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NOT YET RECRUITING
NCT07014878
PHASE1

A Study of DCTY1102 Injection in Participants With Advanced Solid Tumors

Sponsor: Beijing DCTY Biotech Co.,Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2026-05

Completion Date

2028-08

Last Updated

2026-05-18

Healthy Volunteers

No

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.

Locations (2)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Jiangsu Province Hospital

Shanghai, Shanghai Municipality, China