Non Hodgkin Lymphoma Clinical Trial

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

Summary

This is a phase 1, open-label study evaluating the safety, tolerability, pharmacokinetic, pharmacodynamic, and clinical activity of TNB-486, a CD19 x CD3 T-cell engaging bispecific antibody, in subjects with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) who have received 2 or more prior lines of therapy. The study consists of 3 parts, a monotherapy dose escalation (Arm A), a monotherapy dose expansion in subjects with diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL) (Arm B), and a monotherapy dose expansion in subjects with follicular lymphoma (FL) (Arm C). Once the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is identified in Arm A, Arm B and Arm C will be initiated to further characterize the safety, tolerability and pharmacokinetic (PK) profile of the MTD/RP2D dose of TNB-486 monotherapy in subsets of subjects with DLBCL/HGBL or FL.

View Full Description

Full Description

The study consists of 3 parts. Part 1 Arm A is a dose escalation study allowing the assessment of safety, tolerability, PK and PD profiles of single-agent AZD0486.

Part 2 Arm B will evaluate the MTD (or RP2D) of AZD0486 monotherapy in subjects with biopsy proven RR DLBCL and HGBL. This will be initiated once expansion dose has been selected based on data from Part 1 Arm A.

Part 2 Arm C evaluate the MTD (or RP2D) of AZD0486 monotherapy in subjects with biopsy proven RR FL. Arm C will be initiated once the expansion dose for FL has been selected based on data from the Monotherapy Dose Escalation (Part 1, Arm A).

The expansion dose and dosing frequency for Part 2 will be chosen by the SMG based on safety, tolerability, and PK/PD data collected during the dose escalation portion of the study.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Biopsy proven B-NHL, including DLBCL, HGBL, or FL.
For Arm B Only: Subject has biopsy proven DLBCL or HGBL
For Arm C only: Subject has biopsy proven FL
Subject has received at least 2 lines of therapy to which the subject has been either refractory or has subsequently relapsed. In order to be eligible for this study subjects must not be candidates for treatment regimens known to provide clinical benefit in B-NHL.
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

Exclusion Criteria:

Subject has been diagnosed with or treated for another malignancy whose natural history or treatment may interfere with the safety or efficacy assessment of the investigational regimen.
Subject has a history of central nervous system (CNS) involvement by their B-NHL
Subject has a history of leukemic presentation of their B-NHL.
Subject has history or presence of clinically significant CNS pathology
Subject has CNS involvement from active or history of autoimmune disease.
Subject experienced Grade ≥ 3 cytokine release syndrome (CRS) following prior T-cell engager (TCE) or CAR T-cell therapy.
Subject experienced Grade ≥ 2 neurotoxicity/immune effector cell-associated neurotoxicity syndrome (ICANS) following prior TCE or CAR T-cell therapy.
Subject has received a peripheral autologous stem cell transplant (SCT) within 12 weeks, or an allogeneic SCT within 1 year of the first dose of study drug treatment or has received an SCT and requires ongoing immunosuppressive therapy.
Subjects with human immunodeficiency virus (HIV) infection, or subjects with chronic or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Subjects with chronic HBV may be enrolled if the HBV viral load is undetectable on suppressive therapy, or if the subject has a documented cure. Subjects with HCV who have a documented cure may be enrolled.
Subject has a history of major cardiac abnormalities.
If female, subject must not be pregnant or breastfeeding.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

206

Study ID:

NCT04594642

Recruitment Status:

Recruiting

Sponsor:

AstraZeneca

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There are 27 Locations for this study

See Locations Near You

Research Site
Tampa Florida, 33612, United States
Research Site
Louisville Kentucky, 40207, United States
Research Site
New Brunswick New Jersey, 08901, United States
Research Site
Charlotte North Carolina, 28204, United States
Research Site
Columbus Ohio, 43210, United States
Research Site
Portland Oregon, 97239, United States
Research Site
Pittsburgh Pennsylvania, 15237, United States
Research Site
Austin Texas, 78704, United States
Research Site
Houston Texas, 77030, United States
Research Site
Milwaukee Wisconsin, 53226, United States
Research Site
Bedford Park , 5042, Australia
Research Site
Heidelberg , 3084, Australia
Research Site
Hobart , 7000, Australia
Research Site
Melbourne , 3004, Australia
Research Site
Chuo-ku , 104-0, Japan
Research Site
Koto-ku , 135-8, Japan
Research Site
Nagoya-shi , 460-0, Japan
Research Site
Yamagata-shi , 990-9, Japan
Research Site
Seoul , 03080, Korea, Republic of
Research Site
Seoul , 05505, Korea, Republic of
Research Site
Seoul , 06351, Korea, Republic of
Research Site
Seoul , 06591, Korea, Republic of
Research Site
Seoul , 120-7, Korea, Republic of
Research Site
Kaohsiung City , 83340, Taiwan
Research Site
Kweishan , 333, Taiwan
Research Site
Tainan , 704, Taiwan
Research Site
Taipei , 10002, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

206

Study ID:

NCT04594642

Recruitment Status:

Recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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