18 and older, any sex, with Diffuse Large B-Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs)Primary· Cycle 1 (28 Days)
DLTs included: Hematological: Grade (G) 4 thrombocytopenia (\<25,000/microliter \[mcL\]) lasting \>=72 hours or a platelet count \<=10,000/mcL at any time, unexplained by underlying disease; \>=G3 thrombocytopenia associated with \>=G2 bleeding, unexplained by underlying disease. G4 anemia; unexplained by underlying disease; G4 neutropenia lasting \>=7 days, unexplained by underlying disease; G3 febrile (\>38.3-degree Celsius \[C\]) neutropenia lasting \>=7 days, unexplained by underlying disease; G4 febrile neutropenia unexplained by underlying disease. Non-hematological: any treatment-relate
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
0
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
0
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
0
Phase 1b: Number of Participants With Treatment Emergent Adverse Events (TEAEs)Secondary· From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs are those events with onset dates occurred during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period.
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
3
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
2
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
1
Phase 1b: Number of Participants With Serious Treatment Emergent Adverse EventsSecondary· From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/ incapacity, was a congenital anomaly/birth defect or other important medical event. TEAEs are those events with onset
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
3
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
0
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
0
Phase 1b: Number of Participants With Treatment-Related AEsSecondary· From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Related AEs were those related to any study drug (i.e., at least one of the study drugs) reported by the investigator.
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
3
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
2
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
1
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baselineSecondary· From baseline (latest non-missing value from pre-treatment period) up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
The following hematological parameters were assessed: anemia, hemoglobin increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, and white blood cell (WBC) decreased. Lab abnormalities were graded according to National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) version (v) 5.0 where Grade 0= no AE, Grade 1= mild AE, Grade 2 =moderate AE, Grade 3= severe AE, and Grade 4= life-threatening consequences; urgent intervention indicated. Only those parameters with at least 1 non-zero data values showi
Anemia: Grade 1 to Grade 2
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
1
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
0
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
0
Anemia: Grade 2 to Grade 3
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
1
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
0
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
0
Leukocytosis: Grade 0 Grade 3
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
1
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
0
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
0
Lymphocyte count decreased: Grade 0 to Grade 2
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
0
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
1
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
1
Lymphocyte count decreased: Grade 0 to Grade 3
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
1
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
0
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
0
Lymphocyte count decreased: Grade 1 to Grade 2
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
1
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
0
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
0
Lymphocyte count decreased: Grade 1 to Grade 3
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
0
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
1
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
0
Lymphocyte count increased: Grade 0 Grade 2
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
1
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
0
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
0
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post BaselineSecondary· From baseline (latest non-missing value from pre-treatment period) up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
The following clinical chemistry parameters were assessed: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia and hyponatremia. Lab abnormalities were graded according to NCI CTCAE v5.0 where Grade 0= no AE, Grade 1=mild AE, Grade 2 = moderate AE, Grade 3 =severe AE, and Grade 4 =life-threatening consequences; urgent intervention indicated. Only those paramete
Alanine aminotransferase increased: Grade 0 to Grade 1
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
1
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
1
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
1
Alanine aminotransferase increased: Grade 1 to Grade 0
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
0
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
1
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
0
Alkaline phosphatase increased: Grade 0 to Grade 1
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
2
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
1
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
0
Alkaline phosphatase increased: Grade 1 to Grade 0
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
1
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
0
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
0
Aspartate aminotransferase increased: Grade 0 to Grade 1
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
1
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
2
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
0
Blood bilirubin increased: Grade 0 to Grade 1
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
1
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
0
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
0
Blood bilirubin increased: Grade 0 to Grade 2
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
1
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
0
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
0
Creatinine increased: Grade 0 to Grade 1
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
0
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
1
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
0
Phase 1b: Percentage of Participants With Objective Response (OR) as Per Lugano Response Classification Criteria 2014 as Assessed by the InvestigatorSecondary· From date of first dose until first documentation of disease progression (PD), death or start of new anticancer therapy, whichever occurred first (maximum up to 14.2 months)
OR:best overall response (BOR) of complete response (CR) or partial response (PR) per Lugano Response Classification Criteria 2014 as determined by investigator. CR:positron emission tomography-computed tomography (PET-CT) score 1 (complete metabolic response), 2 (likely benign), or 3 (uncertain significance) with or without a residual mass on Deauville five-point scale (\[5PS\] standardized scoring system used to evaluate the extent of disease activity in patients with lymphoma through PET scans, ranging from 1 to 5, higher scores indicates more disease activity) or on computed tomography (CT
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
66.7
12.5 – 98.2
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
100.0
19.8 – 100.0
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
0
0 – 94.5
Phase 1b: Duration of Response (DoR) as Per Lugano Response Classification Criteria 2014 as Assessed by the InvestigatorSecondary· From first documentation of OR until PD or death due to any cause whichever occurred first or date of censoring (maximum up to 14.2 months)
DoR: time from first documentation of OR until PD, or death due to any cause, whichever occurred first. DoR was censored on date of last adequate disease assessment for participants without an event. OR=BOR of CR or PR,CR=PET-CT score 1,2,or 3 with/without a residual mass on Deauville five-point scale(1 to 5,higher scores=more disease activity)or on CT,target nodes/nodal masses regressed to \<=1.5cm in LDi. PR:PET-CT score 4 or 5 with reduced uptake compared with baseline and residual mass of any size or On CT \>=50% decrease in SPD of up to 6 target measurable nodes and extra nodal sites. PD:
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
11.9
9.6 – NA
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
NA
3.3 – NA
Phase 1b: Percentage of Participants With CR as Per Lugano Response Classification Criteria 2014 as Assessed by the InvestigatorSecondary· From date of first dose until first documentation of CR (maximum up to 14.2 months)
CR as per Lugano Response Classification Criteria 2014 as assessed by the investigator was defined as: PET-CT score 1 (complete metabolic response), 2 (likely benign), or 3 (uncertain significance) with or without a residual mass on 5PS (standardized scoring system used to evaluate the extent of disease activity in patients with lymphoma through PET scans, ranging from 1 to 5, higher scores indicates more disease activity) or on CT, target nodes/nodal masses regressed to \<=1.5 cm in LDi.
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
66.7
12.5 – 98.2
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
100.0
19.8 – 100.0
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
0.0
NA – NA
Phase 1b: Duration of Complete Response (DoCR) as Per Lugano Response Classification Criteria 2014 as Assessed by the InvestigatorSecondary· From time of first documentation of CR until PD, or death due to any cause, whichever occurred first or date of censoring (maximum up to 14.2 months)
DoCR:time from first documentation of CR until PD,or death, whichever occurred first. CR:PET-CT 1(complete metabolic response),2(likely benign),3(uncertain significance)with or without residual mass on 5PS(scale from 1 to 5,higher scores=more disease activity)/CT,target nodes/nodal masses regressed \<=1.5cm in LDi.PD:PET-CT 4(possible residual disease)or 5(PD)with increase intensity of uptake and new FDG-avid foci consistent with lymphoma at interim/EOT assessment/CT,individual abnormal node/lesion with:LDi \>1.5cm and increase \>=50% from PPD nadir, increase in LDi or SDi from nadir 0.5cm for
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
11.9
9.6 – NA
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
NA
3.3 – NA
Phase 1b: Progression Free Survival (PFS) as Per Lugano Response Classification Criteria 2014 as Assessed by the InvestigatorSecondary· From date of first dose until PD or death due to any cause, whichever occurred first or censoring date (maximum up to 14.2 months)
PFS: time from date of first dose until PD per Lugano Response Classification Criteria 2014 or death due to any cause,whichever occurred first.Participants without any event,censored on date of last adequate disease assessment;participants with new anticancer therapy prior to an event,censored on date of last disease assessment before new anticancer therapy;participants with an event after a gap of 2 or more missing disease assessments,censored on date of last disease assessment before gap;participants without an adequate post-baseline disease assessment were censored on date of first dose of
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
13.7
11.4 – NA
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
NA
5.6 – NA
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
1.2
NA – NA
Phase 1b: Plasma Concentration of PF-07901801Secondary· Cycle 1 and 2 Day 1: Predose, 1 Hour (H) and 5H post dose; Cycle 1 Day 8: pre-dose, Day 1 of Cycles 3, 4, 5, 7, 10 and 13: Predose
All concentrations assayed below the level of quantification (BLQ) were set to 0 and their data is not reported in this outcome measure.
Cycle 1 Day 1: Predose
Group
Value
95% CI
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
0.1
± NA
Cycle 1 Day 1: 1 hour
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
64.3
± 45
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
213.4
± 31
Cycle 1 Day 1: 5 hours
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
50.7
± 47
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
194.2
± 42
Cycle 1 Day 8: Predose
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
4.0
± 159
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
21.1
± 85
Cycle 2 Day 1: Predose
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
7.9
± 201
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
88.3
± 35
Cycle 2 Day 1: 1 hour
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
75.3
± 63
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
308.1
± 42
Cycle 2 Day 1: 5 hours
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
67.6
± 71
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
276.4
± 31
Cycle 3 Day 1: Predose
Group
Value
95% CI
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
10.9
± 168
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
130.4
± 10
Adverse events — posted to ClinicalTrials.gov
Time frame: From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
Serious: 3/3 (100%)
Deaths: 2/3
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
Serious: 0/2 (0%)
Deaths: 0/2
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
Serious: 0/1 (0%)
Deaths: 0/1
Serious adverse events (6 terms)
Reaction
System
PF-07901801 4 mg/kg + Tafa…
PF-07901801 10 mg/kg + Taf…
PF-07901801 18 mg/kg + Taf…
Sepsis
Infections and infestations
—
—
—
Appendicitis
Infections and infestations
—
—
—
Pneumonia
Infections and infestations
—
—
—
Leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study is to learn about the effects of three study medicines \[maplirpacept (PF-07901801), tafasitamab, and lenalidomide\] when given together for the treatment of diffuse large B-cell lymphoma (DLBCL) that:
* is relapsed (has returned after last treatment) or
* is refractory (has not responded to last treatment)
DLBCL is a type of non-Hodgkin lymphoma (NHL). NHL is a cancer of the lymphatic system. It develops when the body makes abnormal lymphocytes. These lymphocytes are a type of white blood cell that normally help to fight infections.
This study is seeking participants who are unable or unwilling to undergo an autologous stem cell transplantation (when doctors put healthy blood cells back into your body) or CAR-T immune cell therapy.
Everyone in this study will receive three medicines: maplirpacept (PF-07901801), tafasitamab and lenalidomide. Participants will receive maplirpacept (PF-07901801) and tafasitamab at the study clinic by intravenous (IV) infusion (given directly into a vein) and lenalidomide will be taken by mouth at home. Study interventions will be administered in 28-day cycles. Maplirpacept (PF-07901801) will be given weekly for the first three cycles and then every two weeks. Tafasitamab will administered on Days 1, 4, 8, 15 and 22 in cycle 1, weekly in cycles 2 and 3 and then every 2 weeks in cycle 4 and beyond. Lenalidomide will be taken every day for Days 1 to 21 of each 28-day cycle for the first 12 cycles.
Participants can continue to take maplirpacept (PF-07901801) and tafasitamab until their lymphoma is no longer responding. Lenalidomide is discontinued after 12 cycles.
Maplirpacept (PF-07901801) will be given at different doses to different participants. Everyone taking part will receive approved doses of tafasitamab and lenalidomide. We will compare the experiences of people receiving different doses of PF-07901801. This will help us to determine what dose is safe and effective when combined with the other 2 study medicines.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05896774 — A Study to Learn About the Study Medicine (Maplirpacept) in People With Advanced Non-Hodgkin Lymphoma or Multiple Myelom
· Phase 1
· completed
NCT05507541 — TTI-622 in Combination With Pembrolizumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma
· Phase 2
· active not recruiting
NCT05675449 — A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relap
· Phase 1
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 5 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05626322.