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Non-Hodgkin LymphomaPhase 1NCT05896774

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

A Phase 1 study testing Maplirpacept in people with Non-Hodgkin Lymphoma and Multiple Myeloma, run by Pfizer at 5 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Hodgkin Lymphoma, Multiple Myeloma
What is being tested?
Maplirpacept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
5 sitesChina
Study dates
28 Jun 2023to 6 Nov 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang, 310016

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

Other trials in China

About this study

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

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).

Read more

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.

Read the 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).

Being tested
Maplirpacept
Medical subject headings
Lymphoma, Non-Hodgkin, Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MaplirpaceptDrug

    Also called PF-07901801, TTI-622

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

Study groups in NCT05896774
Study groupRoleWhat they receive
Maplirpacept (PF-07901801)Experimentalsingle arm study
Receives: Drug: Maplirpacept

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Cycle 1：up to 21 days

  2. Single-dose Cmax

    Maximum Observed Plasma Concentration

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

  3. Single-dose AUClast

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

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

  4. Single-dose AUCtau

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

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

Secondary outcomes (21)

  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

    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.

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

  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

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

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

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

    Pharmacokinetics of Maplirpacept

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

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

    Pharmacokinetics of Maplirpacept

    Measured: Through study completion, up to 18 months

  5. Multiple-dose Ctrough (trough concentration)

    Pharmacokinetics of Maplirpacept

    Measured: Through study completion, up to 18 months

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

    Pharmacokinetics of Maplirpacept

    Measured: Through study completion, up to 18 months

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

    Pharmacokinetics of Maplirpacept

    Measured: Through study completion, up to 18 months

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

    Pharmacokinetics of Maplirpacept

    Measured: Through study completion, up to 18 months

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

    Pharmacokinetics of Maplirpacept

    Measured: Through study completion, up to 18 months

  10. Multiple-dose Rac (Accumulation Ratio)

    Pharmacokinetics of Maplirpacept

    Measured: Through study completion, up to 18 months

  11. CL (Systemic Clearance)

    Pharmacokinetics of Maplirpacept

    Measured: Through study completion, up to 18 months

  12. Vss (Volume of Distribution at Steady State)

    Pharmacokinetics of Maplirpacept

    Measured: Through study completion, up to 18 months

  13. t½ (Plasma Decay Half-Life)

    Pharmacokinetics of Maplirpacept

    Measured: Through study completion, up to 18 months

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

    Pharmacokinetics of Maplirpacept

    Measured: Through study completion, up to 18 months

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

    Pharmacokinetics of Maplirpacept

    Measured: Through study completion, up to 18 months

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

    Pharmacokinetics of Maplirpacept

    Measured: Through study completion, up to 18 months

  17. Objective Response

    To assess the preliminary antitumor activity of Maplirpacept

    Measured: Baseline to measured progressive disease, up to 18 months

  18. Time to Tumor Response (TTR)

    To assess the preliminary antitumor activity of Maplirpacept

    Measured: Baseline to measured progressive disease, up to 18 months

  19. Duration of Response (DOR)

    To assess the preliminary antitumor activity of Maplirpacept

    Measured: Baseline to measured progressive disease, up to 18 months

  20. Progression-Free Survival (PFS)

    To assess the preliminary antitumor activity of Maplirpacept

    Measured: Baseline to measured progressive disease, up to 18 months

  21. 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.

    Measured: Baseline to measured progressive disease, up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2023
  2. Study start28 Jun 2023
  3. Primary completion6 Nov 2024
  4. Study completion6 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05896774
Sponsor's protocol ID
C4971010
Status last verified
Nov 2024
First submitted
31 May 2023
Last updated
20 Nov 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Maplirpacept in people with Non-Hodgkin Lymphoma and Multiple Myeloma, run by Pfizer at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Dose-Limiting Toxicity (DLT) (time frame: Cycle 1：up to 21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05896774.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024; AzTrials last refreshed its copy on 30 Oct 2026.

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