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Trial Title:
A Study to Learn About the Study Medicine (Maplirpacept) in People With Advanced Non-Hodgkin Lymphoma or Multiple Myeloma in China
NCT ID:
NCT05896774
Condition:
Non-Hodgkin Lymphoma
Multiple Myeloma
Conditions: Official terms:
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma, Non-Hodgkin
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Maplirpacept
Description:
Study drug will be administered intravenously with adjustment for body weight weekly over
28-day cycles.
Arm group label:
Maplirpacept (PF-07901801)
Other name:
PF-07901801
Other name:
TTI-622
Summary:
The purpose of this study is to learn about the safety and what the body does to the
medicine (Maplirpacept) when taken for the treatment of non-Hodgkin lymphoma or multiple
myeloma.
Non-Hodgkin lymphoma is any of a large group of cancers of lymphocytes (white blood
cells). Multiple myeloma is a type of cancer that begins in plasma cells (white blood
cells that produce antibodies).
This study is seeking participants who:
- have non-Hodgkin lymphoma or multiple myeloma.
- have worsened with (or lack of improvement to) a standard treatment taken before.
- have relatively normal functioning organs.
All participants in this study will receive Maplirpacept as an intravenous (IV) infusion
(given directly into a vein) at the study clinic every week.
Participants will continue to receive Maplirpacept until:
- the cancer worsens.
- some serious side effects show up.
- the participants do not wish to take the study medicine any more.
The experiences of the people receiving the study medicine will be collected. This will
help to understand if the study medicine Maplirpacept, is safe and can be given to
Chinese people.
Detailed description:
The study is composed of 2 parts. In Part A, approximately 3-6 participants are expected
to be enrolled to confirm the tolerability in Chinese participants. If deemed safe, the
enrollment of Part B will proceed to include a total of approximately 9 participants in
the study to continue to evaluate the pharmacokinetics, safety and preliminary efficacy
of single agent PF-07901801 (Maplirpacept).
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Histologically confirmed relapsed/refractory non-Hodgkin lymphoma without other
effective therapeutic option. Or relapsed/refractory multiple myeloma exposed to
therapies including PI, IMiD and anti-CD38 antibody.
- With measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
- Adequate organ functions (including hematologic status, coagulation, hepatic, and
renal)
Key Exclusion Criteria:
- Active plasma cell leukemia, or POEMS syndrome.
- Known, current central nervous system disease involvement.
- Significant cardiovascular disease.
- Chronic use of systemic corticosteroids of more than 20 mg/day of prednisone or
equivalent.
- Radiation therapy within 14 days of study treatment administration.
- Hematopoietic stem cell transplant within 90 days before the planned start of study
treatment or participants with active GVHD disease.
- Use of any anticancer drug within 14 days before planned start of study treatment.
- Prior anti-CD47 or anti-SIRP alpha therapy.
- Participation in other studies involving investigational drug(s) or vaccines within
4 weeks from the last dose
- Known active, uncontrolled bacterial, fungal, or viral infection.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Facility:
Name:
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310016
Country:
China
Facility:
Name:
Sir Run Run Shaw Hospital
Address:
City:
Hangzhou
Zip:
310016
Country:
China
Facility:
Name:
The First Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Zip:
325000
Country:
China
Start date:
June 28, 2023
Completion date:
May 5, 2025
Lead sponsor:
Agency:
Pfizer
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/NCT05896774
https://pmiform.com/clinical-trial-info-request?StudyID=C4971010
