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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. 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.