID
- JL104-A-01
- Acronym
- dendritic cell
- Status last verified
- Mar 2026
- First submitted
- 8 Feb 2026
- Last updated
- 18 Mar 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 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Single-arm, Open-label Study to Evaluate the Safety and Tolerability of Antibody-armored Dendritic Cell Injection Following a Single Administration in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT07479667
- Acronym / sponsor ID
- dendritic cell / JL104-A-01
- Conditions
- Solid Cancers, Adjuvant Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Shanghai Cell Therapy Group Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 18 Mar 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 study is a single-arm, open-label, single-administration dose-escalation study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Armored Dendritic Cell Injection | Experimental | Biological: Armored Dendritic Cell Injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Aged 18 to 80 years, body weight ≥ 40 kg; male or female, no gender restriction;
- ECOG performance status score of 0 to 1;
- Histopathologically confirmed solid tumors including pancreatic cancer, colorectal cancer (CRC), gastric cancer and other such malignancies;
- Having undergone R0 or R1 resection with completion of at least 4 cycles of standard postoperative adjuvant chemotherapy;
- Positive expression for at least one of TERT, P53, KRAS and Survivin;
Key exclusion criteria (17 listed)
- Women who are pregnant or breastfeeding;
- Positive for human immunodeficiency virus (HIV) antibody or syphilis antibody; positive for hepatitis B surface antigen (HBsAg), positive for hepatitis B core antibody (anti-HBc) or hepatitis B e antibody (anti-HBe) with hepatitis B virus (HBV) DNA copy number above the lower limit of detection (LLOD) or ≥ 1000 copies/mL; or hepatitis C virus (HCV) RNA copy number above the LLOD;
- Prior treatment with any dendritic cell (DC) or other immune cell therapy;
- History of hypersensitivity to immunotherapy and related drugs, or history of severe allergic reactions;
- Uncontrolled active infection;
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 |
|---|---|---|
| Armored Dendritic Cell InjectionArmored dendritic cells are administered via multiple subcutaneous injections. | Biological | Armored Dendritic Cell Injection |
Primary outcome
Maximum Tolerated Dose
Time frame: Day 0-Month 5
Evaluate the incidence and severity of adverse events
Time frame: Day 0-Month 24
Adverse events (AEs), serious adverse events (SAEs) and laboratory abnormalities (including their types, frequencies and severity) will be collected. This includes the types, incidence and severity of adverse events, as well as clinically significant abnormal laboratory test results and abnormal physical examination findings that emerge after treatment. Clinical and laboratory adverse events will be primarily graded using Version 6.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). The causal relationship between adverse events and the dendritic cell (DC) product will be assessed by investigators in accordance with the causality evaluation criteria specified in the study protocol.
6 secondary outcomes
Cmax
Time frame: day 0-day28
antigen-specific T-cell responses
Time frame: day 0-Month 5
RFS
Time frame: day 0-Month 24
Tmax
Time frame: day 0- day 28
Tlast
Time frame: day 0-day 28
concentration of tumor markers
Time frame: day 0-month 5
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 18 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Armored Dendritic Cell Injection in people with Solid Cancers and Adjuvant Therapy, run by Shanghai Cell Therapy Group 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 17 inclusion and 17 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 18 Mar 2026. 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 Xu Qing (13761325567, xuqing@shcell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (time frame: Day 0-Month 5). The study lists 2 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 18 Mar 2026.