Solid TumorDC-CTLNCT06524024
Clinical Study of Tumor Polypeptide DC-CTL in the Treatment of Solid Tumors
A study testing Tumor polypeptide pool induced DC-CTL cell injection in people with Solid Tumor, run by Zhengzhou Revo-Gene Technology Co., LTD.
Trial summary
This clinical study is a real-world exploratory study to observe the safety and initial effectiveness of DC-CTL cells combined with conventional anti-tumor therapy in patients with colorectal cancer, esophageal cancer, lung cancer, liver cancer, breast cancer and other solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Tumor polypeptide pool induced DC-CTL cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Apr 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old, gender is not limited;
- Patients clinically diagnosed with solid tumors such as colorectal cancer, esophageal cancer, lung cancer, liver cancer, breast cancer, etc., who need routine anti-tumor therapy;
- KPS score ≥80 (Appendix 1), expected survival ≥3 months;
- If imaging is available, the target lesion can be measured by conventional CT or MRI≥10 mm, and the short diameter of lymph node ≥15mm;
- Liver function: TBIL≤3ULN, AST, ALT ≤2.5ULN; Renal function: Cr≤1.25ULN; Blood routine: WBC ≥ 4.0×109/L, Hb ≥90 g/L, PLT ≥ 80×109/L;
- Good cardiac function (LVEF≥ 50%);
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- The peripheral superficial veins of the study participants were smooth, which could meet the needs of intravenous infusion;
- No history of other malignant tumors, except for cured carcinoma in situ and papillary thyroid carcinoma;
- Study participants agree to use a reliable contraceptive method for contraception from the time of signing the informed consent to the entire clinical study;
- Study participants agree to participate in the clinical study and sign the Informed Consent form.
Who cannot join
- Pregnant or lactating women (women of childbearing age need to do pregnancy tests);
- Had a serious, uncontrolled infectious disease (bacterial, viral, or fungal infection) within 4 weeks prior to enrollment;
- have chronic active hepatitis, AIDS or syphilis;
- have a serious autoimmune disease or immunodeficiency disease (such as systemic lupus erythematosus, inflammatory bowel disease, multiple sclerosis, rheumatoid arthritis, psoriasis);
- Severe allergy;
- serious mental disorders;
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- suffering from serious heart, liver, kidney dysfunction, serious uncontrollable diabetes and other diseases;
- Patients who had systematically used large amounts of glucocorticoids in the 4 weeks prior to enrollment (except those who used inhaled hormones);
- Those who have previously been treated with other gene products;
- Other investigators consider it inappropriate to participate in the study, or other circumstances that affect the analysis of the results of this clinical study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This clinical study is a real-world exploratory study to observe the safety and initial effectiveness of DC-CTL cells combined with conventional anti-tumor therapy in patients with colorectal cancer, esophageal cancer, lung cancer, liver cancer, breast cancer and other solid tumors.
Read the detailed description
This clinical study is a real-world exploratory study to observe the safety and initial effectiveness of DC-CTL cells combined with conventional anti-tumor therapy in patients with colorectal cancer, esophageal cancer, lung cancer, liver cancer, breast cancer and other solid tumors. In this study, DC-CTL cells were injected once a day for two consecutive days, 1-2 days after study participants received a conventional antitumor regimen, and subcutaneous injections of DC cells were administered before a second infusion of DC-CTL cells. A total of about 4-6 cycles of cell infusion are required, and the specific number of infusion and the composition of the peptide pool are determined by the investigator based on clinical needs and test results. After the cells have been transfused, their safety is examined first, and their effectiveness is evaluated during follow-up. According to the needs, this study plans to enroll about 20-200 patients with solid tumors such as colorectal cancer, esophageal cancer, lung cancer, liver cancer, and breast cancer. If the disease progresses during treatment, it is evaluated comprehensively by the investigator according to the clinical situation to determine whether the patient can be withdrawn from the study. Study participants in the follow-up phase who develop disease progression, begin other anti-tumor therapy without reaching disease progression after infusion, and voluntarily request to withdraw from the follow-up phase will be withdrawn from the follow-up phase and will be followed for survival only.
- Conditions
- Solid Tumor
- Being tested
- Tumor polypeptide pool induced DC-CTL cell injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor polypeptide pool induced DC-CTL cell injectionBiological
In this study, DC-CTL cells were injected once a day for two consecutive days, 1-2 days after study participants received a conventional antitumor regimen, and subcutaneous injections of DC cells were administered before a second infusion of DC-CTL cells. A total of about 4-6 cycles of cell infusion are required
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Biological: DC-CTL DC combined with CTL Receives: Biological: Tumor polypeptide pool induced DC-CTL cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression free survival time
Measured: From the time of the first cell transfusion to the time of the subject's death due to any cause, up to 2 years after the subject received the last treatment
Secondary outcomes (1)
OS
over all survival time
Measured: From the time of the first cell transfusion to the time of the subject's death due to any cause, up to 2 years after the subject received the last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Oct 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhengzhou Revo-Gene Technology Co., LTD
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Yi Zhang, professor, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524024
- Sponsor's protocol ID
- RG2401
- Acronym
- DC-CTL
- Status last verified
- Aug 2026
- First submitted
- 16 Jul 2024
- Last updated
- 2 Sep 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 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Tumor Polypeptide DC-CTL in the Treatment of Solid Tumors
- ClinicalTrials.gov ID
- NCT06524024
- Acronym / sponsor ID
- DC-CTL / RG2401
- Conditions
- Solid Tumor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhengzhou Revo-Gene Technology Co., LTDResearch network
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 29 Jul 2024 (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 clinical study is a real-world exploratory study to observe the safety and initial effectiveness of DC-CTL cells combined with conventional anti-tumor therapy in patients with colorectal cancer, esophageal cancer, lung cancer, liver cancer, breast cancer and other solid tumors.
Detailed description
This clinical study is a real-world exploratory study to observe the safety and initial effectiveness of DC-CTL cells combined with conventional anti-tumor therapy in patients with colorectal cancer, esophageal cancer, lung cancer, liver cancer, breast cancer and other solid tumors. In this study, DC-CTL cells were injected once a day for two consecutive days, 1-2 days after study participants received a conventional antitumor regimen, and subcutaneous injections of DC cells were administered before a second infusion of DC-CTL cells. A total of about 4-6 cycles of cell infusion are required, and the specific number of infusion and the composition of the peptide pool are determined by the investigator based on clinical needs and test results. After the cells have been transfused, their safety is examined first, and their effectiveness is evaluated during follow-up. According to the needs, this study plans to enroll about 20-200 patients with solid tumors such as colorectal cancer, esophageal cancer, lung cancer, liver cancer, and breast cancer. If the disease progresses during treatment, it is evaluated comprehensively by the investigator according to the clinical situation to determine whether the patient can be withdrawn from the study. Study participants in the follow-up phase who develop disease progression, begin other anti-tumor therapy without reaching disease progression after infusion, and voluntarily request to withdraw from the follow-up phase will be withdrawn from the follow-up phase and will be followed for survival only.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: Tumor polypeptide pool induced DC-CTL cell injectionBiological: DC-CTL DC combined with CTL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years old, gender is not limited;
- Patients clinically diagnosed with solid tumors such as colorectal cancer, esophageal cancer, lung cancer, liver cancer, breast cancer, etc., who need routine anti-tumor therapy;
- KPS score ≥80 (Appendix 1), expected survival ≥3 months;
- If imaging is available, the target lesion can be measured by conventional CT or MRI≥10 mm, and the short diameter of lymph node ≥15mm;
- Liver function: TBIL≤3ULN, AST, ALT ≤2.5ULN; Renal function: Cr≤1.25ULN; Blood routine: WBC ≥ 4.0×109/L, Hb ≥90 g/L, PLT ≥ 80×109/L;
Key exclusion criteria (10 listed)
- Pregnant or lactating women (women of childbearing age need to do pregnancy tests);
- Had a serious, uncontrolled infectious disease (bacterial, viral, or fungal infection) within 4 weeks prior to enrollment;
- have chronic active hepatitis, AIDS or syphilis;
- have a serious autoimmune disease or immunodeficiency disease (such as systemic lupus erythematosus, inflammatory bowel disease, multiple sclerosis, rheumatoid arthritis, psoriasis);
- Severe allergy;
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 |
|---|---|---|
| Tumor polypeptide pool induced DC-CTL cell injectionIn this study, DC-CTL cells were injected once a day for two consecutive days, 1-2 days after study participants received a conventional antitumor regimen, and subcutaneous injections of DC cells were administered before a second infusion of DC-CTL cells. A total of about 4-6 cycles of cell infusion are required | Biological | Treatment |
Primary outcome
PFS
Time frame: From the time of the first cell transfusion to the time of the subject's death due to any cause, up to 2 years after the subject received the last treatment
progression free survival time
1 secondary outcome
OS
Time frame: From the time of the first cell transfusion to the time of the subject's death due to any cause, up to 2 years after the subject received the last treatment
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 2 Sep 2026.
- Individual participant dataSharing planned: No
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
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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.
Yi Zhang, professor principal investigator
The First Affiliated Hospital of Zhengzhou University
Questions about this trial
What is this clinical trial studying?
A study testing Tumor polypeptide pool induced DC-CTL cell injection in people with Solid Tumor, run by Zhengzhou Revo-Gene Technology Co., LTD.
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 10 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 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Hui Zhao, PhD (0371-63290608, revogene@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: From the time of the first cell transfusion to the time of the subject's death due to any cause, up to 2 years after the subject received the last treatment). 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 2 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.