A Study to Evaluate Safety, PK, PD and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With R/R B-Cell Malignancies. (TITANium)
This is a Phase I/II study designed to evaluate if experimental T cell engaging antibody targeting CD20 AZD5492 is safe, tolerable and efficacious in participants with Relapsed or Refractory B-Cell Malignancies.
Lymphoma
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 (TITANium)
Inclusion Criteria:
- ≥18 years 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.
The above is a summary, other inclusion criteria details may apply.
Exclusion 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 CRS or Grade ≥ 3 ICANS;
- Active and uncontrolled infections;
- Unresolved AEs ≥2 Grade due to prior anticancer therapies, with some exceptions
The above is a summary, other exclusion criteria details may apply.
Linear Clinical Research, Perth, Western Australia, 6009
Contact +61 08 6382 5100
cancertrialshaem4@linear.org.au
Professor Chan Cheah
AstraZeneca
Phase 1
Phase 2
D9960C00001
NCT06542250