A Study of DCTY1102 Injection in Participants With Advanced Solid Tumors

Sponsor
Beijing DCTY Biotech Co.,Ltd.
Study ID
NCT07014878
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jun 11, 2025
Start date
May 31, 2026
Status verified
May 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TCR-T treatment group
    Participants will exposed to Individualized Tumor-t Cell Receptor (TCR) -Mediated T Cells therapy

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 ]

Central Contacts

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