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Monoclonal Antibodies

Magrolimab + Rituximab/Chemotherapy for Non-Hodgkin's Lymphoma

Phase 1 & 2

Waitlist Available

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Phase 1b only: B-cell non-Hodgkin's lymphoma (NHL), 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

Must not have

Second malignancy within the last 3 years

Known active or chronic hepatitis B or C infection or HIV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of magrolimab, in combination with other drugs, for the treatment of lymphoma. The trial will also help to determine the best dose and schedule of magrolimab for future studies.

Who is the study for?

This trial is for adults with B-cell non-Hodgkin's lymphoma that has come back or didn't respond to standard treatments. Participants must have tried at least two prior therapies including anti-CD20 therapy and be willing to undergo tumor biopsies before and during treatment.

What is being tested?

The study tests Magrolimab in combination with Rituximab, or together with Rituximab plus chemotherapy drugs Gemcitabine and Oxaliplatin. It aims to find a safe dose, assess how well the combinations work for different types of this lymphoma, and if they're suitable for patients ineligible for stem cell transplant.

What are the potential side effects?

Potential side effects may include immune reactions due to Magrolimab, infusion-related symptoms from Rituximab, as well as nausea, low blood counts, fatigue from chemotherapy agents like Gemcitabine and Oxaliplatin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My B-cell non-Hodgkin's lymphoma has not responded to standard treatments.

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My DLBCL has not responded to 1-3 previous treatments.

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My DLBCL has not responded to at least 2 prior treatments including anti-CD20 therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had another type of cancer in the last 3 years.

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I have an active or chronic hepatitis B or C infection, or I am HIV positive.

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I have previously received CAR-T therapy.

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I have active cancer spread to my brain.

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I have had a stem cell transplant from a donor.

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I have not been treated with CD47 or SIRPα targeting agents before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Lymphoma

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

Secondary study objectives

Duration of Response

Objective Rate of Response Defined by the Investigator According to the LYRIC Criteria for Lymphomas

Overall Survival

+8 more

Side effects data

From 2020 Phase 1 & 2 trial • 78 Patients • NCT02953782

67%

Abdominal pain

33%

Malignant neoplasm progression

33%

Infusion related reaction

33%

Performance status decreased

33%

Pyrexia

33%

Pain

33%

Gait disturbance

33%

Hypotension

33%

Hyperhidrosis

33%

Gastrooesophageal reflux disease

33%

Headache

33%

Deafness

33%

Vomiting

33%

Pollakiuria

33%

Diarrhoea

33%

Rash maculo-papular

33%

Lactic acidosis

33%

Nausea

33%

Aspartate aminotransferase increased

33%

Blood alkaline phosphatase increased

33%

Blood bilirubin increased

33%

Blood lactate dehydrogenase increased

33%

Mental disorder

33%

Constipation

100%

80%

60%

40%

20%

Study treatment Arm

Magrolimab Priming Dose Only

Magrolimab 45 mg/kg

Magrolimab 10 mg/kg

Magrolimab 20 mg/kg

Magrolimab 30 mg/kg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Magrolimab + Rituximab, Phase 2 Indolent LymphomaExperimental Treatment2 Interventions

Participants with indolent lymphoma will receive magrolimab based on RP2DS from Phase 1b portion of the study in combination with rituxumab 375 mg/m\^2.

Group II: Magrolimab + Rituximab, Phase 2 Diffuse Large B-Cell lymphomaExperimental Treatment2 Interventions

Participants with diffuse large B-cell lymphoma (DLBCL) will receive magrolimab based on RP2DS from Phase 1b portion of the study in combination with rituxumab 375 mg/m\^2.

Group III: Magrolimab + Rituximab, Phase 1b Dose EscalationExperimental Treatment2 Interventions

Participants with B-cell non-Hodgkin's lymphoma will receive 1 mg/kg magrolimab priming dose on Day 1 of Cycle 1 followed by weekly maintenance doses of 10, 20, 30, or 45 mg/kg on Days 8, 15, 22 for Cycle 1 and Days 1, 8, 15, and 22 for each cycle to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose and schedule (RP2DS) in combination with rituxumab 375 mg/m\^2. Cycle length is 28 days.

Group IV: Magrolimab + R-GemOx, Phase 1b Safety Dose Escalation PhaseExperimental Treatment4 Interventions

Autologous stem cell transplant (or transplantation) ineligible DLBCL participants will receive 1 mg/kg magrolimab priming dose on Day 1 for Cyle 1 followed by maintenance doses of 30 or 45 mg/kg on Days 8, 11, 15, 22, and 29 for Cycle 1, every week for Cycle 2, and every 2 weeks for each cycle to determine maximum tolerated dose (MTD) + rituxumab 375 mg/m\^2 + gemcitabine 1000 mg/m\^2 + oxaliplatin 100 mg/m\^2. Cycle length is 28 days.

Group V: Magrolimab + R-GemOx, Phase 1b Dose Expansion PhaseExperimental Treatment4 Interventions

Autologous stem cell transplant (or transplantation) ineligible DLBCL participants will receive magrolimab at a dose determined from Phase 1b Safety Dose-Escalation Phase in combination with rituxumab 375 mg/m\^2 + gemcitabine 1000 mg/m\^2 + oxaliplatin 100 mg/m\^2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magrolimab

2022

Completed Phase 2

~220

Rituximab

1999

Completed Phase 4

~2990