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

Sponsor
Shanghai EpimAb Biotherapeutics Co., Ltd.
Study ID
NCT07432022
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EMB07 — DRUG
    EMB-07 is a bispecific antibody targeting CD3 and receptor-tyrosine-kinase-like orphan receptor 1 \[ROR1\]
  • 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.

Study Details

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).

Key Dates

Start date
Mar 1, 2026
Status verified
Feb 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
115 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I: Dose Escalation, Phase II: Dose Expansion
    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.

Primary Outcome Measure

Maximum tolerated dose (MTD) of EMB-07（Phase I only） [ Time Frame: Up to 28 days ]

Central Contacts

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