A Study to Evaluate Safety, PK, PD and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With R/R B-Cell Malignancies.

Part of paid clinical trials in La Jolla, California.

Sponsor
AstraZeneca
Study ID
NCT06542250
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • B-cell Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AZD5492 — DRUG
    CD8/TCR based T-cell engaging antibody targeting CD20, which is administered subcutaneously

Study Details

This is a Phase I/II study designed to evaluate if experimental T cell engaging antibody targeting CD20 AZD5492 is safe, tolerable and efficacious in participants with Relapsed or Refractory B-Cell Malignancies.

Key Dates

Start date
Sep 18, 2024
Status verified
Apr 2026
Primary completion
Feb 14, 2028
Completion
Feb 14, 2028

Study Design

Enrollment
174 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Module 1: AZD5492 Monotherapy
    AZD5492 monotherapy for Relapsed or Refractory B-Cell Malignancies.

Primary Outcome Measure

Frequency of dose limiting toxicities (DLTs). [ Time Frame: Module 1 - From the first administration of AZD5492 until the end of cycle 1 (up to 5 weeks). ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Research SiteLa JollaCalifornia92093-
Research SiteBostonMassachusetts02215-
Research SiteRochesterMinnesota55905-
Research SiteHackensackNew Jersey07601-
Research SiteNew YorkNew York10021-
Research SiteNew YorkNew York10029-
Research SiteCharlotteNorth Carolina28203-
Research SiteWinston-SalemNorth Carolina27157-
Research SiteHoustonTexas77030-
Research SiteSeattleWashington98109-

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