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

NCT07432022 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: EMB07X102
• Study Type: interventional
• Target: 115
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Combination Therapy; Aggressive B-Cell Non-Hodgkin Lymphoma; EMB07; phaseI/II

Outcome Measures

Primary Outcomes (4)

• Maximum tolerated dose (MTD) of EMB-07（Phase I only）

  Up to 28 days

• Rate of Adverse Events (AE) and Serious Adverse Events (SAE)

  Adverse events and serious adverse events as assessed by CTCAE v5.0

  From enrollment up to 30 days after the last dose

• Recommended phase II dose (RP2D) of EMB-07

  Up to 28 days

• Objective Response Rate (ORR)

  Objective response rate, measured by Lugano 2014

  From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years

Secondary Outcomes (11)

• Duration of Response (DOR)

  From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years

• Duration of Complete Response（DOCR）

  From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years

• Time to Treatment Response（TTR）

  From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years

• Time to Complete Response（TTCR）

  From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years

• Event-Free Survival（EFS）

  From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years

Study Arms (1)

Phase I: Dose Escalation, Phase II: Dose Expansion

EXPERIMENTAL

Phase I: Dose Escalation During the dose escalation, the planned starting dose of EMB-07 is 6 mg. A dose escalation scheme of "3+3" will be followed to determine DLT, MTD, and RP2CD. Phase II: Dose Expansion For each cohort: During the dose-expansion, approximately 10 to 15 patients will be enrolled and administrated in each cohort to further characterize the safety profile and anti-tumor activity of the combination therapies. Approximately 20 patients per cohort receiving RP2CD will be pooled from the dose escalation and dose expansion phases to evaluate preliminary efficacy signals.

Drug: EMB07; Drug: Rituximab/Gemcitabine/Oxaliplatin

Interventions

EMB07 DRUG

EMB-07 is a bispecific antibody targeting CD3 and receptor-tyrosine-kinase-like orphan receptor 1 \[ROR1\]

Phase I: Dose Escalation, Phase II: Dose Expansion

Rituximab/Gemcitabine/Oxaliplatin DRUG

Rituximab is a monoclonal antibody drug specifically targeting the CD20 antigen. Gemcitabine is a chemotherapy drug classified as an antimetabolite. Oxaliplatin is a platinum-based chemotherapy drug.

Phase I: Dose Escalation, Phase II: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Cohort B: Newly diagnosed, treatment-naïve DLBCL NOS confirmed by pathology, or t-DLBCL not previously treated with adequate (at least 2 cycles) R-CHOP therapy (excluding Richter transformation or HGBL with BCL2/MYC±BCL6 rearrangements). Patients with newly diagnosed DLBCL NOS should have an International Prognostic Index (IPI) score ≥2 and Ann Arbor stage ≥2. The sponsor will reserve the right to limit the number of t-DLBCL patients enrolled in the study. Other aggressive B-NHLs patients who may benefit from the study treatment can be enrolled after careful risk/benefit assessment by the sponsor and investigator.

You may not qualify if:

• 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.
• 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.
• Any AE related to prior therapy (excluding alopecia) that has not resolved to Grade ≤ 1 (per the Common Terminology Criteria for Adverse Events \[CTCAE\], Version 5.0) or baseline at C1D1.
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening. Patients with positive HBsAg and/or positive HBcAb but negative HBV DNA will be eligible for enrollment. Patients with positive HCV antibody but negative HCV RNA are also eligible for enrollment.
• Known positive HIV serology or history of active viral infection
• Active infection requiring parenteral antibiotics, antivirals, or antifungals within 14 days before C1D1; prophylactic use of these agents (including parenteral administration) will be permitted.
• Prior malignancy requiring treatment or with evidence of recurrence within 5 years before C1D1 (except non-melanoma skin cancer or adequately treated carcinoma in situ of the cervix). Patients with a history of cancer treated with curative intent \> 5 years before C1D1 and no evidence of recurrence will be eligible.
• Ischemic or hemorrhagic stroke of Grade ≥ 3, or gastrointestinal bleeding of Grade ≥ 3, within 6 months before C1D1.
• Active, unstable cardiovascular function:
• Myocardial infarction within 6 months before C1D1;

Sponsors & Collaborators

• Shanghai EpimAb Biotherapeutics Co., Ltd.: lead

MeSH Terms

Interventions

Rituximab; gemcitabine-oxaliplatin regimen

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Xikang Xu

CONTACT

86-21-61951000; xkxu@epimab.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 25, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 25, 2026

Record last verified: 2026-02