maplirpacept (PF-07901801)
Drugmaplirpacept (PF-07901801)
Other names: TTI-622
NCT Number: NCT05567887
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 1
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Aichi-ken, Japan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
maplirpacept (PF-07901801)
Other names: TTI-622
Time frame: up to 21 days
Number of participants with DLTs
Time frame: Through study completion, up to 18 months
overall safety profile of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
overall safety profile of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
overall safety profile of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
overall safety profile of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
overall safety profile of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
overall safety profile of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
overall safety profile of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
overall safety profile of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
overall safety profile of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
overall safety profile of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 monghs
overll safety profile of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
pharmacokinetics of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
pharmacokinetics of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
pharmacokinetics of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
pharmacokinetics of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
pharmacokinetics of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
pharmacokinetics of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
pharmacokinetics of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
pharmacokinetics of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
pharmacokinetics of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
pharmacokinetics of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
pharmacokinetics of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
pharmacokinetics of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
pharmacokinetics of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
pharmacokinetics of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
immunogenicity of maplirpacept (PF-07901801)
Time frame: Through study completion, up to 18 months
immunogenicity of maplirpacept (PF-07901801)
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
preliminary antitumor activity of maplirpacept (PF-07901801)
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
preliminary antitumor activity of maplirpacept (PF-07901801)
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
preliminary antitumor activity of maplirpacept (PF-07901801)
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
preliminary antitumor activity of maplirpacept (PF-07901801)
Pfizer
Industry
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
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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