A Study to Learn About the Study Medicine (Called Maplirpacept (PF-07901801)) in Japanese With Hematologic Malignancies

NCT ID: NCT05567887

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-02
• Study Completion Date: 2024-10-02

Brief Summary

The purpose of this clinical trial is to learn about how safe and tolerable is the study medicine (called maplirpacept (PF-07901801)) when taken for the treatment of lymphoma or multiple myeloma (a type of cancer that affects your body's infection-fighting cells, lymphocytes or plasma cell).

This study is seeking participants who:

• are 18 years of age or older
• have worsening and difficult to manage type of lymphoma or multiple myeloma
• Have adequately functioning organs
• are not on long term use of steroids which are given either by mouth or as shots
• have no major heart related disease etc.

All participants in this study will receive maplirpacept (PF-07901801) as an IV infusion (given directly into a vein) at the study clinic every week.

Participants will continue to receive maplirpacept (PF-07901801) until their progress of cancer worsens or the participants do not wish to take the study medicine.

The experiences of the people receiving the study medicine will be collected. This will help to understand if the study medicine maplirpacept (PF-07901801), is safe and can be given to Japanese people.

Detailed Description

CD47 is a cell-surface protein expressed on multiple normal cell types and often at high levels on many malignant tumor cells. Maplirpacept (PF-07901801) is a soluble recombinant fusion protein created by directly linking the sequences encoding the CD47 binding domain of human Signal Regulatory Protein alpha with the fragment crystallizable domain of human Immunoglobulin 4. maplirpacept (PF-07901801) functions as a soluble decoy receptor, preventing CD47 from delivering its antiphagocytic signal. Neutralization of the inhibitory CD47 signal enables macrophage activation and anti-tumor effects by pro-phagocytic signals present on the tumor cells.

The objective of this study is to confirm safety and tolerability of single agent maplirpacept (PF-07901801) at the recommended phase 3 dose in Japanese participants with relapsed or refractory lymphoma or multiple myeloma.

Conditions

Lymphoma; Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

maplirpacept (PF-07901801)

maplirpacept (PF-07901801)

Group Type: EXPERIMENTAL

maplirpacept (PF-07901801)

Intervention Type: DRUG

maplirpacept (PF-07901801)

Interventions

maplirpacept (PF-07901801)

maplirpacept (PF-07901801)

Intervention Type: DRUG

Other Intervention Names

TTI-622

Eligibility Criteria

Inclusion Criteria

• Relapsed or refractory lymphoma (Hodgkin's or non-Hodgkin's) or multiple myeloma
• Disease must have progressed with standard anticancer therapies
• measurable disease
• Capable of giving signed informed consent
• Eastern cooperative oncology group performance status 0 or 1
• Adequate organ functions

Exclusion Criteria

• Known, current central nervous system or interstitial lung disease involvement
• History of hemolytic anemia or positive direct antiglobulin test or active bleeding disorder
• Chronic use of systemic corticosteroids of more than 20 mg/day of prednisone or equivalent
• Significant cardiovascular disease
• Other significant medical condition unrelated to the primary malignancy
• Radiation therapy within 14 days of study treatment administration
• Hematopoietic stem cell transplant within 90 days before the planned start of study treatment
• Antiplatelet/anticoagulant agents within 14 days before planned start of study treatment
• Patients sustaining major surgery at least 4 weeks prior to study enrollment
• Use of any investigational agent or any anticancer drug within 14 days before planned start of study treatment
• Prior anti-CD47 and anti-Signal Regulatory Protein alpha therapy
• Active, uncontrolled bacterial, fungal, or viral infection
• Investigator site staff directly involved in the conduct of the study and their family members

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

Nagoya, Aichi-ken, Japan

Japanese Foundation for Cancer Research

Koto, Tokyo, Japan

The Cancer Institute Hospital of JFCR

Koto, Tokyo, Japan

Yamagata University Hospital

Yamagata, , Japan

Countries

Japan

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=C4971009

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

Other Identifiers

C4971009

Identifier Type: -

Identifier Source: org_study_id