RecruitingPhase 1NCT06565689

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of YK012

A Multi-center, Open-Label, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of YK012 in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma


Sponsor

Excyte Biopharma Ltd

Enrollment

48 participants

Start Date

May 9, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to provide a basis for further clinical development of YK012.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new drug called STX-123 (or similar) in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) — a group of blood cancers — to evaluate safety, dosing, and early signs of effectiveness. **You may be eligible if...** - You are age 18–65 with a confirmed diagnosis of relapsed or refractory B-NHL (including follicular lymphoma, DLBCL, mantle cell lymphoma, MALT lymphoma, Burkitt lymphoma, or others) - You have received prior treatment including rituximab and at least one second-line therapy - You have at least one measurable tumor on imaging - You are in good general health (ECOG ≤1) and have adequate blood, liver, and kidney function **You may NOT be eligible if...** - You have active central nervous system lymphoma - You have had a prior stem cell transplant (allogeneic) or CAR-T cell therapy in certain timeframes - You are pregnant or breastfeeding - You have significant ongoing side effects from prior treatment - You have active, uncontrolled infection including HIV or hepatitis B/C Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGYK012

YK012 is a bispecific antibody targeting CD19 on B cells and CD3 on T cells leading to T cell-mediated cytotoxicity of malignant B cells


Locations(1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

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NCT06565689


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