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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
Study Summary
This trial is testing a new two-part drug called PSB202 to see if it is safe and effective in treating patients with B-cell malignancies.
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.Check my eligibility
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).See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events
Dose Limiting Toxicity (DLT)
Secondary outcome measures
Area under the Plasma Concentration versus Time Curve (AUC)
Change in CD20+ cell counts
Number of Patients with measurable Anti-Lymphoma Response
+1 moreTrial 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.
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can PSB202 be reliably consumed without adverse effects?
"Due to the early phase of clinical trials, PSB202 was assigned a score of 1 with regards to safety. Thus far there is only limited data supporting its efficacy and any potential harms."
Answered by AI
What aims does this clinical experiment endeavor to attain?
"According to the trial's sponsor, Qilu Puget Sound Biotherapeutics (dba Sound Biologics), Adverse Events are the primary outcomes being monitored over a three-week period. Additionally, secondary objectives like International Working Group Criteria for NHL and Hallek Criteria for CLL will be assessed along with Plasma Concentration versus Time Curve AUCs and Peak Plasma Concentrations of PSB202 components PSB102 and PSB107."
Answered by AI
What is the total enrollment capacity for this research initiative?
"True, the clinicaltrial.gov listing confirms that recruitment is presently underway for this trial which was originally posted on November 15th 2021 and updated most recently on March 11th 2022. The investigators need to recruit a total of 110 individuals across two sites."
Answered by AI
Are there still opportunities for potential participants to join this research endeavor?
"As per the clinicaltrials.gov post, this trial is presently in search of test subjects. It was first made available to the public on November 15th 2021 and has been recently updated 11 March 2022."
Answered by AI
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