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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)


Description

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.

Trial Eligibility

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.

Study Info

Organization

AstraZeneca


Primary Outcome

Frequency of dose limiting toxicities (DLTs).


Outcome Timeframe Module 1 - From the first administration of AZD5492 until the end of cycle 1 (up to 5 weeks).

NCTID NCT06542250

Phases PHASE1,PHASE2

Primary Purpose TREATMENT

Start Date 2024-09-18

Completion Date 2028-02-16

Enrollment Target 174

Interventions

DRUG AZD5492

Locations Recruiting

Research Site

United States, California, La Jolla


Research Site

United States, Massachusetts, Boston


Research Site

United States, New Jersey, Hackensack


Research Site

United States, New York, New York


Research Site

United States, North Carolina, Charlotte


Interested in joining this trial?

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