Trial Title:
A Study to Learn About the Effects of Two Study Medicines (Maplirpacept [PF-07901801] And Glofitamab) When Given Together In People With Relapsed Or Refractory Diffuse Large B Cell Lymphoma.
NCT ID:
NCT05896163
Condition:
Diffuse Large B-Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Obinutuzumab
Conditions: Keywords:
DLBCL
Lymphoma
Relapsed
Refractory
CD20
CD3
CD47
Glofitamab
Obinutuzumab
Maplirpacept
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
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 (PF-07901801)
Description:
Intravenous infusion
Arm group label:
Phase 1b
Arm group label:
Phase 2
Intervention type:
Drug
Intervention name:
Glofitamab
Description:
Intravenous infusion
Arm group label:
Phase 1b
Arm group label:
Phase 2
Intervention type:
Drug
Intervention name:
Obinutuzumab
Description:
Intravenous infusion
Arm group label:
Phase 1b
Arm group label:
Phase 2
Summary:
The purpose of this study is to learn about the effects of two study medicines
(maplirpacept [PF-07901801] and glofitamab) when given together for the treatment of
diffuse large B-cell lymphoma (DLBCL) that is relapsed or is refractory. Relapsed means
has returned after last treatment. Refractory means that it has not responded to last
treatment. The two study medicines are given after a single dose of obinutuzumab which is
the third study medicine.
DLBCL is a type of non-Hodgkin lymphoma (NHL). NHL is a cancer of the lymphatic system.
It develops when the body makes abnormal B lymphocytes. These lymphocytes are a type of
white blood cell that normally help to fight infections.
This study is seeking adult participants who:
- Have histologically confirmed diagnosis of DLBCL
- Have received at least two first lines of treatment for NHL.
- Are unable or unwilling to undergo a stem cell transplant or CAR-T cell therapy.
Stem cell transplant is a procedure in which a patient receives healthy blood-forming
cells to replace their own stem cells that have been destroyed by treatment.
A CAR-T therapy is a type of treatment in which a patient's T cells are changed in the
laboratory so they will attack cancer cells.
Everyone in this study will receive all three medicines at the study site by intravenous
(IV) infusion which is given directly into a vein. The two study medicines (maplirpacept
[PF-07901801] and glofitamab) will be given in 21-day cycles.
At Cycle 0, participants will receive a single dose of obinutuzumab pre-treatment
followed by two step-up doses of glofitamab. The combination of maplirpacept
(PF-07901801) with glofitamab full dose will be administered for the first time at Cycle
1 Day 1.
Maplirpacept (PF-07901801) will be given weekly for the first three cycles and then every
three weeks. Glofitamab will be given every 3 weeks for approximately 9 months.
Thereafter participants will continue to receive maplirpacept alone.
Maplirpacept (PF-07901801) will be given at different doses to different participants.
Everyone taking part will receive the same fixed doses of glofitamab and obinutuzumab
studied in patients with DLBCL.
The study will compare the experiences of people receiving different doses of
maplirpacept (PF-07901801). This will help to determine what dose is safe and effective
when given 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 fixed doses of glofitamab after a single dose of obinutuzumab 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 2 prior systemic
treatment regimen. For Phase 2, participants must have received at least 2 but no more
than 4 prior systemic treatment regimens. All participants must have previously received
an anti-CD20 containing regimen.
Phase 1b will assess dose-limiting toxicities of PF-07901801 when administered in
combination with glofitamab, 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
PF-07901801 to be administered in combination with glofitamab.
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 two prior lines of systemic therapy (for phase 2,
at least 2 and no more than 4 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
Key Exclusion Criteria:
- Prior treatment with anti-CD47 and/or prior glofitamab or anti-CD20 x CD3 containing
regimen. Refractoriness to an obinutuzumab monotherapy containing regimen.
- Prior allogeneic stem cell transplantation or autologous stem cell transplantation
within 12 weeks prior to enrolment
- High Grade B-Cell Lymphoma
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The University of Kansas Cancer Center ,Investigational Drug Services
Address:
City:
Fairway
Zip:
66205
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
The University of Kansas Cancer Center ,Investigational Drug Services
Address:
City:
Fairway
Zip:
66205
Country:
United States
Status:
Recruiting
Facility:
Name:
The University of Kansas Clinical Research Center
Address:
City:
Fairway
Zip:
66205
Country:
United States
Status:
Recruiting
Facility:
Name:
The University of Kansas Hospital
Address:
City:
Kansas City
Zip:
66160
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Kansas Hospital Cambridge North Tower A
Address:
City:
Kansas City
Zip:
66160
Country:
United States
Status:
Recruiting
Facility:
Name:
Allina Health Cancer Institute - Abbott Northwestern Hospital
Address:
City:
Minneapolis
Zip:
55407
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Siteman Cancer Center
Address:
City:
Saint Louis
Zip:
63108
Country:
United States
Status:
Recruiting
Facility:
Name:
Barnes-Jewish Hospital Parkview Tower
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Barnes-Jewish Hospital
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Swedish Cancer Institute
Address:
City:
Seattle
Zip:
98104
Country:
United States
Status:
Recruiting
Facility:
Name:
Swedish Medical Center
Address:
City:
Seattle
Zip:
98122
Country:
United States
Status:
Recruiting
Facility:
Name:
St Vincent's Hospital Melbourne
Address:
City:
Fitzroy
Zip:
3065
Country:
Australia
Status:
Not yet recruiting
Facility:
Name:
Sheba Medical Center
Address:
City:
Ramat Gan
Zip:
5262100
Country:
Israel
Status:
Recruiting
Facility:
Name:
Rambam Health Care Campus
Address:
City:
Haifa
Zip:
3109601
Country:
Israel
Status:
Recruiting
Facility:
Name:
Hadassah Medical Center
Address:
City:
Jerusalem
Zip:
9112001
Country:
Israel
Status:
Recruiting
Facility:
Name:
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Address:
City:
Nagoya
Zip:
466-8650
Country:
Japan
Status:
Recruiting
Facility:
Name:
Shizuoka Cancer Center
Address:
City:
Nagaizumi-cho,Sunto-gun
Zip:
411-8777
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Hospital Organization Kyushu Cancer Center
Address:
City:
Fukuoka
Zip:
811-1395
Country:
Japan
Status:
Recruiting
Facility:
Name:
China Medical University Hospital
Address:
City:
Taichung
Zip:
40447
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
10002
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Koo Foundation Sun Yat-Sen Cancer Center
Address:
City:
Taipei
Zip:
112
Country:
Taiwan
Status:
Recruiting
Start date:
August 30, 2023
Completion date:
October 15, 2028
Lead sponsor:
Agency:
Pfizer
Agency class:
Industry
Collaborator:
Agency:
Hoffmann-La Roche
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/NCT05896163
https://pmiform.com/clinical-trial-info-request?StudyID=C4971006
