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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.
- Marginal Zone Lymphoma
- Non-Hodgkin's Lymphoma
- MALT Lymphoma
- Chronic Lymphocytic Leukemia
- Mantle Cell Lymphoma
- Waldenstrom Macroglobulinemia
- Follicular Lymphoma
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
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Who is running the clinical trial?
- 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.
- Group 1: Single-arm, escalating dose levels
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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