Trial Outcomes & Findings for 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 (NCT NCT04541017)

Last Updated: 2025-10-16

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

8 participants

Primary outcome timeframe

Up to 4 weeks from the first infusion of magrolimab (priming infusion)

Results posted on

2025-10-16

Participant Flow

Eight patients were enrolled in the Phase Ib portion of the study. However, due to early study termination, two patients did not initiate treatment. As a result, six patients were included in the final analysis.

Participant milestones

Participant milestones
Measure	Arm I (Magrolimab, Mogamulizumab), Phase Ib and Phase II 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. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo PET/CT or diagnostic CT Magrolimab: Given IV Mogamulizumab: Given IV Positron Emission Tomography: Undergo PET/CT Punch Biopsy: Undergo skin punch biopsy	Arm II (Mogamulizumab), Phase II 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. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo PET/CT or diagnostic CT Mogamulizumab: Given IV Positron Emission Tomography: Undergo PET/CT Punch Biopsy: Undergo skin punch biopsy
Overall Study STARTED	6	0
Overall Study COMPLETED	6	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Magrolimab, Mogamulizumab), Phase Ib and Phase II n=6 Participants 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. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo PET/CT or diagnostic CT Magrolimab: Given IV Mogamulizumab: Given IV Positron Emission Tomography: Undergo PET/CT Punch Biopsy: Undergo skin punch biopsy	Arm II (Mogamulizumab), Phase II 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. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo PET/CT or diagnostic CT Mogamulizumab: Given IV Positron Emission Tomography: Undergo PET/CT Punch Biopsy: Undergo skin punch biopsy	Total n=6 Participants Total of all reporting groups
Age, Continuous	50 years n=5 Participants	—	50 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	—	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	—	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	—	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	—	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 4 weeks from the first infusion of magrolimab (priming infusion)

Population: The study was closed following a full clinical hold issued by the FDA for magrolimab, as well as the sponsor's decision to discontinue further development of the drug.

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.

Outcome measures

Outcome measures
Measure	Arm I (Magrolimab, Mogamulizumab), Phase Ib and Phase II n=6 Participants 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. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo PET/CT or diagnostic CT Magrolimab: Given IV Mogamulizumab: Given IV Positron Emission Tomography: Undergo PET/CT Punch Biopsy: Undergo skin punch biopsy	Arm II (Mogamulizumab), Phase II 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. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo PET/CT or diagnostic CT Mogamulizumab: Given IV Positron Emission Tomography: Undergo PET/CT Punch Biopsy: Undergo skin punch biopsy
Recommended Phase 2 Dose (RP2D) of Magrolimab When Given in Combination With Mogamulizumab (Phase Ib)	30 mg/kg	—

PRIMARY outcome

Timeframe: At 6 months

Population: The Phase II portion of the study was never opened. The study was closed following a full clinical hold issued by the FDA for magrolimab, as well as the sponsor's decision to discontinue further development of the drug.

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: The study was closed following a full clinical hold issued by the FDA for magrolimab, as well as the sponsor's decision to discontinue further development of the drug.

Defined as the proportion of patients who have a partial or complete response to therapy as defined by the global response score.

Outcome measures

Outcome measures
Measure	Arm I (Magrolimab, Mogamulizumab), Phase Ib and Phase II n=6 Participants 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. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo PET/CT or diagnostic CT Magrolimab: Given IV Mogamulizumab: Given IV Positron Emission Tomography: Undergo PET/CT Punch Biopsy: Undergo skin punch biopsy	Arm II (Mogamulizumab), Phase II 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. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo PET/CT or diagnostic CT Mogamulizumab: Given IV Positron Emission Tomography: Undergo PET/CT Punch Biopsy: Undergo skin punch biopsy
Overall Response Rate (ORR) (Phase Ib)	2 Participants	—

Adverse Events

Arm I (Magrolimab, Mogamulizumab), Phase Ib and Phase II

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Arm II (Mogamulizumab), Phase II

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I (Magrolimab, Mogamulizumab), Phase Ib and Phase II n=6 participants at risk 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. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo PET/CT or diagnostic CT Magrolimab: Given IV Mogamulizumab: Given IV Positron Emission Tomography: Undergo PET/CT Punch Biopsy: Undergo skin punch biopsy	Arm II (Mogamulizumab), Phase II 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. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo PET/CT or diagnostic CT Mogamulizumab: Given IV Positron Emission Tomography: Undergo PET/CT Punch Biopsy: Undergo skin punch biopsy
General disorders Fever	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post-discontinuation of treatment, up to two years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	— 0/0 • Adverse events were assessed from the time of initial treatment until 30 days post-discontinuation of treatment, up to two years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Skin infection	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post-discontinuation of treatment, up to two years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	— 0/0 • Adverse events were assessed from the time of initial treatment until 30 days post-discontinuation of treatment, up to two years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Upper respiratory infection	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post-discontinuation of treatment, up to two years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	— 0/0 • Adverse events were assessed from the time of initial treatment until 30 days post-discontinuation of treatment, up to two years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Other adverse events

Additional Information

Paul Frankel, Ph.D.

City of Hope

Phone: 6262185265

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60