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)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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≥18 years of age;
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Histologically documented CD20+ mature B-cell neoplasm
- Large B-cell lymphoma
- Follicular lymphoma
- Mantle cell lymphoma
- Chronic lymphocytic leukemia
- Small lymphocytic lymphoma
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Relapsed, progressive and/or refractory disease following at least 2 prior lines of therapy;
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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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
174 participants in 1 patient group
Trial contacts and locations
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Central trial contact
AstraZeneca Clinical Study Information Center
Data sourced from clinicaltrials.gov
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