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Monoclonal Antibodies
PSB202 for B-Cell Lymphoma
Phase 1
Waitlist Available
Research Sponsored by Qilu Puget Sound Biotherapeutics (dba Sound Biologics)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests PSB202, a new treatment made of two special proteins, in patients with slow-growing or returning blood cancers. The treatment helps the immune system target and destroy cancer cells by attaching to specific markers on them. These special proteins have been developed over the last two decades as a promising approach for cancer therapy.
Who is the study for?
Adults with certain types of B-cell malignancies like lymphoma or leukemia, who have relapsed after standard treatments. They must be over 18, not pregnant, and without serious health conditions that could affect trial participation. Participants need to have recovered from previous therapies and agree to use effective birth control.
What is being tested?
PSB202 is being tested; it's a new therapy combining two engineered antibodies targeting B-cells. The study has two parts: Phase 1a tests different doses to find the safest one (dose escalation), and Phase 1b gives the best dose found in Phase 1a to more people (dose expansion).
What are the potential side effects?
Potential side effects are not specified but may include reactions related to immune system activation such as infusion reactions, organ inflammation, fatigue, blood disorders, or increased infection risk due to targeted cell killing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse Events
Dose Limiting Toxicity (DLT)
Secondary study objectives
Area under the Plasma Concentration versus Time Curve (AUC)
Change in CD20+ cell counts
Number of Patients with measurable Anti-Lymphoma Response
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single-arm, escalating dose levelsExperimental Treatment1 Intervention
3 + 3 Phase 1 dose escalation design; sequential ascending dose levels.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Non-Hodgkin's Lymphoma (NHL) often involve monoclonal antibodies that target specific antigens on B-cells, such as CD20 and CD37. These antibodies work by binding to the antigens, which can directly induce cell death, recruit immune cells to destroy the cancer cells, or deliver cytotoxic agents to the cancer cells.
This targeted approach is important for NHL patients as it allows for more precise treatment, potentially reducing damage to healthy cells and improving overall treatment efficacy.
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Who is running the clinical trial?
Qilu Puget Sound Biotherapeutics (dba Sound Biologics)Lead Sponsor
1 Previous Clinical Trials
64 Total Patients Enrolled
Jelle Kijlstra, MDStudy DirectorQilu Puget Sound Biotherapeutics
Lindsey E. Roeker, MDStudy ChairMemorial Sloan-Kettering Cancer Center, New York, NY
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Patients can continue certain standard cancer treatments, like hormone therapy for breast and prostate cancer, and growth factor support after a certain period.You must have stopped taking any anti-CD20 antibody therapy at least 4 weeks before starting PSB202.If you had COVID-19 within 6 months before you join the study, you need to get tested again to make sure you don't have it when you join.You must be at least 18 years old to participate, and there is no maximum age limit.You have a history of pneumonitis or interstitial lung disease.You have a history of liver damage caused by medication or cirrhosis.You have a certain type of non-Hodgkin lymphoma, chronic lymphocytic leukemia, or Waldenström macroglobulinemia that has not responded to or cannot tolerate standard treatments.You have a condition where your immune system attacks your own blood cells, like autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura.You have received radiation treatment within 7 days before starting the study, except for some specific types of radiation treatments.People who have HIV are not allowed to participate because the study drug might interact with their HIV medications and increase the risk of infections. If you don't know if you have HIV, you will be tested before joining the study.You have tried at least two standard treatments, but your disease has continued to get worse.You are able to perform everyday activities without assistance or with some restrictions.You have a serious, uncontrolled infection or other active disease that makes it not safe for you to be part of the trial.You have had a stem cell transplant or CAR-T therapy in the last six months and still have certain related health issues or are taking certain medications.Only patients with a large mass (10 cm or larger) due to non-Hodgkin's lymphoma can participate in the dose escalation phase.You had a major surgery within 4 weeks before the study starts.You currently have graft versus host disease (GVHD) or are taking medication to suppress your immune system.You have had a stem cell transplant from a donor or a special type of immune cell therapy called CAR-T in the past.If you have a specific type of advanced blood cancer, you cannot be in the first phase of the trial, and you cannot be taking any other experimental treatments at the same time.You must wait at least four weeks after any previous cancer treatment before joining the study, unless your doctor approves a shorter wait because of potential health risks.You have sufficient blood and clotting abilities before starting treatment.Your liver is working properly.You have active hepatitis B or C, as shown by positive blood tests, or need treatment for it. If you have a history of hepatitis C and have been successfully treated, you can still participate.You have an ongoing autoimmune disease or have been treated for an autoimmune disease within the last 2 years, except for certain conditions like hypothyroidism and vitiligo. If you had childhood asthma or atopy, it should not have been active in the 2 years before the study screening.You have tried at least two standard treatments that did not work for your condition, and if you have follicular lymphoma, you must have been treated with at least one regimen containing rituximab.Your kidneys are working well, with a filtration rate of at least 50 mL per minute.You have been diagnosed with a certain type of cancer that has a specific protein called CD20. If the cancer has CD37 protein, a blood test may be needed to confirm it after you join the study.You are still experiencing side effects from your previous treatment that are greater than a Grade 2 except for hair loss.You have lymphoma that has spread to your central nervous system, unless you have received treatment for it and are stable without any signs of active disease, with approval from the study sponsor.You have had a stroke, heart attack, or severe heart failure in the past 6 months, or your heart's electrical activity is abnormal.People with specific types of slow-growing lymphomas who have not responded well to at least two standard treatments can participate. If you have follicular lymphoma, you must have been treated with rituximab before. If you have mantle cell lymphoma, you must have received a certain type of medication before.
Research Study Groups:
This trial has the following groups:- Group 1: Single-arm, escalating dose levels
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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