Colorectal CancerPhase 1NCT07014878
A Study of DCTY1102 Injection in Participants With Advanced Solid Tumors
A Phase 1 study testing TCR-T cells in people with Colorectal Cancer and Lung Cancer, run by Beijing DCTY Biotech Co.,Ltd. at 2 sites in China.
Trial summary
This is a Phase 1/2, open-label, single-arm, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of DCTY1102 Injection in participants with advanced malignant tumors harboring KRAS/NRAS G12D mutations and positive for HLA-A11:01. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Cancer, Lung Cancer, Pancreatic Cancer
- What is being tested?
- TCR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesChina
- Study dates
- May 2026to Aug 2028
- 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
- Before conducting any research-related operations, an informed consent form (ICF) must be signed;
- Age should be between 18 and 70 years old;
- Participants with advanced malignant tumors (including but not limited to pancreatic cancer, colorectal cancer, lung cancer, etc.) diagnosed by histological or cytological methods, who have failed standard treatment (disease progression after treatment) or have treatment intolerance;
- Must meet the following two criteria simultaneously:
- 1) HLA-A11:01 genotype, and no HLA-A68:01 subtype; 2) Tumor KRAS/NRAS G12D mutation is positive; Tumor tissue samples of eligible participants must be collected and sent to a third-party central laboratory for testing, for retrospective analysis; 5. At least one measurable lesion (according to RECIST v1.1); 6. ECOG score of 0-1 and expected survival period greater than 3 months; 7. Sufficient organ function; 8. For women of childbearing age who have not undergone sterilization surgery before menopause, they must agree to use effective contraceptive measures from the start of chemotherapy to one year after the cell infusion, and the serum pregnancy test must be negative within 14 days before the cell infusion; 9. For men who have not undergone sterilization surgery, they must agree to use effective contraceptive measures from the start of chemotherapy until one year after the cell infusion.
Who cannot join
- There are cases where the third interstitial fluid accumulation cannot be controlled clinically and fails to reach a stable state after treatment. According to the investigators' judgment, such participants are not suitable for inclusion in the study.
- Within 4 weeks before reinfusion, the participant has received the last dose of anti-tumor treatment (chemotherapy, endocrine therapy, targeted therapy, immunotherapy, interventional therapy, or traditional Chinese medicine treatment with anti-tumor indications, etc.).
- Within 4 weeks before apheresis, the participant has received live or attenuated live vaccine vaccination.
- The participant has received any gene-engineered T-cell therapy before.
- The participant is known to have an allergic reaction to any component used in the treatment of this study.
- The participant has not recovered to a CTCAE v6.0 grade ≤ 1 level (excluding any level of hair loss, grade ≤ 2 peripheral sensory neuropathy, and toxicity judged by the investigator as safe) from previous surgery or treatment-related adverse reactions.
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- The participant has a history of meningeal metastasis or central nervous system metastasis, or has a clear underlying disease of the central nervous system within 6 months before apheresis and significant symptoms remaining; participants with asymptomatic brain metastasis or those whose symptoms have stabilized after treatment of brain metastasis lesions (such as surgery, radiotherapy) and do not require steroid use can participate in this study.
- Hypertension that is poorly controlled (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg after treatment) or clinically significant cardiovascular diseases (such as cerebrovascular accident within 6 months before signing the principal informed consent form, myocardial infarction within 6 months before signing the principal informed consent form, unstable angina pectoris, congestive heart failure classified as NYHA grade II or above, or severe arrhythmia that cannot be controlled by medication or has potential impact on the study treatment); if the electrocardiogram shows clinically significant abnormalities in 3 consecutive times (each interval of at least 5 minutes) or the average QTcF is ≥ 450 ms.
- Complicated with other serious organic diseases or mental disorders.
- Systemic active infection.
- Known HIV infection (positive anti-HIV antibody), or active hepatitis B (positive HBsAg test, or positive HBcAb test and positive HBV-DNA test), or active hepatitis C (positive anti-HCV antibody test and positive HCV-RNA test), or active syphilis infection.
- Diagnosed with immunodeficiency or autoimmune diseases, and the participant has received or is expected to receive high-dose systemic steroid treatment (prednisone daily dose over 10 mg or equivalent) or any other form of immunosuppressive treatment within 7 days before apheresis or during the period of apheresis to reinfusion.
- Within 2 weeks before apheresis and 2 weeks before reinfusion, plans to use hydroxyurea, immunomodulatory drugs (such as granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), cytarabine, etc.).
- History of organ transplantation, allogeneic stem cell transplantation and renal replacement therapy.
- Known uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease or liver failure.
- Known alcohol and/or drug abusers.
- Pregnant or lactating women.
- Participants with any medical conditions or diseases that the investigator deems may affect the conduct of this study.
- Participants judged by the investigators to be unable to complete all visits or procedures required by the study protocol (including the follow-up period), or have insufficient compliance to participate in this study, or the investigator considers them unsuitable for inclusion.
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
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xianjun Yu, PhD, 021-64175590, yuxianjun@fudanpci.org
Jiangsu Province Hospital
Shanghai, Shanghai Municipality, 210029
Kuirong Jiang, PhD, 025-83714511, Jiangkuirong@163.com
About this study
Official title: A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Clinical Efficacy of DCTY1102 Injection in the Treatment of Participants With Advanced Malignant Tumors Harboring KRAS/NRAS G12D Mutation Positivity and HLA-A*11:01 Genotype
This is a Phase 1/2, open-label, single-arm, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of DCTY1102 Injection in participants with advanced malignant tumors harboring KRAS/NRAS G12D mutations and positive for HLA-A11:01. DCTY1102 Injection is an autologous genetically modified T-cell receptor (TCR) T-cell therapy product targeting the KRAS/NRAS G12D mutant neoantigen presented in the context of HLA-A11:01. Eligible participants will receive lymphodepleting conditioning with fludarabine and cyclophosphamide, followed by a single intravenous infusion of DCTY1102.
The Phase 1 dose-escalation stage will employ a standard 3+3 design with three planned dose levels: 3×10⁹, 6×10⁹, and 9×10⁹ CD8⁺ TCR⁺ T cells (±20%). The primary objectives are to evaluate the safety and tolerability of DCTY1102, determine the maximum tolerated dose (MTD), and identify the recommended Phase 2 dose (RP2D), with a dose-limiting toxicity (DLT) assessment period of 28 days post-infusion. Secondary objectives include characterization of pharmacokinetic (PK) profiles, preliminary assessment of anti-tumor activity, evaluation of pharmacodynamic (PD) changes, and assessment of immunogenicity.
The Phase 2 dose-expansion stage will enroll approximately 12 to 20 participants at the RP2D/MTD to further evaluate the objective response rate (ORR) as the primary efficacy endpoint, as well as long-term safety, extended PK/PD profiling, and immunogenicity.
- Conditions
- Colorectal Cancer, Lung Cancer, Pancreatic Cancer
- Being tested
- TCR-T cells
- Medical subject headings
- Colorectal Neoplasms, Lung Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCR-T cellsBiological
The single infusion of DCTY1102 injection was divided into three dosage levels: 3×10^9 ± 20% cells, 6×10^9 ± 20% cells, and 9×10^9 ± 20% cells. The cell count was calculated based on CD8+ TCR+ T cells.
| Study group | Role | What they receive |
|---|---|---|
| TCR-T treatment group | Experimental | Participants will exposed to Individualized Tumor-t Cell Receptor (TCR) -Mediated T Cells therapy Receives: Biological: TCR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limited Toxicity（DLT），Maximum tolerated dose (MTD) and Recommended Phase II dose (RP2D) of DCTY1102
Measured: 28 days after infusion
Adverse events and Serious adverse events
Incidence of adverse events and serious adverse events by dose level
Measured: up to 24 months post-infusion
Secondary outcomes (1)
Preliminary anti-tumor activity of DCTY1102 in subject with advanced solid tumors
Measured: Up to 24 months post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study startMay 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Biological: TCR-T therapy
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing DCTY Biotech Co.,Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014878
- Sponsor's protocol ID
- DCTY-CT001
- Status last verified
- May 2026
- First submitted
- 14 May 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Clinical Efficacy of DCTY1102 Injection in the Treatment of Participants With Advanced Malignant Tumors Harboring KRAS/NRAS G12D Mutation Positivity and HLA-A*11:01 Genotype
- ClinicalTrials.gov ID
- NCT07014878
- Acronym / sponsor ID
- DCTY-CT001
- Conditions
- Colorectal Cancer, Lung Cancer, Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Beijing DCTY Biotech Co.,Ltd.University, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 11 Jun 2025 (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 1/2, open-label, single-arm, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of DCTY1102 Injection in participants with advanced malignant tumors harboring KRAS/NRAS G12D mutations and positive for HLA-A11:01. DCTY1102 Injection is an autologous genetically modified T-cell receptor (TCR) T-cell therapy product targeting the KRAS/NRAS G12D mutant neoantigen presented in the context of HLA-A11:01. Eligible participants will receive lymphodepleting conditioning with fludarabine and cyclophosphamide, followed by a single intravenous infusion of DCTY1102.
The Phase 1 dose-escalation stage will employ a standard 3+3 design with three planned dose levels: 3×10⁹, 6×10⁹, and 9×10⁹ CD8⁺ TCR⁺ T cells (±20%). The primary objectives are to evaluate the safety and tolerability of DCTY1102, determine the maximum tolerated dose (MTD), and identify the recommended Phase 2 dose (RP2D), with a dose-limiting toxicity (DLT) assessment period of 28 days post-infusion. Secondary objectives include characterization of pharmacokinetic (PK) profiles, preliminary assessment of anti-tumor activity, evaluation of pharmacodynamic (PD) changes, and assessment of immunogenicity.
The Phase 2 dose-expansion stage will enroll approximately 12 to 20 participants at the RP2D/MTD to further evaluate the objective response rate (ORR) as the primary efficacy endpoint, as well as long-term safety, extended PK/PD profiling, and immunogenicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Biological: TCR-T therapy
| Arm | Type | Receives |
|---|---|---|
| TCR-T treatment group | Experimental | Biological: TCR-T cellsParticipants will exposed to Individualized Tumor-t Cell Receptor (TCR) -Mediated T Cells therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Before conducting any research-related operations, an informed consent form (ICF) must be signed;
- Age should be between 18 and 70 years old;
- Participants with advanced malignant tumors (including but not limited to pancreatic cancer, colorectal cancer, lung cancer, etc.) diagnosed by histological or cytological methods, who have failed standard treatment (disease progression after treatment) or have treatment intolerance;
- Must meet the following two criteria simultaneously:
- 1) HLA-A11:01 genotype, and no HLA-A68:01 subtype; 2) Tumor KRAS/NRAS G12D mutation is positive; Tumor tissue samples of eligible participants must be collected and sent to a third-party central laboratory for testing, for retrospective analysis; 5. At least one measurable lesion (according to RECIST v1.1); 6. ECOG score of 0-1 and expected survival period greater than 3 months; 7. Sufficient organ function; 8. For women of childbearing age who have not undergone sterilization surgery before menopause, they must agree to use effective contraceptive measures from the start of chemotherapy to one year after the cell infusion, and the serum pregnancy test must be negative within 14 days before the cell infusion; 9. For men who have not undergone sterilization surgery, they must agree to use effective contraceptive measures from the start of chemotherapy until one year after the cell infusion.
Key exclusion criteria (19 listed)
- There are cases where the third interstitial fluid accumulation cannot be controlled clinically and fails to reach a stable state after treatment. According to the investigators' judgment, such participants are not suitable for inclusion in the study.
- Within 4 weeks before reinfusion, the participant has received the last dose of anti-tumor treatment (chemotherapy, endocrine therapy, targeted therapy, immunotherapy, interventional therapy, or traditional Chinese medicine treatment with anti-tumor indications, etc.).
- Within 4 weeks before apheresis, the participant has received live or attenuated live vaccine vaccination.
- The participant has received any gene-engineered T-cell therapy before.
- The participant is known to have an allergic reaction to any component used in the treatment of this study.
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 |
|---|---|---|
| TCR-T cellsThe single infusion of DCTY1102 injection was divided into three dosage levels: 3×10^9 ± 20% cells, 6×10^9 ± 20% cells, and 9×10^9 ± 20% cells. The cell count was calculated based on CD8+ TCR+ T cells. | Biological | TCR-T treatment group |
Primary outcome
Dose Limited Toxicity（DLT），Maximum tolerated dose (MTD) and Recommended Phase II dose (RP2D) of DCTY1102
Time frame: 28 days after infusion
Adverse events and Serious adverse events
Time frame: up to 24 months post-infusion
Incidence of adverse events and serious adverse events by dose level
1 secondary outcome
Preliminary anti-tumor activity of DCTY1102 in subject with advanced solid tumors
Time frame: Up to 24 months post-infusion
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 May 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 TCR-T cells in people with Colorectal Cancer and Lung Cancer, run by Beijing DCTY Biotech 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 5 inclusion and 19 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 18 May 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 Xianjun Yu, PhD (021-64175590, yuxianjun@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limited Toxicity（DLT），Maximum tolerated dose (MTD) and Recommended Phase II dose (RP2D) of DCTY1102 (time frame: 28 days after infusion). 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 May 2026.