Excyte pushes YK012 lymphoma trial completion date back 18 months to 2028

The change

The registry record for NCT06565689 shows the primary completion date moved from June 30, 2026 to December 1, 2028, a shift the trial's own change history logs as a single amendment made on July 17, 2026. The trial's enrollment target stayed at 48 patients through the change, and the operational model's enrollment-jump check reads the move as typical for a Phase 1 design, since it flags shifts only at 20% or more and this trial recorded none. That combination, a completion date that moves without an accompanying enrollment change, points to a revised internal timeline for the study rather than a recruitment problem. NCT06565689A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of YK012NCT06565689

Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.

Endpoint Met24%

Completes82%

Clinical Significance4%

Regulatory47%

What the trial tests

YK012 is being dosed intravenously in a single-arm, open-label Phase 1 study that enrolls adults with relapsed or refractory B-cell non-Hodgkin lymphoma who have already received rituximab and at least a second line of therapy. The three primary endpoints are the incidence of adverse events and serious adverse events, the incidence and profile of dose-limiting toxicities observed in the 28 days after the first dose, and the maximum tolerated dose or recommended dose for further study, defined as the highest dose at which one in six or fewer patients experiences a dose-limiting toxicity. Secondary measures include progression-free survival, duration of response, and objective response rate at 24 weeks, alongside standard pharmacokinetic and immunogenicity assessments. No results have posted on the trial's ClinicalTrials.gov record to date. NCT06565689A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of YK012NCT06565689

The landscape

YK012's molecular target and mechanism of action are not established in the available registry data, so no claim of novelty or first-in-class status attaches to the program. The trials sharing the same indication in the broader B-cell non-Hodgkin lymphoma field span a mechanistically diverse set, including checkpoint inhibitors such as Bristol-Myers Squibb's nivolumab and Merck's pembrolizumab, an antibody-drug conjugate in Takeda's brentuximab vedotin, and CD19-directed cell therapies, none of which share YK012's mechanism and none of which are eligible comparators to this trial. Two bendamustine-based products carry FDA approval specifically for indolent B-cell non-Hodgkin lymphoma that has progressed after rituximab, the same relapsed setting this trial enrolls. Against that backdrop, YK012's Phase 1 dataset will add a first read on an uncharacterized mechanism rather than test against an established standard. NCT06565689A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of YK012NCT06565689

Sponsor context

Excyte Biopharma Ltd runs seven trials across its pipeline, five recruiting and two not yet recruiting, and YK012 is the company's only asset in B-cell non-Hodgkin lymphoma on record. The trial has logged one primary-completion-date change since it started enrolling in May 2023, and its registry-churn profile reads as stable, with one amendment recorded over roughly a year and a half of activity. NCT06565689A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of YK012NCT06565689

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.