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Completed

NCT Number: NCT05896774

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

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.

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Key information

Conditions

Non-Hodgkin Lymphoma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Cancer Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Maplirpacept

Drug

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

Other names: PF-07901801, TTI-622

Primary outcomes

  1. Number of Participants With Dose-Limiting Toxicity (DLT)

    Time frame: Cycle 1：up to 21 days

    Part A only. To characterize the dose limiting toxicities (DLTs) of Maplirpacept.

  2. Single-dose Cmax

    Time frame: 0, 1, 2, 4, 24, 72 hours post-dose up to Day 8

    Maximum Observed Plasma Concentration

  3. Single-dose AUClast

    Time frame: 0, 1, 2, 4, 24, 72 hours post-dose up to Day 8

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  4. Single-dose AUCtau

    Time frame: 0, 1, 2, 4, 24, 72 hours post-dose up to Day 8

    Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 1 week.

Secondary outcomes

  1. 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

    Time frame: Baseline up to 28 days after the last dose of study drug

    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.

  2. 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

    Time frame: Baseline up to 28 days after the last dose of study drug

    Laboratory parameters included: hematology, blood chemistry and coagulation. Clinical significance of laboratory parameters was determined at the investigator's discretion.

  3. Single-dose Tmax (Time to Reach Maximum Observed Plasma Concentration)

    Time frame: 0, 1, 2, 4, 24, 72 hours post-dose up to Day8

    Pharmacokinetics of Maplirpacept

  4. Multiple-dose Cmax (Maximum Observed Plasma Concentration)

    Time frame: Through study completion, up to 18 months

    Pharmacokinetics of Maplirpacept

  5. Multiple-dose Ctrough (trough concentration)

    Time frame: Through study completion, up to 18 months

    Pharmacokinetics of Maplirpacept

  6. Multiple-dose Cmin (Minimum Observed Plasma Trough Concentration)

    Time frame: Through study completion, up to 18 months

    Pharmacokinetics of Maplirpacept

  7. Multiple-dose Tmax (Time to Reach Maximum Observed Plasma Concentration)

    Time frame: Through study completion, up to 18 months

    Pharmacokinetics of Maplirpacept

  8. Multiple-dose AUClast (Area under the plasma concentration time-curve from zero to the last measured concentration)

    Time frame: Through study completion, up to 18 months

    Pharmacokinetics of Maplirpacept

  9. Multiple-dose AUCtau (Area Under the Curve from Time Zero to end of dosing interval)

    Time frame: Through study completion, up to 18 months

    Pharmacokinetics of Maplirpacept

  10. Multiple-dose Rac (Accumulation Ratio)

    Time frame: Through study completion, up to 18 months

    Pharmacokinetics of Maplirpacept

  11. CL (Systemic Clearance)

    Time frame: Through study completion, up to 18 months

    Pharmacokinetics of Maplirpacept

  12. Vss (Volume of Distribution at Steady State)

    Time frame: Through study completion, up to 18 months

    Pharmacokinetics of Maplirpacept

  13. t½ (Plasma Decay Half-Life)

    Time frame: Through study completion, up to 18 months

    Pharmacokinetics of Maplirpacept

  14. AUCinf (Area Under the Curve From Time Zero to Extrapolated Infinite Time)

    Time frame: Through study completion, up to 18 months

    Pharmacokinetics of Maplirpacept

  15. Incidence and titers of anti-drug antibodies against TTI-622

    Time frame: Through study completion, up to 18 months

    Pharmacokinetics of Maplirpacept

  16. Incidence and titers of neutralizing antibodies against TTI-622

    Time frame: Through study completion, up to 18 months

    Pharmacokinetics of Maplirpacept

  17. Objective Response

    Time frame: Baseline to measured progressive disease, up to 18 months

    To assess the preliminary antitumor activity of Maplirpacept

  18. Time to Tumor Response (TTR)

    Time frame: Baseline to measured progressive disease, up to 18 months

    To assess the preliminary antitumor activity of Maplirpacept

  19. Duration of Response (DOR)

    Time frame: Baseline to measured progressive disease, up to 18 months

    To assess the preliminary antitumor activity of Maplirpacept

  20. Progression-Free Survival (PFS)

    Time frame: Baseline to measured progressive disease, up to 18 months

    To assess the preliminary antitumor activity of Maplirpacept

  21. Minimal Residual Disease (MRD)

    Time frame: Baseline to measured progressive disease, up to 18 months

    To assess the preliminary antitumor activity of Maplirpacept. Multiple myeloma participants achieved complete response will be assessed for MRD status per IMWG MRD criteria.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 9, 2023
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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