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NCT05003141 : A Phase 1a/1b Study of PSB202 in Patients With Previously Treated-, Relapsed-, Indolent B-Cell Malignancies

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaB-Cell Non Hodgkin Lymphoma,Chronic Lymphocytic Leukaemia,Follicular Lymphoma,Leukaemia,Lymphoma,Mantle Cell Lymphoma

Trial Overview Read MoreRead more

This Phase I study is trying to understand the recommended dose, safety and effective of a new targeted therapy (PSB202) in people with previously treated B-cell cancers.
 

This trial is treating patients with Follicular Lymphoma, Marginal Zone Lymphoma, Small Lymphocytic Lymphoma, Waldenstrom Macroglobulinaemia, and Chronic Lymphocytic Leukaemia.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase 1a/1b Study of PSB202 in Patients With Previously Treated-, Relapsed-, Indolent B-Cell Malignancies

Commercial Sponsor

Qilu Puget Sound Biotherapeutics (dba Sound Biologics)

Summary

This trial has two phases and is trialling a new therapy in patients with indolent-, relapsed-, CD20+ and CD37+ expressing B-cell malignancies. Phase 1a is a 3+3 dose escalation design where participants will receive PSB202 in ascending dose levels. Phase 1b is focusing on dose expansion and follows a Simon's Two-Stage design. Phase 1b enrols up to 20 patients in each of one of three disease-specific cohorts: (1) follicular lymphoma; (2) chronic lymphocytic leukaemia and small lymphocytic lymphoma; (3) a mixed indolent B-cell histology cohort comprising Waldenstrom Macroglobulinemia, indolent phenotype Mantle Cell Lymphoma, and Marginal Zone Lymphoma.

Recruiting Hospitals Read MoreRead more

Epworth Hospital Haematology
East Melbourne
Dr Connie Barlas
connie.barlas@epworth.org.au
03 9516 2374

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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