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NCT05896774 | COMPLETED | Non-Hodgkin Lymphoma

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

Pfizer

Brief 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.

Condition or disease

Non-Hodgkin Lymphoma

Multiple Myeloma

Intervention/treatment

Maplirpacept

Phase

PHASE1

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).

Study Type : INTERVENTIONAL
Estimated Enrollment : 10 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : AN OPEN-LABEL, PHASE 1 STUDY EVALUATING THE PHARMACOKINETICS, SAFETY AND ANTI-TUMOR ACTIVITY OF PF-07901801 (TTI-622) MONOTHERAPY IN CHINESE PARTICIPANTS WITH ADVANCED HEMATOLOGIC MALIGNANCIES
Actual Study Start Date : 2023-06-28
Estimated Primary Completion Date : 2024-11-06
Estimated Study Completion Date : 2024-11-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
A Study to Learn About the Study Medicine (Maplirpacept) in People With Advanced Non-Hodgkin Lymphoma or Multiple Myeloma in China

Location Details

NCT05896774

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

China, Beijing

Beijing Cancer Hospital

Beijing, Beijing, China, 100142

Not yet recruiting

China, Guangdong

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China, 510080

Not yet recruiting

China, Zhejiang

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310016

Not yet recruiting

China, Zhejiang

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China, 310016

Not yet recruiting

China, Zhejiang

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China, 325000