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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05896774
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Pfizer
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Pfizer CT.gov Call Center
Principal Investigator Affiliation Pfizer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Non-Hodgkin Lymphoma, Multiple Myeloma
Study Website: View Trial Website
Additional Details

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).

Arms & Interventions

Arms

Experimental: Maplirpacept (PF-07901801)

single arm study

Interventions

Drug: - Maplirpacept

Study drug will be administered intravenously with adjustment for body weight weekly over 28-day cycles.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing Cancer Hospital, Beijing, Beijing, China

Status

Not yet recruiting

Address

Beijing Cancer Hospital

Beijing, Beijing, 100142

Beijing Cancer Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Beijing Cancer Hospital

Beijing, Beijing, 100142

Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China

Status

Not yet recruiting

Address

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080

Hangzhou, Zhejiang, China

Status

Recruiting

Address

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016

Sir Run Run Shaw Hospital, Hangzhou, Zhejiang, China

Status

Not yet recruiting

Address

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310016

Wenzhou, Zhejiang, China

Status

Not yet recruiting

Address

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000