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

NCT ID: NCT05896774

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-28

Study Completion Date

2024-11-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Hodgkin Lymphoma Multiple Myeloma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Maplirpacept (PF-07901801)

single arm study

Group Type EXPERIMENTAL

Maplirpacept

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Maplirpacept

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PF-07901801 TTI-622

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Site Status

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Related Links

Access external resources that provide additional context or updates about the study.

https://pmiform.com/clinical-trial-info-request?StudyID=C4971010

To obtain contact information for a study center near you, click here.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C4971010

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Gemcitabine for Marginal Zone Lymphoma
NCT00337259 TERMINATED PHASE2
Decitabine and Anti-PD-1 in R/R DLBCL
NCT05816746 RECRUITING PHASE2