A Modular Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With Relapsed or Refractory B-Cell Malignancies

JRCT ID: jRCT2031240426

Registered date:22/10/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: B-Cell Malignancies
• Date of first enrollment: 18/11/2024
• Target sample size: 12
• Countries of recruitment: Australia,Japan,Canada,Japan,China,Japan,Denmark,Japan,France,Japan,Germany,Japan,Italy,Japan,Spain,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Fixed Dosing: AZD5492 SC every 3 weeks
Step-up Dosing: AZD5492 SC on Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 1 Day 15, thereafter the drug will be administered every 3 weeks.

Outcome(s)

Primary Outcome

- Frequency of dose limiting toxicities (DLTs).

- Safety evaluation of AZD5492: Number of participants with treatment-related adverse events.

- Tolerability evaluation of AZD5492: Number of participants with treatment-related adverse events.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- 18 years or more of age;

- Histologically documented CD20+ mature B-cell neoplasm
- Large B-cell lymphoma
- Follicular lymphoma
- Mantle cell lymphoma
- Chronic lymphocytic leukemia
- Small lymphocytic lymphoma

- Relapsed, progressive and/or refractory disease following at least 2 prior lines of therapy;

- ECOG performance status of 2 or less.

The above is a summary, other inclusion criteria details may apply.

Exclude criteria

- Active CNS involvement in lymphoma or CNS pathology;

- Diagnosis of post-transplant lymphoproliferative disease, Richter's transformation, Burkitt's lymphoma, or Burkitt-like lymphoma;

- Prior allogeneic HSCT within 180 days, prior autologous HSCT within 90 days, or cell therapy within 90 days of start of therapy;

- History of Grade 3 or more CRS or Grade 3 or more ICANS;

- Active and uncontrolled infections;

- Unresolved AEs 2 or more Grade due to prior anticancer therapies, with some exceptions

The above is a summary, other exclusion criteria details may apply.

Related Information

• Primary Sponsor: Hibi Kazushige
• Secondary ID(s): NCT06542250