A Phase I/II Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of the EMB-07 C… (NCT07432022) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Phase I/II Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of the EMB-07 Combination Therapy in Patients With Aggressive B-Cell Non-Hodgkin Lymphoma
115 participantsStarted 2026-03-01
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Cohort A: Pathologically confirmed aggressive R/R B-NHL, including DLBCL, not otherwise specified (NOS), or DLBCL transformed from indolent lymphoma (e.g., follicular lymphoma) (t-DLBCL), or other aggressive B-NHL judged to potentially benefit from study treatment by the investigator and sponsor (e.g., high-grade B-cell lymphoma \[HGBL\], Richter transformation, other large B-cell lymphoma subtypes).
Exclusion criteria
✕. 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.
What they're measuring
1
Maximum tolerated dose (MTD) of EMB-07（Phase I only）
Timeframe: Up to 28 days
2
Rate of Adverse Events (AE) and Serious Adverse Events (SAE)
Timeframe: From enrollment up to 30 days after the last dose
3
Recommended phase II dose (RP2D) of EMB-07
Timeframe: Up to 28 days
4
Objective Response Rate (ORR)
Timeframe: From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
✕. Contraindications to any agent included in the combination therapy regimen.
✕. Cohort A: Candidates suitable for ASCT or CAR-T cell therapy.
✕. Cohort A: Use of any standard or investigational therapy for the underlying disease within 28 days before C1D1 or 5 half-lives (whichever is shorter), including chemotherapy, immunotherapy, radioimmunotherapy, non-palliative radiotherapy, or any other anti-tumor therapy. Only palliative radiotherapy to non-target lesions will be permitted.
✕. Cohort B: B-NHL with prior receipt of at least 2 consecutive cycles of R-CHOP (prior lymph node biopsy or local radiotherapy will not be an exclusion criterion).
✕. Major surgery or live vaccine administration within 28 days prior to C1D1.
✕. History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation (except corneal transplantation). In addition, patients who received ASCT within 3 months before C1D1, CAR-T within 6 months before C1D1, or diagnosed with graft-versus-host disease (GVHD) will be excluded.