Trial Title:
AZD0486 as Monotherapy in Participants With Relapsed/Refractory (R/R) B-cell NHL
NCT ID:
NCT06526793
Condition:
B-cell Non-Hodgkin Lymphoma
Follicular Lymphoma (FL)
Diffuse Large B-Cell Lymphoma (DLBCL)
Conditions: Official terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Conditions: Keywords:
AZD0486
Follicular Lymphoma (FL)
Diffuse Large B-Cell Lymphoma (DLBCL)
Non-Hodgkin lymphoma (NHL)
Relapsed/Refractory
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
The trial will assess AZD0486 monotherapy given by IV infusion. Module 1 will evaluate
the efficacy and safety of AZD0486 monotherapy at the recommended Phase 2 dose (RP2D), in
participants 18 to 80 years of age, with relapsed or refractory (R/R) follicular lymphoma
(FL) who have received ≥ 2 prior therapies. Module 2 will evaluate the efficacy and
safety of AZD0486 monotherapy at the RP2D for participants 18 to 80 years of age with
(R/R) diffuse large B-cell lymphoma (DLBCL).
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AZD0486
Description:
Investigational Product administered via intravenous infusion.
Arm group label:
Module 1: AZD0486 Monotherapy in Participants with Relapsed or Refractory Follicular Lymphoma
Arm group label:
Module 2: AZD0486 Monotherapy in Participants with Relapsed or Refractory DLBCL
Summary:
This is a Phase 2 global, multi-center, open-label study to assess the efficacy, safety
and tolerability of AZD0486 monotherapy in adult participants with relapsed/refractory
B-cell non-Hodgkin lymphoma (NHL) who have received at least two prior lines of
therapies. The study has 2 Modules: Module 1 for FL and Module 2 for DLBCL.
Detailed description:
This is a modular, Phase II, multicenter, single-arm, open-label study to evaluate the
efficacy and safety of AZD0486 monotherapy administered as an intravenous (IV) infusion
in participants with relapsed or refractory B-NHL. The purpose of this study is to
determine the efficacy and safety of AZD0486 administered at the RP2D in adults 18 to 80
years of age with relapsed or refractory B-NHL.
Criteria for eligibility:
Criteria:
1. Key Inclusion Criteria:
- Aged 18 to 80 years old
- Histologically confirmed relapsed refractory FL (Module 1) and DLBCL (Module 2)
after at least 2 prior lines of therapy
- ECOG performance status 0 to 2
- Locally confirmed CD-19 expression in lymphoma cells after progression from
last CD 19 directed therapy
- FDG-avid disease with at least one bi-dimensionally measurable nodal lesion
(defined as > 1.5 cm in its longest dimension), or extranodal lesion (defined
as > 1.0 cm in its longest dimension)
- Adequate hematological function: ANC ≥ 1000/mm3, platelets
- 75,000/mm3, hemoglobin ≥ 9 g/dL. Transfusion and/or growth factor are
allowed but counts must be stable for at least 72 hours afterwards prior
to screening
- Adequate liver function: total bilirubin <1.5x ULN, AST/ALT ≤ 3xULN Note:
Patients with documented history of Gilbert's Syndrome and in whom total
bilirubin elevations are accompanied by elevated indirect bilirubin are
eligible)
- Adequate renal function: creatinine clearance (CrCl) of ≥ 45 mL/min
The above is a summary, other inclusion criteria details may apply.
2. Key Exclusion Criteria:
- Diagnosis of CLL, Burkitt lymphoma, or Richter's transformation
- Active CNS involvement by B-NHL
- Leukemic presentation of B-NHL
- History or presence of clinically relevant CNS pathology such as epilepsy,
seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's
disease, cerebellar disease, organic brain syndrome, or psychosis
- Prior therapy with T-cell engager (TCE) within 8 weeks, CAR T- cell therapy or
autologous Hematopoietic Stem Cell Transplantation (HSCT) within 12 weeks, or
prior allogeneic HSCT within 24 weeks of first dose of AZD0486
- Requires chronic immunosuppressive therapy
- Unresolved non hematological AEs ≥ Grade 2 from prior therapies; history of ≥
Grade 3 CRS or neurotoxicity from prior CAR-T or TCE therapy
- History of major cardiac abnormalities.
- If female, participant must not be pregnant or breastfeeding.
The above is a summary, other exclusion criteria details may apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Duarte
Zip:
91010
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Tampa
Zip:
33612
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Des Moines
Zip:
50314
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Overland Park
Zip:
66204
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Rochester
Zip:
55905
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Facility:
Name:
Research Site
Address:
City:
New Brunswick
Zip:
08901
Country:
United States
Facility:
Name:
Research Site
Address:
City:
New York
Zip:
10016
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Charlotte
Zip:
28203
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Columbus
Zip:
43210
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Portland
Zip:
97239
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Pittsburgh
Zip:
15215
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Houston
Zip:
77030
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Heidelberg
Zip:
3084
Country:
Australia
Facility:
Name:
Research Site
Address:
City:
Kogarah
Zip:
NSW 2217
Country:
Australia
Facility:
Name:
Research Site
Address:
City:
Macquarie University
Zip:
2109
Country:
Australia
Facility:
Name:
Research Site
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Facility:
Name:
Research Site
Address:
City:
Sao Paulo
Zip:
01401-002
Country:
Brazil
Facility:
Name:
Research Site
Address:
City:
Sao Paulo
Zip:
05652-900
Country:
Brazil
Facility:
Name:
Research Site
Address:
City:
Barrie
Zip:
L4M 6M2
Country:
Canada
Facility:
Name:
Research Site
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Facility:
Name:
Research Site
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Facility:
Name:
Research Site
Address:
City:
Berlin
Zip:
10967
Country:
Germany
Facility:
Name:
Research Site
Address:
City:
Chemnitz
Zip:
09116
Country:
Germany
Facility:
Name:
Research Site
Address:
City:
Essen
Zip:
45122
Country:
Germany
Facility:
Name:
Research Site
Address:
City:
Wuerzburg
Zip:
97080
Country:
Germany
Facility:
Name:
Research Site
Address:
City:
Chiba-shi
Zip:
260-8717
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Kashiwa
Zip:
277-8577
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Koto-ku
Zip:
135-8550
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Kumamoto-shi
Zip:
860-0008
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Niigata-shi
Zip:
951-8520
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Okayama-shi
Zip:
700-8558
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Osaka-shi
Zip:
541-8567
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Yokohama-shi
Zip:
241-8515
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Barcelona
Zip:
8035
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Pozuelo de Alarcon
Zip:
28223
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Kaohsiung City
Zip:
833401
Country:
Taiwan
Facility:
Name:
Research Site
Address:
City:
Kaohsiung
Zip:
80756
Country:
Taiwan
Facility:
Name:
Research Site
Address:
City:
Taichung
Zip:
404
Country:
Taiwan
Facility:
Name:
Research Site
Address:
City:
Taichung
Zip:
40705
Country:
Taiwan
Facility:
Name:
Research Site
Address:
City:
Tainan City
Zip:
70403
Country:
Taiwan
Facility:
Name:
Research Site
Address:
City:
Taipei City
Zip:
106
Country:
Taiwan
Start date:
October 28, 2024
Completion date:
May 15, 2029
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06526793
