Trials / Not Yet Recruiting
Not Yet RecruitingNCT07432022
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
A Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EMB-07 (a Bispecific Antibody Targeting CD3 and Receptor-tyrosine-kinase-like Orphan Receptor 1 [ROR1]) Combination Therapy in Patients With Aggressive B-cell Non-Hodgkin Lymphoma
- Status
- Not Yet Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 115 (estimated)
- Sponsor
- Shanghai EpimAb Biotherapeutics Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | EMB07 | EMB-07 is a bispecific antibody targeting CD3 and receptor-tyrosine-kinase-like orphan receptor 1 \[ROR1\] |
| DRUG | Rituximab/Gemcitabine/Oxaliplatin | 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. |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2028-06-30
- Completion
- 2028-06-30
- First posted
- 2026-02-25
- Last updated
- 2026-02-25
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07432022. Inclusion in this directory is not an endorsement.