Clinical trial

A Phase 1b/2 Trial of Hu5F9-G4 in Combination With Rituximab or Rituximab + Chemotherapy in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

Name

5F9003

Description

The primary objectives of this study are: * To investigate the safety and tolerability, and to define the recommended Phase 2 dose and schedule (RP2DS) for magrolimab in combination with rituximab and for magrolimab in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx). * To evaluate the efficacy of magrolimab in combination with rituximab in participants with indolent lymphoma and diffuse large B-cell lymphoma (DLBCL) and to evaluate the efficacy of magrolimab in combination with R-GemOx in autologous stem cell transplant (ASCT) ineligible DLBCL participants.

Trial arms

Trial start

2016-11-21

Estimated PCD

2024-05-01

Trial end

2024-05-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Magrolimab

Administered intravenously

Arms:

Magrolimab + R-GemOx, Phase 1b Dose Expansion Phase, Magrolimab + R-GemOx, Phase 1b Safety Dose Escalation Phase, Magrolimab + Rituximab, Phase 1b Dose Escalation, Magrolimab + Rituximab, Phase 2 Diffuse Large B-Cell lymphoma, Magrolimab + Rituximab, Phase 2 Indolent Lymphoma

Other names:

Hu5F9-G4

Rituximab

Administered intravenously on Days 8, 15, and 22 during Cycle 1, followed by 1 dose on Day 1 for Cycles 2 through 6, and Day 1 for every other cycle until Cycle 13

Arms:

Other names:

RITUXAN®, MabThera

Gemcitabine

Administered intravenously on Days 11, 23 for Cycle 1 and Days 2 and 15 for Cycles 2 to 4

Arms:

Magrolimab + R-GemOx, Phase 1b Dose Expansion Phase, Magrolimab + R-GemOx, Phase 1b Safety Dose Escalation Phase

Other names:

Gemzar®

Oxaliplatin

Administered intravenously on Days 11, 23 for Cycle 1 and Days 2 and 15 for Cycles 2 to 4

Arms:

Magrolimab + R-GemOx, Phase 1b Dose Expansion Phase, Magrolimab + R-GemOx, Phase 1b Safety Dose Escalation Phase

Other names:

Eloxatin®

Size

178

Primary endpoint

Phase 1b: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs)

Up to 28 days

Percentage of Participants Experiencing Treatment Emergent Adverse Events

First dose date up to 5 years

Objective Response Rate as Defined by the Investigator According to the Lugano Classification for Lymphomas

Up to 5 months

Eligibility criteria

Key Inclusion Criteria: * Phase 1b only: B-cell non-Hodgkin's lymphoma (NHL), relapsed or refractory to standard approved therapies * DLBCL Phase 2 cohort: De novo or transformed diffuse large B-cell lymphoma (DLBCL) expressing CD 20, relapsed or refractory to at least 2 prior lines treatment containing anti-CD20 therapy * Indolent lymphoma Phase 2 cohort: Marginal zone or follicular lymphoma, relapsed or refractory to standard approved therapies * DLBCL chemotherapy combination cohort: De novo or transformed diffuse large B-cell lymphoma (DLBCL), relapsed or refractory to 1-3 prior lines of treatment * Adequate performance status and hematological, liver and kidney functions * Willing to consent to 1 mandatory pre-treatment and 1 on-treatment tumor biopsy Key Exclusion Criteria: * Active brain metastases * Prior allogeneic hematopoietic cell transplantation * Prior treatment with CD47 or signal regulatory protein alpha (SIRPα) targeting agents * Second malignancy within the last 3 years * Known active or chronic hepatitis B or C infection or HIV * Pregnancy or active breastfeeding * Prior chimeric antigen receptor (CAR-T) therapy Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 178, 'type': 'ACTUAL'}}

Updated at

2023-12-19

1 organization

4 products

1 indication

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Indication

Product

Product

Organization

Product