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

JRCT ID: jRCT2071240051

Registered date:21/08/2024

Basic Information

• Recruitment status: Pending

Health condition(s) or Problem(s) studied

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

• Date of first enrollment: 01/10/2024
• Target sample size: 20
• Countries of recruitment: Canada,Japan,United States,Japan,Brazil,Japan,United Kingdom,Japan,Spain,Japan,France,Japan,Italy,Japan,Denmark,Japan,Germany,Japan,Australia,Japan,Sweden,Japan,South Korea,Japan,Taiwan,Japan,China,Japan,Hong Kong,Japan
• Study type: Interventional

Intervention(s)

- Module 1: AZD0486 Monotherapy in Participants with Relapsed or Refractory Follicular Lymphoma
Drug: AZD0486
Investigational Product administered via intravenous infusion.

- Module 2: AZD0486 Monotherapy in Participants with Relapsed or Refractory DLBCL
Drug: AZD0486
Investigational Product administered via intravenous infusion.

Outcome(s)

• Primary Outcome: ORR, defined as the proportion of participants achieving either a PR or CR based on Lugano 2014 Response Criteria as determined by an IRC

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include 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 or more, platelets 75,000/mm3 or more, hemoglobin 9 g/dL or more.
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 or less
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 or more

Exclude 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 or more from prior therapies; history of Grade 3 or more CRS or neurotoxicity from prior CAR-T or TCE therapy

- History of major cardiac abnormalities.

- If female, participant must not be pregnant or breastfeeding.

Related Information

• Primary Sponsor: Hibi Kazushige
• Secondary ID(s): NCT06526793