AZD0486 as Monotherapy in Participants with Relapsed/Refractory (R/R) B-cell NHL

Study identifier:D7404C00001

ClinicalTrials.gov identifier:NCT06526793

EudraCT identifier:N/A

CTIS identifier:2023-505789-27-00

Will Be Recruiting

Official Title

A Modular Phase 2, Single-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of AZD0486 in Participants with Relapsed or Refractory (R/R) B-cell Non-Hodgkin Lymphoma

Medical condition

B-cell Non-Hodgkin Lymphoma, Diffuse Large B-Cell Lymphoma (DLBCL)

Phase

Phase 2

Healthy volunteers

Study drug

AZD0486

Sex

All

Estimated Enrollment

240

Study type

Interventional

Age

18 Years - 80 Years

Date

Study Start Date: 28 Oct 2024

Estimated Primary Completion Date: 08 Feb 2027

Estimated Study Completion Date: 15 May 2029

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

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.

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.

No locations available

Arms	Assigned Interventions
Experimental: Module 1: AZD0486 Monotherapy in Participants with Relapsed or Refractory Follicular Lymphoma In Module 1, the efficacy and safety of AZD0486 at the RP2D will be evaluated in R/R FL. AZD0486 will be administered as intravenous infusion.	Drug: AZD0486 Investigational Product administered via intravenous infusion. Other Name: N/A
Experimental: Module 2: AZD0486 Monotherapy in Participants with Relapsed or Refractory DLBCL In Module 2, the efficacy and safety of AZD0486 at the RP2D will be evaluated in R/R DLBCL. AZD0486 will be administered as intravenous infusion.	Drug: AZD0486 Investigational Product administered via intravenous infusion. Other Name: N/A

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]