A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of AZD0486, a Bispecific Antibody Targeting CD19 in Subjects With B-Cell Non-Hodgkin Lymphoma

Who is this study for? Adult patients with relapsed or refractory b-cell non-Hodgkin's lymphoma
What treatments are being studied? TNB-486
Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 130
Healthy Volunteers: f
View:

• Biopsy proven B-NHL, including DLBCL, HGBL, or FL.

• Relapsed/refractory cohorts:

⁃ In order to be eligible subjects must have received at least 2 prior lines of therapy and not be candidates for treatment regimens known to provide clinical benefit in B-NHL. CAR T-naive subjects are allowed if they have declined, are considered ineligible for, or do not have timely access to CAR T cell therapies.

• 1L FL cohorts: Subject has biopsy-proven FL Grade 1-3a per WHO 2016 classification, Stage II-IV, FL International Prognostic Index 2-5 that has not been treated with prior systemic lymphoma-directed therapy and requires initiation of treatment based on GELF criteria. Radiation to localized disease prior to study entry is allowed if \>14 days from first dose.

• All Cohorts:

⁃ Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.

• Subject must have adequate liver, bone marrow and kidney function (eGFR ≥ 50 mL/min).

• Subject must have locally confirmed CD19 positivity (must be documented after time of progression from last CD19-targeted therapy, if received)

• Subject must have at least 1 measurable disease site

• Subject must have ANC \>/= 1000/mm3, platelets \>/= 50,000 mm3, hemoglobin \>/= 8.0 g/dL. Transfusion and/or growth factor are allowed but counts must be stable for at least 72 hours afterwards prior to screening

• Subject must have a total bilirubin \<1.5x ULN, AST/ALT \< 3xULN

Locations
United States
Florida
Research Site
RECRUITING
Tampa
Kentucky
Research Site
RECRUITING
Louisville
North Carolina
Research Site
RECRUITING
Charlotte
New Jersey
Research Site
RECRUITING
New Brunswick
Ohio
Research Site
RECRUITING
Columbus
Oregon
Research Site
WITHDRAWN
Portland
Pennsylvania
Research Site
RECRUITING
Pittsburgh
Texas
Research Site
RECRUITING
Austin
Research Site
RECRUITING
Houston
Wisconsin
Research Site
RECRUITING
Milwaukee
Other Locations
Australia
Research Site
NOT_YET_RECRUITING
Bedford Park
Research Site
RECRUITING
Heidelberg
Research Site
RECRUITING
Hobart
Research Site
RECRUITING
Melbourne
Japan
Research Site
RECRUITING
Chūōku
Research Site
RECRUITING
Kōtoku
Research Site
RECRUITING
Nagoya
Research Site
RECRUITING
Yamagata
Republic of Korea
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Taiwan
Research Site
RECRUITING
Kaohsiung City
Research Site
RECRUITING
Kweishan
Research Site
RECRUITING
Tainan City
Research Site
RECRUITING
Taipei
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2021-03-02
Estimated Completion Date: 2028-04-19
Participants
Target number of participants: 317
Treatments
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
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov

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