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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

ConditionsCombination TherapyAggressive B-Cell Non-Hodgkin LymphomaEMB07phaseI/II
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai EpimAb Biotherapeutics Co., Ltd.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

115 Participants
are divided into 1 treatment group
Group A: Phase I: Dose Escalation, Phase II: Dose ExpansionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Up to 28 days
2

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

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

Time frame
From enrollment up to 30 days after the last dose
3

Recommended phase II dose (RP2D) of EMB-07

Time frame
Up to 28 days
4

Objective Response Rate (ORR)

Objective response rate, measured by Lugano 2014

Time frame
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

1

Duration of Response (DOR)

Time from first study drug dose to first documented disease progression (per Lugano 2014 criteria) or death from any cause, whichever occurs first.

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

Duration of Complete Response（DOCR）

Time from first study drug dose to first documented disease progression (per Lugano 2014 criteria) or death from any cause, whichever occurs first.

Time frame
From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years
3

Time to Treatment Response（TTR）

Time from first study drug dose to first documented disease progression (per Lugano 2014 criteria) or death from any cause, whichever occurs first.

Time frame
From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years
4

Time to Complete Response（TTCR）

Time from first study drug dose to first documented disease progression (per Lugano 2014 criteria) or death from any cause, whichever occurs first.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai EpimAb Biotherapeutics Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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