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Monoclonal Antibodies

PSB202 for B-Cell Malignancies

Memorial Sloan-Kettering Cancer Center, New York, NY
Targeting 8 different conditionsPSB202Phase 1RecruitingResearch Sponsored by Qilu Puget Sound Biotherapeutics (dba Sound Biologics)

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 below
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 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.
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 blood and clotting abilities are at the right levels before starting treatment.
Your liver is working properly.
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.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months for reporting.

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 more

Awards & 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

PSB202 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05003141 — Phase 1
Marginal Zone Lymphoma Research Study Groups: Single-arm, escalating dose levels
Marginal Zone Lymphoma Clinical Trial 2023: PSB202 Highlights & Side Effects. Trial Name: NCT05003141 — Phase 1
PSB202 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05003141 — Phase 1

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
~37 spots leftby Nov 2024