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Monoclonal Antibodies

Magrolimab + Mogamulizumab for T-Cell Lymphoma

Phase 1 & 2

Waitlist Available

Led By Michael S Khodadoust

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

ECOG performance status =< 2 (Karnofsky >= 60%)

Must not have

Patients with RBC transfusion dependence, defined as requiring more than 2 units of RBCs transfused during the 4-week period prior to screening

Prior progression of disease with mogamulizumab

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing magrolimab in combination with mogamulizumab to see if it can help patients with T-cell lymphoma that has come back or does not respond to treatment. Magrolimab and mogamulizumab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread.

Who is the study for?

Adults with stage IB-IV mycosis fungoides or Sezary syndrome T-cell lymphoma that's relapsed or refractory, who've had prior systemic therapy and meet specific health criteria (like certain blood cell counts and organ function). Not for those pregnant/nursing, with certain allergies, recent heart issues, uncontrolled illnesses, active brain metastases, or on conflicting treatments.

What is being tested?

The trial is testing the combination of two monoclonal antibodies: Magrolimab and Mogamulizumab. It aims to find the best dose and observe benefits/side effects in patients whose cancer has returned or isn't responding to treatment. The goal is to see if this combo can better stabilize cancer than current treatments.

What are the potential side effects?

Potential side effects include reactions related to the immune system such as inflammation in various organs due to antibody activity. Other common side effects might be fatigue, infusion-related reactions like fever or chills, possible digestive disturbances including nausea or diarrhea.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself but might not be able to do heavy physical work.

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I can take care of myself but may not be able to do active work.

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I am HIV-positive, on treatment, and my viral load is undetectable.

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My hepatitis B is under control with treatment.

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My hemoglobin level is at least 9.5 g/dL and I don't need blood transfusions.

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I had hepatitis C but am cured, or I'm being treated with no detectable virus.

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I agree to use birth control during and 4 months after the trial.

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I am 18 years or older and interested in a trial for a new cancer treatment.

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I have been diagnosed with mycosis fungoides or Sezary syndrome, stages IB-IV, without large cell transformation currently.

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I am 18 years old or older.

Exclusion Criteria

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

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I needed more than 2 blood transfusions in the last month.

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My condition worsened after treatment with mogamulizumab.

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I have not had a heart attack or severe heart failure in the last 6 months.

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I do not have new or worsening brain metastases or leptomeningeal disease.

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I am not taking immunotherapy, immunosuppressants, certain herbal remedies, growth factors, or live vaccines.

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I have not needed treatment for autoimmune blood disorders in the last year.

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I had a stem cell transplant and have had graft-versus-host disease or needed immunosuppression in the last 3 months.

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I have not been treated with magrolimab or drugs targeting CD47-SIRPalpha.

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I have had allergic reactions to certain medications similar to magrolimab.

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I currently have an active herpes infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Overall response rate at 6 months (ORR6) (Phase II)

Secondary study objectives

Duration of response (DOR)

Overall response rate (ORR)

Overall response rate at 12 months (ORR12)

+3 more

Side effects data

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

67%

Abdominal pain

33%

Infusion related reaction

33%

Performance status decreased

33%

Pyrexia

33%

Pain

33%

Gait disturbance

33%

Hypotension

33%

Hyperhidrosis

33%

Malignant neoplasm progression

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

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (magrolimab, mogamulizumab), Phase Ib and Phase IIExperimental Treatment6 Interventions

Patients receive magrolimab IV over 2-3 hours weekly during cycles 1-2, then Q2W during cycles 3-12. Patients also receive mogamulizumab IV over at least 60 minutes weekly during cycle 1, then Q2W during cycles 2-12. Cycles repeat every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT or diagnostic CT, blood sample collection, and may undergo a skin punch biopsy during screening and on study.

Group II: Arm II (mogamulizumab), Phase IIActive Control6 Interventions

Patients receive mogamulizumab IV over at least 60 minutes weekly during cycle 1, then Q2W during cycles 2-12. Cycles repeat every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients who have received at least 2 full treatment cycles and have PD or have received at least 6 full treatment cycles and have SD may crossover to Arm I. Patients undergo PET/CT or diagnostic CT, blood sample collection, and may undergo a skin punch biopsy during screening and on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2011

Completed Phase 2

~2200

Computed Tomography

2017

Completed Phase 2

~2790