LymphomaPhase 1NCT05567887
A Study to Learn About the Study Medicine (Called Maplirpacept (PF-07901801)) in Japanese With Hematologic Malignancies
A Phase 1 study testing maplirpacept (PF-07901801) in people with Lymphoma and Multiple Myeloma, run by Pfizer at 4 sites in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Multiple Myeloma
- What is being tested?
- maplirpacept (PF-07901801)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 4 sitesJapan
- Study dates
- 2 Nov 2022to 2 Oct 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
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Japanese Foundation for Cancer Research
Koto, Tokyo, 135-8550
The Cancer Institute Hospital of JFCR
Koto, Tokyo, 135-8550
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi-ken, 466-8650
Yamagata University Hospital
Yamagata, 990-9585
About this study
Official title: A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TTI-622 (PF-07901801), A SINGLE AGENT IN JAPANESE PARTICIPANTS WITH RELAPSED OR REFRACTORY LYMPHOMA
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:
Read more
- 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.
Read the 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
- Being tested
- maplirpacept (PF-07901801)
- Keywords
- Lymphoma, multiple myeloma, maplirpacept, TTI-622, PF-07901801, C4971009, Phase 1, Japan
- Medical subject headings
- Lymphoma, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maplirpacept (PF-07901801)Drug
Also called TTI-622
maplirpacept (PF-07901801)
| Study group | Role | What they receive |
|---|---|---|
| maplirpacept (PF-07901801) | Experimental | maplirpacept (PF-07901801) Receives: Drug: maplirpacept (PF-07901801) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose Limiting Toxicity (DLT) in lymphoma
Number of participants with DLTs
Measured: up to 21 days
Secondary outcomes (31)
Number of adverse events as characterized by type
overall safety profile of maplirpacept (PF-07901801)
Measured: Through study completion, up to 18 months
Number of adverse events as characterized by frequency
overall safety profile of maplirpacept (PF-07901801)
Measured: Through study completion, up to 18 months
Number of adverse events as characterized by severity
overall safety profile of maplirpacept (PF-07901801)
Measured: Through study completion, up to 18 months
Number of adverse events as characterized by timing
overall safety profile of maplirpacept (PF-07901801)
Measured: Through study completion, up to 18 months
Number of adverse events as characterized by relationship to maplirpacept (PF-07901801)
overall safety profile of maplirpacept (PF-07901801)
Measured: Through study completion, up to 18 months
Number of adverse events as characterized by seriousness
overall safety profile of maplirpacept (PF-07901801)
Measured: Through study completion, up to 18 months
Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by type
overall safety profile of maplirpacept (PF-07901801)
Measured: Through study completion, up to 18 months
Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by frequency
overall safety profile of maplirpacept (PF-07901801)
Measured: Through study completion, up to 18 months
Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by severity
overall safety profile of maplirpacept (PF-07901801)
Measured: Through study completion, up to 18 months
Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by timing
overall safety profile of maplirpacept (PF-07901801)
Measured: Through study completion, up to 18 months
Number of participants with severe thrombocytopenia and anemia in R/R multiple myeloma
overll safety profile of maplirpacept (PF-07901801)
Measured: Through study completion, up to 18 monghs
maximum observed concentration, steady state (ss) of maplirpacept (PF-07901801)
pharmacokinetics of maplirpacept (PF-07901801)
Measured: Through study completion, up to 18 months
time to maximum concentration,ss of maplirpacept (PF-07901801)
pharmacokinetics of maplirpacept (PF-07901801)
Measured: Through study completion, up to 18 months
area under the curve last,ss of maplirpacept (PF-07901801)
pharmacokinetics of maplirpacept (PF-07901801)
Measured: Through study completion, up to 18 months
area under the curve tau,ss of maplirpacept (PF-07901801)
pharmacokinetics of maplirpacept (PF-07901801)
Measured: Through study completion, up to 18 months
time to maximum concentration of maplirpacept (PF-07901801)
pharmacokinetics of maplirpacept (PF-07901801)
Measured: Through study completion, up to 18 months
trough concentration of maplirpacept (PF-07901801)
pharmacokinetics of maplirpacept (PF-07901801)
Measured: Through study completion, up to 18 months
area under the curve last of maplirpacept (PF-07901801)
pharmacokinetics of maplirpacept (PF-07901801)
Measured: Through study completion, up to 18 months
clearance of maplirpacept (PF-07901801)
pharmacokinetics of maplirpacept (PF-07901801)
Measured: Through study completion, up to 18 months
area under the curve tau of maplirpacept (PF-07901801)
pharmacokinetics of maplirpacept (PF-07901801)
Measured: Through study completion, up to 18 months
volume of distribution at steady-state of maplirpacept (PF-07901801)
pharmacokinetics of maplirpacept (PF-07901801)
Measured: Through study completion, up to 18 months
area under the curve tau,ss/area under the curve tau,sd of maplirpacept (PF-07901801)
pharmacokinetics of maplirpacept (PF-07901801)
Measured: Through study completion, up to 18 months
area under the curve inf of maplirpacept (PF-07901801)
pharmacokinetics of maplirpacept (PF-07901801)
Measured: Through study completion, up to 18 months
terminal elimination half-life off maplirpacept (PF-07901801)
pharmacokinetics of maplirpacept (PF-07901801)
Measured: Through study completion, up to 18 months
maximum observed concentration of maplirpacept (PF-07901801)
pharmacokinetics of maplirpacept (PF-07901801)
Measured: Through study completion, up to 18 months
Incidence and titers of anti-drug antibodies against maplirpacept (PF-07901801)
immunogenicity of maplirpacept (PF-07901801)
Measured: Through study completion, up to 18 months
Incidence and titers of neutralizing antibodies against maplirpacept (PF-07901801)
immunogenicity of maplirpacept (PF-07901801)
Measured: Through study completion, up to 18 months
overall response rate
preliminary antitumor activity of maplirpacept (PF-07901801)
Measured: From date of registration until the date of first documented progression or date of death from any cause, cause, whichever comes first, assessed up to 18 months
progression free survival
preliminary antitumor activity of maplirpacept (PF-07901801)
Measured: From date of registration until the date of first documented progression or date of death from any cause, cause, whichever comes first, assessed up to 18 months
time to response
preliminary antitumor activity of maplirpacept (PF-07901801)
Measured: From date of registration until the date of first documented progression or date of death from any cause, cause, whichever comes first, assessed up to 18 months
duration of response
preliminary antitumor activity of maplirpacept (PF-07901801)
Measured: From date of registration until the date of first documented progression or date of death from any cause, cause, whichever comes first, assessed 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.
- First posted5 Oct 2022
- Study start2 Nov 2022
- Primary completion2 Oct 2024
- Study completion2 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Sequential
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567887
- Sponsor's protocol ID
- C4971009
- Status last verified
- Nov 2024
- First submitted
- 22 Sep 2022
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TTI-622 (PF-07901801), A SINGLE AGENT IN JAPANESE PARTICIPANTS WITH RELAPSED OR REFRACTORY LYMPHOMA
- ClinicalTrials.gov ID
- NCT05567887
- Acronym / sponsor ID
- C4971009
- Conditions
- Lymphoma, Multiple Myeloma
- Keywords
- Lymphoma, multiple myeloma, maplirpacept, TTI-622, PF-07901801, C4971009, Phase 1, Japan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 2 Oct 2024 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| maplirpacept (PF-07901801) | Experimental | Drug: maplirpacept (PF-07901801)maplirpacept (PF-07901801) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| maplirpacept (PF-07901801)Also: TTI-622maplirpacept (PF-07901801) | Drug | maplirpacept (PF-07901801) |
Primary outcome
Number of Participants with Dose Limiting Toxicity (DLT) in lymphoma
Time frame: up to 21 days
Number of participants with DLTs
31 secondary outcomes
Number of adverse events as characterized by type
Time frame: Through study completion, up to 18 months
Number of adverse events as characterized by frequency
Time frame: Through study completion, up to 18 months
Number of adverse events as characterized by severity
Time frame: Through study completion, up to 18 months
Number of adverse events as characterized by timing
Time frame: Through study completion, up to 18 months
Number of adverse events as characterized by relationship to maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
Number of adverse events as characterized by seriousness
Time frame: Through study completion, up to 18 months
Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by type
Time frame: Through study completion, up to 18 months
Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by frequency
Time frame: Through study completion, up to 18 months
Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by severity
Time frame: Through study completion, up to 18 months
Number of participants with clinically significant change from baseline in laboratory abnormalities as characterized by timing
Time frame: Through study completion, up to 18 months
Number of participants with severe thrombocytopenia and anemia in R/R multiple myeloma
Time frame: Through study completion, up to 18 monghs
maximum observed concentration, steady state (ss) of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
time to maximum concentration,ss of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
area under the curve last,ss of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
area under the curve tau,ss of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
time to maximum concentration of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
trough concentration of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
area under the curve last of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
clearance of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
area under the curve tau of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
volume of distribution at steady-state of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
area under the curve tau,ss/area under the curve tau,sd of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
area under the curve inf of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
terminal elimination half-life off maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
maximum observed concentration of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
Incidence and titers of anti-drug antibodies against maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
Incidence and titers of neutralizing antibodies against maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
overall response rate
Time frame: From date of registration until the date of first documented progression or date of death from any cause, cause, whichever comes first, assessed up to 18 months
progression free survival
Time frame: From date of registration until the date of first documented progression or date of death from any cause, cause, whichever comes first, assessed up to 18 months
time to response
Time frame: From date of registration until the date of first documented progression or date of death from any cause, cause, whichever comes first, assessed up to 18 months
duration of response
Time frame: From date of registration until the date of first documented progression or date of death from any cause, cause, whichever comes first, assessed up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing maplirpacept (PF-07901801) in people with Lymphoma and Multiple Myeloma, run by Pfizer at 4 sites in Japan.
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 6 inclusion and 13 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 6 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 4 sites in Japan. 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) in lymphoma (time frame: up to 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2024.