MedTrace Logo

A Study of DCTY1102 Injection in Participants With Advanced Solid Tumors

NCT07014878 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-05-18

No results posted yet for this study

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

Interventions

BIOLOGICAL

TCR-T cells

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.

Sponsors & Collaborators

  • Beijing DCTY Biotech Co.,Ltd.

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-08-31
Completion
2028-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07014878 on ClinicalTrials.gov