← Back to Search

Monoclonal Antibodies

Magrolimab for Mycosis Fungoides and Sezary Syndrome

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%)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

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

Select...

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

Select...

My hepatitis B is under control with treatment.

Select...

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

Select...

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

Select...

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

Select...

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

Select...

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

Select...

I am 18 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Recommended phase 2 dose (RP2D) of magrolimab when given in combination with mogamulizumab (Phase Ib)

Secondary outcome measures

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%

Dry skin

44%

Diarrhoea

44%

Dermatitis acneiform

44%

Fatigue

44%

Lymphocyte count decreased

33%

Infusion related reaction

33%

Abdominal pain

22%

Myalgia

22%

Decreased appetite

22%

Small intestinal obstruction

22%

Tinnitus

22%

Nausea

22%

Chills

22%

Oedema peripheral

22%

Back pain

22%

Headache

22%

Pruritus

22%

Dehydration

22%

Rash maculo-papular

11%

Hypokalaemia

11%

Dyspepsia

11%

Tumour pain

11%

Hypertension

11%

Dyspnoea

11%

Lymphopenia

11%

Malignant neoplasm progression

11%

Cerebrovascular accident

11%

Anaemia

11%

Palpitations

11%

Conjunctivitis allergic

11%

Dry eye

11%

Abdominal distension

11%

Constipation

11%

Gastrooesophageal reflux disease

11%

Hypoaesthesia oral

11%

Folliculitis

11%

Sinusitis

11%

Gastrointestinal stoma complication

11%

Aspartate aminotransferase increased

11%

Blood bilirubin increased

11%

Hypomagnesaemia

11%

Hypophosphataemia

11%

Dizziness

11%

Confusional state

11%

Depression

11%

Haematuria

11%

Dysphonia

11%

Ingrowing nail

11%

Skin infection

11%

Tinea cruris

11%

Platelet count decreased

11%

Alanine aminotransferase increased

11%

Photopsia

11%

Conjunctivitis

11%

Gastroenteritis viral

11%

Hyperglycaemia

11%

Arthralgia

11%

Neck pain

11%

Somnolence

11%

Nasal congestion

11%

Deep vein thrombosis

11%

Oesophageal pain

11%

Vomiting

11%

Chest discomfort

100%

80%

60%

40%

20%

Study treatment Arm

Magrolimab 10 mg/kg

Magrolimab 20 mg/kg

Magrolimab 30 mg/kg

Magrolimab 45 mg/kg

Magrolimab Priming Dose Only

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

Computed Tomography

2017

Completed Phase 2

~2720

Positron Emission Tomography

2008

Completed Phase 2

~2240

Punch Biopsy

2017

N/A

~40

Biospecimen Collection

2004

Completed Phase 2

~1730

Magrolimab

2021

Completed Phase 2

~170

Mogamulizumab

2016

Completed Phase 2

~70

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,657 Previous Clinical Trials

40,933,579 Total Patients Enrolled

Michael S KhodadoustPrincipal InvestigatorCity of Hope Comprehensive Cancer Center LAO

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What objectives do investigators hope to meet with this experiment?

"This trial will evaluate the primary outcome of Overall Response Rate at 6 months (ORR6) over a period spanning 4 weeks from receiving the initial magrolimab infusion. Secondary outcomes include ORR12, defined by patients having a partial or complete response for 12+ months; ORR, marked by global response score; and PFS observed through Kaplan-Meier method and log-rank test."

Answered by AI

What is the upper limit of participants involved in this research?

"Yes, the information provided on clinicaltrials.gov confirms that recruitment for this trial is still underway. Initially posted in December 2020 and last updated in November 2022, it requires 88 participants to be recruited at two separate sites."

Answered by AI

Are there other precedents for Magrolimab's efficacy in clinical testing?

"Magrolimab was first studied in 2013 at Aichi Medical University, with 80 concluded trials and 25 presently active ones. Most of these current studies are being conducted from a medical facility located in Duarte, California."

Answered by AI

Is enrollment open for this investigational study?

"According to clinicaltrials.gov, the recruitment process for this medical study is ongoing; it was initially published on December 24th 2020 and last updated on November 10th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing the Addition of an Anti-cancer Drug, Hu5F9-G4 (Magrolimab), to the Usual Chemotherapy Treatment (Mogamulizumab) in T-Cell (a Type of Immune Cell) Lymphoma That Has Returned After Treatment or Does Not Respond to Treatment

2021. "Testing the Addition of an Anti-cancer Drug, Hu5F9-G4 (Magrolimab), to the Usual Chemotherapy Treatment (Mogamulizumab) in T-Cell (a Type of Immune Cell) Lymphoma That Has Returned After Treatment or Does Not Respond to Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04541017.

All > Mycosis Fungoides