A Study to Learn About the Study Medicine (Maplirpacept) in People With Advanced Non-Hodgkin Lymphoma or Multiple Myeloma in China

Pfizer

Status and phase

Completed

Phase 1

Conditions

Multiple Myeloma

Non-Hodgkin Lymphoma

Treatments

Drug: Maplirpacept

Study type

Interventional

Funder types

Industry

Identifiers

NCT05896774

C4971010

Details and patient eligibility

About

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.

Full 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).

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.