This is an open-label, multicenter, Phase I/II study designed to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of EMB-07 combination therapy in adult patients with aggressive B-cell non-Hodgkin lymphoma (B-NHL). The study consists two phases: Phase I of dose escalation and Phase II of dose expansion. Approximately 115 patients will be enrolled in this study (i.e., 5 cohorts of approximately 23 patients per cohort). Multiple EMB-07-based combination regimens will be evaluated in patients with relapsed/refractory (R/R) aggressive B-NHL (Cohort A) and patients with newly diagnosed aggressive B-NHL (Cohort B).
Ability to understand and voluntarily sign the Informed Consent Form (ICF);
Patients aged ≥18 years;
Life expectancy > 12 weeks;
ECOG performance status score: ≤1 point during the dose escalation phase, ≤2 points during the dose expansion phase.
Current or prior central nervous system (CNS) or meningeal involvement related to the underlying disease.
Cohort A: Prior exposure to any ROR1-targeted agent (e.g., biologic or CAR-T); or Cohort A1: Prior exposure to Gemcitabine-based chemotherapy (≥ 2 consecutive cycles); or Cohort A2: Prior exposure to Polatuzumab Vedotin; or Cohorts A3 and A4: Refractory to prior Lenalidomide/Zanubrutinib or Chidamide therapy, respectively.
Contraindications to any agent included in the combination therapy regimen.
Cohort A: Candidates suitable for ASCT or CAR-T cell therapy.