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PSB202 in Patients With Previously Treated-, Relapsed-, Indolent B-Cell Malignancies

NCT05003141 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2022-03-28

No results posted yet for this study

Summary

Product: PSB202 is a novel biological entity consisting of two engineered monoclonal antibodies, an Fc-enhanced humanized type II anti-CD20 IgG1 (PSB102) and a humanized anti-CD37 IgG1 (PSB107), that target B-cells. PSB202 is manufactured to work as a single product with the two components of PSB202 enabling a distinct dual target-specific antibody directed cell killing of B-cells.

Study: Multi-center-, International Phase 1a/1b (Escalation/Expansion) study in patients with indolent-, relapsed-, B-cell malignancies. The Phase 1a (Dose Escalation) part of study follows a 3+3 design.

Conditions

Interventions

DRUG

PSB202

PSB202 is an antibody combination product comprised of two full-length monoclonal antibodies, PSB102 and PSB 107, respectively targeting CD20 and CD37. PSB202 is manufactured to work as a single product.

Sponsors & Collaborators

  • Qilu Puget Sound Biotherapeutics (dba Sound Biologics)

    lead INDUSTRY

Principal Investigators

  • Lindsey E. Roeker, MD · Memorial Sloan-Kettering Cancer Center, New York, NY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2023-07-31
Completion
2024-01-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05003141 on ClinicalTrials.gov