A Study to Learn About the Study Medicine (Called TTI-622) in Japanese With Difficult to Manage Type of Lymphoma

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this clinical trial is to learn about how safe and tolerable is the study medicine (called TTI-622) when taken for the treatment of lymphoma (a type of cancer that affects your body's infection-fighting cells, lymphocytes).

This study is seeking participants who:

• are 18 years of age or older

• have worsening and difficult to manage type of lymphoma

• 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 TTI-622 as an IV infusion (given directly into a vein) at the study clinic every week.

Participants will continue to receive TTI-622 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 TTI-622, is safe and can be given to Japanese people.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

Inclusion Criteria:

• Relapsed or refractory lymphoma (Hodgkin's or non-Hodgkin's)

• 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

Exclusion Criteria:

• 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

• 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