A Study of DCTY1102 Injection in Participants With Advanced Solid Tumors

NCT07014878 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: DCTY-CT001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief 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. 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

Lung Cancer; Pancreatic Cancer; Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• Dose Limited Toxicity（DLT），Maximum tolerated dose (MTD) and Recommended Phase II dose (RP2D) of DCTY1102

  28 days after infusion

• Adverse events and Serious adverse events

  Incidence of adverse events and serious adverse events by dose level

  up to 24 months post-infusion

Secondary Outcomes (1)

• Preliminary anti-tumor activity of DCTY1102 in subject with advanced solid tumors

  Up to 24 months post-infusion

Study Arms (1)

TCR-T treatment group

EXPERIMENTAL

Participants will exposed to Individualized Tumor-t Cell Receptor (TCR) -Mediated T Cells therapy

Biological: TCR-T cells

Interventions

TCR-T cells BIOLOGICAL

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.

TCR-T treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \) HLA-A\*11:01 genotype, and no HLA-A\*68:01 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Beijing DCTY Biotech Co.,Ltd.: lead

Study Sites (2)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Jiangsu Province Hospital

Shanghai, Shanghai Municipality, 210029, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Lung Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Xianjun Yu, PhD

CONTACT

021-64175590; yuxianjun@fudanpci.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Biological: TCR-T therapy

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: June 11, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)