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Recruiting Phase 1/2 NCT06542250

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.

Phase 1/2 – combined early trial
Conditions: B-cell Malignancies

Sponsor: AstraZeneca

trial.available_in: БГ
Overview
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.
Who can participate
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 (\< 2 in EU countries). The above is a summary, other inclusion criteria details may apply. Exclusion Criteria: * 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.
Locations 9
Australia (1)
Research Site
Melbourne
Canada (1)
Research Site
Calgary , Alberta
China (1)
Research Site
Hangzhou
Denmark (1)
Research Site
København Ø
France (1)
Research Site
Pessac
Italy (1)
Research Site
Bologna
Japan (1)
Research Site
Chūōku
Spain (1)
Research Site
Barcelona
United States (1)
Research Site
La Jolla , California
Technical details
Status
Recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
18.09.2024
Completion date
14.02.2028
Registry ID
NCT06542250
Source
anzctr
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