Status:
RECRUITING
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.
Lead Sponsor:
AstraZeneca
Conditions:
B-cell Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 Ma...
Eligibility Criteria
Inclusion
- ≥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).
- The above is a summary, other inclusion criteria details may apply.
Exclusion
- 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
- The above is a summary, other exclusion criteria details may apply.
Key Trial Info
Start Date :
September 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 14 2028
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT06542250
Start Date
September 18 2024
End Date
February 14 2028
Last Update
December 15 2025
Active Locations (29)
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1
Research Site
La Jolla, California, United States, 92093
2
Research Site
Boston, Massachusetts, United States, 02215
3
Research Site
Hackensack, New Jersey, United States, 07601
4
Research Site
New York, New York, United States, 10021