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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05896774
• Other study ID #: C4971010
• Status: Recruiting
• Phase: Phase 1
• Start date: June 28, 2023
• Est. completion date: May 27, 2025

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: May 27, 2025
• Est. primary completion date: February 26, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Non-Hodgkin Lymphoma

Intervention

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

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Beijing Cancer Hospital	Beijing	Beijing
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang
China	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Dose-Limiting Toxicity (DLT)	Part A only. To characterize the dose limiting toxicities (DLTs) of Maplirpacept.	Cycle 1:up to 21 days
Primary	Single-dose Cmax	Maximum Observed Plasma Concentration	0, 1, 2, 4, 24, 72 hours post-dose up to Day 8
Primary	Single-dose AUClast	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)	0, 1, 2, 4, 24, 72 hours post-dose up to Day 8
Primary	Single-dose AUCtau	Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 1 week.	0, 1, 2, 4, 24, 72 hours post-dose up to Day 8
Secondary	Number of Participants With Adverse Events (AEs) by type, frequency, severity (as graded by NCI CTCAE verision 5.0), timing, seriousness and relationship to study treatment	An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category. Relatedness to study drug was assessed by the investigator.	Baseline up to 28 days after the last dose of study drug
Secondary	Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing	Laboratory parameters included: hematology, blood chemistry and coagulation. Clinical significance of laboratory parameters was determined at the investigator's discretion.	Baseline up to 28 days after the last dose of study drug
Secondary	Single-dose Tmax (Time to Reach Maximum Observed Plasma Concentration)	Pharmacokinetics of Maplirpacept	0, 1, 2, 4, 24, 72 hours post-dose up to Day8
Secondary	Multiple-dose Cmax (Maximum Observed Plasma Concentration)	Pharmacokinetics of Maplirpacept	Through study completion, up to 18 months
Secondary	Multiple-dose Ctrough (trough concentration)	Pharmacokinetics of Maplirpacept	Through study completion, up to 18 months
Secondary	Multiple-dose Cmin (Minimum Observed Plasma Trough Concentration)	Pharmacokinetics of Maplirpacept	Through study completion, up to 18 months
Secondary	Multiple-dose Tmax (Time to Reach Maximum Observed Plasma Concentration)	Pharmacokinetics of Maplirpacept	Through study completion, up to 18 months
Secondary	Multiple-dose AUClast (Area under the plasma concentration time-curve from zero to the last measured concentration)	Pharmacokinetics of Maplirpacept	Through study completion, up to 18 months
Secondary	Multiple-dose AUCtau (Area Under the Curve from Time Zero to end of dosing interval)	Pharmacokinetics of Maplirpacept	Through study completion, up to 18 months
Secondary	Multiple-dose Rac (Accumulation Ratio)	Pharmacokinetics of Maplirpacept	Through study completion, up to 18 months
Secondary	CL (Systemic Clearance)	Pharmacokinetics of Maplirpacept	Through study completion, up to 18 months
Secondary	Vss (Volume of Distribution at Steady State)	Pharmacokinetics of Maplirpacept	Through study completion, up to 18 months
Secondary	t½ (Plasma Decay Half-Life)	Pharmacokinetics of Maplirpacept	Through study completion, up to 18 months
Secondary	AUCinf (Area Under the Curve From Time Zero to Extrapolated Infinite Time)	Pharmacokinetics of Maplirpacept	Through study completion, up to 18 months
Secondary	Incidence and titers of anti-drug antibodies against TTI-622	Pharmacokinetics of Maplirpacept	Through study completion, up to 18 months
Secondary	Incidence and titers of neutralizing antibodies against TTI-622	Pharmacokinetics of Maplirpacept	Through study completion, up to 18 months
Secondary	Objective Response	To assess the preliminary antitumor activity of Maplirpacept	Baseline to measured progressive disease, up to 18 months
Secondary	Time to Tumor Response (TTR)	To assess the preliminary antitumor activity of Maplirpacept	Baseline to measured progressive disease, up to 18 months
Secondary	Duration of Response (DOR)	To assess the preliminary antitumor activity of Maplirpacept	Baseline to measured progressive disease, up to 18 months
Secondary	Progression-Free Survival (PFS)	To assess the preliminary antitumor activity of Maplirpacept	Baseline to measured progressive disease, up to 18 months
Secondary	Minimal Residual Disease (MRD)	To assess the preliminary antitumor activity of Maplirpacept. Multiple myeloma participants achieved complete response will be assessed for MRD status per IMWG MRD criteria.	Baseline to measured progressive disease, up to 18 months

External Links

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