Study Stopped
Drug supply issues
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
A Phase 1b/2 Study of Hu5F9-G4 (Magrolimab) in Combination With Mogamulizumab in Relapsed/Refractory Treated T-Cell Lymphoma
4 other identifiers
interventional
8
1 country
18
Brief Summary
This phase Ib/II trial identifies the best dose and possible benefits and/or side effects of magrolimab when given in combination with mogamulizumab in treating patients with stage IB-IV mycosis fungoides or Sezary syndrome types of T-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Magrolimab and mogamulizumab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Treatment with magrolimab in combination with mogamulizumab may stabilize cancer for longer period than the usual treatment in patients with relapsed/refractory T-cell lymphoma who have been previously treated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2021
Typical duration for phase_1
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2020
CompletedFirst Posted
Study publicly available on registry
September 9, 2020
CompletedStudy Start
First participant enrolled
April 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 24, 2024
CompletedResults Posted
Study results publicly available
October 16, 2025
CompletedOctober 16, 2025
September 1, 2025
3.6 years
September 5, 2020
September 30, 2025
September 30, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Recommended Phase 2 Dose (RP2D) of Magrolimab When Given in Combination With Mogamulizumab (Phase Ib)
The phase 1b portion of the trial was designed to determine a RP2D of Hu5F9-G4 (magrolimab) and was planned to enroll 6-18 patients.
Up to 4 weeks from the first infusion of magrolimab (priming infusion)
Overall Response Rate at 6 Months (ORR6) (Phase II)
Will be defined as the proportion of patients who have a partial or complete response to therapy AND a duration of response \>= 6 months. Will use a stratified Cochran-Mantel-Haenszel chi-squared test to compare between-group differences in ORR6 proportion. Will also conduct a secondary analysis on the intent-to-treat population (all patients randomized to a therapy and assigned a study number) and an efficacy evaluable set (all patients who received the first 12 weeks of treatment and completed the week 12 response assessment).
At 6 months
Secondary Outcomes (6)
Overall Response Rate (ORR) (Phase Ib)
Up to 2 years
Overall Response Rate at 4 Months (ORR4) (Phase II)
At 4 months
Overall Response Rate at 12 Months (ORR12) (Phase II)
At 12 months
Progression-free Survival (PFS) (Phase II)
From start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years
Duration of Response (DOR) (Phase II)
From the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrence or progressive disease is objectively documented, assessed up to 2 years
- +1 more secondary outcomes
Study Arms (2)
Arm I (magrolimab, mogamulizumab), Phase Ib and Phase II
EXPERIMENTALPatients 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.
Arm II (mogamulizumab), Phase II
ACTIVE COMPARATORPatients 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.
Interventions
Undergo blood sample collection
Undergo PET/CT or diagnostic CT
Given IV
Given IV
Undergo PET/CT
Undergo skin punch biopsy
Eligibility Criteria
You may qualify if:
- Diagnosis of either mycosis fungoides (MF) or Sezary syndrome (SS) by the World Health Organization (WHO) 2016 classification (Swerdlow et al., 2017), stage IB-IV by modified International Society for Cutaneous Lymphomas (ISCL)/ European Organization of Research and Treatment of Cancer (EORTC) classification (Olsen et al., 2011), without large cell transformation (LCT) at the time of screening. Patients with a history of prior LCT are permitted
- Patients must have had at least one prior course of systemic therapy
- Age \>= 18 years
- Because no dosing or adverse event data are currently available on the use of Hu5F9-G4 (magrolimab) in combination with mogamulizumab in patients \<18 years of age, children are excluded from this study, but will be eligible for future pediatric trials
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
- Hemoglobin \>= 9.5 g/dL and transfusion independence (defined as not requiring more than 2 units of red blood cell \[RBC\] transfusions during the 4-week period prior to screening)
- Absolute neutrophil count \>= 1,000/mcL
- Platelets \>= 75,000/mcL
- Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) except for subjects with Gilbert's syndrome or genetic equivalent
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x institutional ULN
- Glomerular filtration rate (GFR) \>= 40 mL/min/1.73 m\^2 by the Cockcroft-Gault formula
- Patients must meet the following minimum wash-out window from previous treatments to the first treatment
- \>= 3 weeks for systemic anti-cancer therapies
- \>= 2 weeks for phototherapy, local radiation therapy, topical high potency corticosteroid, topical retinoid, topical nitrogen mustard, or topical toll-like receptor (TLR)-agonist
- \>= 12 weeks for total skin electron beam therapy Participants with rapidly progressive malignant disease may be enrolled prior to completion of the above periods with approval of the protocol director
- +11 more criteria
You may not qualify if:
- Prior treatment with Hu5F9-G4 (magrolimab) or any agent targeting CD47-SIRPalpha
- Prior progression of disease with mogamulizumab
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia and lymphopenia (any grade permitted). Residual peripheral neuropathy must have improved to grade 2 or better
- Patients who are receiving any other investigational agents
- Allogeneic hematopoietic stem cell transplant recipients with any graft-versus-host disease within the previous 3 months or requiring immunosuppression
- Active autoimmune disease that has required systemic immunosuppressive medication within the previous 3 months
- Active herpes simplex or herpes zoster. Subjects on prophylaxis for herpes who have no active signs of active infection, and whose last active infection was more than 6 months ago, may enter the study, and should continue to take the prescribed medication for the duration of the study
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Hu5F9-G4 (magrolimab), other monoclonal antibodies, or other agents (mogamulizumab) used in study
- Significant cardiopulmonary disease defined as
- Acute myocardial infarction within the last 6 months
- Unstable angina
- Congestive heart failure New York Heart Association (NYHA) class III-IV
- Patients with uncontrolled intercurrent illness requiring antibiotics. Patients on prophylactic antibiotics for non-complicated staphylococcus colonization/infection are eligible
- Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are excluded
- Patients with psychiatric illness/social situations or substance abuse that would limit compliance with study requirements
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
Los Angeles General Medical Center
Los Angeles, California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304, United States
Northwestern University
Chicago, Illinois, 60611, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
NYP/Weill Cornell Medical Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Paul Frankel, Ph.D.
- Organization
- City of Hope
Study Officials
- PRINCIPAL INVESTIGATOR
Michael S Khodadoust
City of Hope Comprehensive Cancer Center LAO
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2020
First Posted
September 9, 2020
Study Start
April 6, 2021
Primary Completion
October 24, 2024
Study Completion
October 24, 2024
Last Updated
October 16, 2025
Results First Posted
October 16, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.