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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Phase 1a (dose escalation): Relapsed/refractory following at least 2 prior lines of standard of care treatment. Prior treatments received must be documented on the enrollment request form. For FL, prior treatment must have included at least 1 rituximab containing regimen
Phase 1a (dose escalation): In the opinion of the investigator, able to tolerate potentially subtherapeutic doses of PSB202 for the duration of a 28-day DLT observation window
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up2 months
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Marginal Zone Lymphoma
- Non-Hodgkin's Lymphoma
- MALT Lymphoma
- Chronic Lymphocytic Leukemia
- Mantle Cell Lymphoma
- Waldenstrom Macroglobulinemia
- Follicular Lymphoma
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have relapsed or refractory cancer after trying at least two standard treatments. If you have follicular lymphoma, you must have received at least one treatment that includes rituximab.
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You are able to handle possibly lower doses of PSB202 for a 28-day period as decided by the doctor.
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You have a confirmed presence of CD20 protein on your cells. If CD37 protein information is not available from your medical records, it can be checked using a new or stored blood sample after you join the study.
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People with certain types of slow-growing non-Hodgkin lymphoma (NHL) who have not responded well to at least two standard treatments may be included. If you have follicular NHL, you must have been treated with rituximab before, and if you have mantle cell lymphoma (MCL), you must have been treated with a certain type of medication before.
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You have a level of ability to care for yourself and do daily activities that falls between very good and needing some help.
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You must have stopped taking any anti-CD20 antibody therapy at least 4 weeks before starting PSB202.
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If you had COVID-19 in the last 6 months, you need to test negative for COVID-19 with a PCR test within 7 days before joining the study.
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You must be at least 18 years old to participate in the study, and there is no maximum age limit.
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You must wait four weeks after any previous cancer treatment before joining the study. But if stopping treatment could cause serious problems, and you have approval from the medical monitor, you might still be able to join the study.
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Your blood and clotting abilities are at the right levels before starting treatment.
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Your liver is working properly.
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You have a type of slow-growing blood cancer called NHL, CLL, or WM, and have not responded well to standard treatments.
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Your kidneys are working well, with an estimated filtration rate of at least 50 milliliters per minute.
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 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.
Find a Location
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
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Only for phase 1a (dose escalation): Participants with bulky NHL, which means they have a mass that is 10 centimeters or longer.You had a major surgery within 4 weeks before the study starts.You have had radiation therapy for pain relief within 7 days before starting the study treatment, unless the radiation was to a large part of the bone marrow or the whole brain, in which case it must have been completed at least 4 weeks before starting the study treatment.You have lymphoma that has spread to your central nervous system (brain and spinal cord). If you have been treated for this and are stable without signs of active disease, you may still be eligible with approval from the doctor and sponsor.You have an ongoing autoimmune condition causing low blood cell counts.You have a serious ongoing infection or another health issue that makes it risky for you to take part in the trial.If you have HIV, you cannot participate in the study. If your HIV status is unknown, you will be tested for HIV before joining the study.You have relapsed or refractory cancer after trying at least two standard treatments. If you have follicular lymphoma, you must have received at least one treatment that includes rituximab.You are able to handle possibly lower doses of PSB202 for a 28-day period as decided by the doctor.You have a specific autoimmune condition or have been treated for an autoimmune condition within the last 2 years.You can continue certain standard cancer treatments, like hormonal therapy for breast and prostate cancer, and growth factor support after a specific period.You have side effects from previous treatments that are not fully resolved and are Grade 2 or higher, except for hair loss.You had a stem cell transplant or CAR-T therapy in the last 180 days.You have had a stroke, heart attack, unstable angina, or severe heart failure within the past 6 months, or have had certain heart rhythm problems within the past 3 months. Your heart's electrical activity (measured by ECG) is outside of the normal range.People with certain types of slow-growing non-Hodgkin lymphoma (NHL) who have not responded well to at least two standard treatments may be included. If you have follicular NHL, you must have been treated with rituximab before, and if you have mantle cell lymphoma (MCL), you must have been treated with a certain type of medication before.You have a level of ability to care for yourself and do daily activities that falls between very good and needing some help.You must have stopped taking any anti-CD20 antibody therapy at least 4 weeks before starting PSB202.If you had COVID-19 in the last 6 months, you need to test negative for COVID-19 with a PCR test within 7 days before joining the study.You must be at least 18 years old to participate in the study, and there is no maximum age limit.You must wait four weeks after any previous cancer treatment before joining the study. But if stopping treatment could cause serious problems, and you have approval from the medical monitor, you might still be able to join the study.Your liver is working properly.You have active graft versus host disease or are currently taking medication to suppress your immune system.You have an active viral hepatitis infection, or have a history of hepatitis C and have not received successful treatment.You have a history of liver damage caused by medication or cirrhosis.You have a type of slow-growing blood cancer called NHL, CLL, or WM, and have not responded well to standard treatments.Your kidneys are working well, with an estimated filtration rate of at least 50 milliliters per minute.You have a confirmed presence of CD20 protein on your cells. If CD37 protein information is not available from your medical records, it can be checked using a new or stored blood sample after you join the study.Your blood and clotting abilities are at the right levels before starting treatment.You have had a lung disease called pneumonitis or interstitial lung disease in the past.
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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