A Study of AZD0486 in Subjects With B-Cell Non-Hodgkin Lymphoma

Part of paid clinical trials in Tampa, Florida.

Sponsor
AstraZeneca
Study ID
NCT04594642
Phase
PHASE1
Status
Recruiting
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Conditions

  • B-cell Non Hodgkin Lymphoma
  • Diffuse Large B Cell Lymphoma
  • Follicular Lymphoma
  • High-grade B-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • AZD0486 IV — DRUG
    AZD0486 is a bispecific antibody targeting CD19 on tumor cells and CD3 on T-cells leading to T cell-mediated cytotoxicity of malignant B cells

Study Details

This phase 1 study will investigate the safety, tolerability, pharmacokinetic, pharmacodynamic, and clinical activity of AZD0486, a CD19 x CD3 T-cell engaging bispecific antibody, in subjects with B-cell non-Hodgkin lymphoma (B-NHL).

Key Dates

Start date
Mar 2, 2021
Status verified
Apr 2026
Primary completion
Apr 19, 2028
Completion
Apr 19, 2028

Study Design

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

Arms

  • Experimental: AZD0486 Monotherapy Dose Escalation in Subjects with B-NHL
    AZD0486 monotherapy will be administered intravenously on day 1 and 15 of 28 day cycles for a maximum of 2 years or until discontinuation criteria are met. Depending on cohort, subjects may receive priming or step-up dosing administered weekly during cycle 1 before reaching the target dose. Additional cohorts may be opened where subjects receive weekly dosing during Cycles 1-2. While on study, subjects will be monitored for safety and efficacy with periodic disease assessment with PET/CT. If subject achieves two consecutive CRs after completing C6, then they may be eligible for monthly dosing

Primary Outcome Measure

Incidence of subjects with Dose-limiting toxicities (DLT) [ Time Frame: 28 days ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Research SiteTampaFlorida33612-
Research SiteLouisvilleKentucky40207-
Research SiteNew BrunswickNew Jersey08901-
Research SiteCharlotteNorth Carolina28204-
Research SiteColumbusOhio43210-
Research SitePortlandOregon97239-
Research SitePittsburghPennsylvania15237-
Research SiteAustinTexas78704-
Research SiteHoustonTexas77030-
Research SiteMilwaukeeWisconsin53226-

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