Trial Title:
Effects of Maplirpacept (PF-07901801),Tafasitamab, and Lenalidomide in People With Relapsed or Refractory Diffuse Large B-cell Lymphoma
NCT ID:
NCT05626322
Condition:
Diffuse Large B-Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lenalidomide
Conditions: Keywords:
DLBCL
Lymphoma
Relapsed
Refractory
CD19
CD47
Maplirpacept
Tafasitamab
Lenalidomide
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Open label/randomized
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Maplirpacept
Description:
Intravenous infusion
Arm group label:
Phase 1b
Arm group label:
Phase 2
Other name:
PF-07901801, TTI-622
Intervention type:
Drug
Intervention name:
Tafasitamab
Description:
Intravenous infusion
Arm group label:
Phase 1b
Arm group label:
Phase 2
Other name:
Minjuvi, Monjuvi
Intervention type:
Drug
Intervention name:
Lenalidomide
Description:
Oral (by mouth)
Arm group label:
Phase 1b
Arm group label:
Phase 2
Other name:
Revlimid
Summary:
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.
Detailed description:
This is a multicenter, open-label, Phase 1b/2 study to evaluate the safety, tolerability
and potential clinical benefits of maplirpacept (PF-07901801), an anti-CD47 molecule, in
combination with standard doses of tafasitamab and lenalidomide in participants with
relapsed/refractory (R/R) DLBCL not eligible for or unwilling to undergo high dose
chemotherapy and subsequent autologous stem cell transplantation (ASCT) or unable to
receive approved chimeric antigen receptor T-cell (CAR-T) therapy (for example, due to
logistical limitations).
For Phase 1b, participants must have previously received at least 1 prior systemic
treatment regimen. For Phase 2, participants must have received at least 1 but no more
than 2 prior systemic treatment regimens. All participants must have previously received
an anti-CD20 containing regimen.
Phase 1b will assess dose-limiting toxicities of maplirpacept (PF-07901801) when
administered in combination with tafasitamab and lenalidomide, to select up to 2 doses
for the Phase 2 part of the study. Phase 2 will evaluate safety and efficacy to determine
the recommended Phase 3 dose of Maplirpacept (PF-07901801) to be administered in
combination with tafasitamab and lenalidomide.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Histologically confirmed diagnosis of DLBCL
- Relapsed or refractory disease
- Participant is not be a candidate for or is unwilling to undergo high dose
chemotherapy and subsequent stem cell transplant and/or is unable to receive
chimeric antigen receptor (CAR) T-cell therapy
- Previous treatment with at least one prior line of systemic therapy (for phase 2, at
least 1 and no more than 2 prior lines of systemic therapy). Prior therapy must
include an anti-CD20 antibody.
- Adequate bone marrow, hepatic and renal function
- Eastern Cooperative Oncology Group (ECOG) ≤2
- Must provide a tumor tissue sample (fresh or archival, collected prior to start of
treatment) for biomarker analysis
Key Exclusion Criteria:
- Prior treatment with an anti-CD47 or anti-CD19 (other than CAR T) or
immunomodulatory agents
- Prior allogeneic stem cell transplantation or autologous stem cell transplantation
within 12 weeks prior to enrolment
- Participants with active, uncontrolled bacterial, fungal or viral infection.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Facility:
Name:
LSU Health Baton Rouge North Clinic
Address:
City:
Baton Rouge
Zip:
70805
Country:
United States
Facility:
Name:
Our Lady of the Lake Physician Group-Medical Oncology
Address:
City:
Baton Rouge
Zip:
70808
Country:
United States
Facility:
Name:
Our Lady of the Lake RMC
Address:
City:
Baton Rouge
Zip:
70808
Country:
United States
Facility:
Name:
Mary Bird Perkins Cancer Center
Address:
City:
Baton Rouge
Zip:
70809
Country:
United States
Facility:
Name:
Our Lady of the Lake RMC
Address:
City:
Baton Rouge
Zip:
70809
Country:
United States
Facility:
Name:
University of Michigan
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Facility:
Name:
Lifespan Cancer Institute
Address:
City:
Providence
Zip:
02903
Country:
United States
Facility:
Name:
The Miriam Hospital
Address:
City:
Providence
Zip:
02906
Country:
United States
Facility:
Name:
Thompson Cancer Survival Center
Address:
City:
Knoxville
Zip:
37916
Country:
United States
Facility:
Name:
Thompson Cancer Survival Center West
Address:
City:
Knoxville
Zip:
37932
Country:
United States
Facility:
Name:
Thompson Oncology Group - West
Address:
City:
Knoxville
Zip:
37932
Country:
United States
Facility:
Name:
Thompson Oncology Group - Lenoir City
Address:
City:
Lenoir City
Zip:
37772
Country:
United States
Facility:
Name:
Thompson Oncology Group
Address:
City:
Maryville
Zip:
37804
Country:
United States
Facility:
Name:
Thompson Oncology Group - Oak Ridge
Address:
City:
Oak Ridge
Zip:
37830
Country:
United States
Facility:
Name:
Japanese Foundation for Cancer Research
Address:
City:
Koto
Zip:
135-8550
Country:
Japan
Facility:
Name:
The Cancer Institute Hospital of JFCR
Address:
City:
Koto
Zip:
135-8550
Country:
Japan
Facility:
Name:
Kyushu University Hospital
Address:
City:
Fukuoka
Zip:
812-8582
Country:
Japan
Facility:
Name:
Yamagata University Hospital
Address:
City:
Yamagata
Zip:
990-9585
Country:
Japan
Facility:
Name:
Dong-A University Hospital
Address:
City:
Busan
Zip:
49201
Country:
Korea, Republic of
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Facility:
Name:
Auxilio Mutuo Cancer Center
Address:
City:
San Juan
Zip:
00918
Country:
Puerto Rico
Start date:
August 4, 2023
Completion date:
May 1, 2025
Lead sponsor:
Agency:
Pfizer
Agency class:
Industry
Collaborator:
Agency:
MorphoSys AG
Agency class:
Industry
Collaborator:
Agency:
Incyte Corporation
Agency class:
Industry
Source:
Pfizer
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05626322
https://pmiform.com/clinical-trial-info-request?StudyID=C4971003
