RecruitingPhase 1Phase 2NCT06542250
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.
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)
Sponsor
AstraZeneca
Enrollment
174 participants
Start Date
Sep 18, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria9
- ≥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 (\< 2 in EU countries).
Exclusion Criteria7
- Any neoplasm histology not specified in the IC section;
- Active CNS involvement in lymphoma;
- CNS pathology including but not limited to any history of seizure disorder/epilepsy;
- 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
Interventions
DRUGAZD5492
CD8/TCR based T-cell engaging antibody targeting CD20, which is administered subcutaneously
Locations(29)
View Full Details on ClinicalTrials.gov
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NCT06542250
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