Recruiting 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 I / Phase II Interventional B-cell Malignancies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: AZD5492.
Who it may be relevant to: Registry conditions: B-cell Malignancies. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Canada, China, Denmark +5
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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)

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.

Interventions

Drug AZD5492
CD8/TCR based T-cell engaging antibody targeting CD20, which is administered subcutaneously

Primary outcome measures

Frequency of dose limiting toxicities (DLTs). [Time frame: Module 1 - From the first administration of AZD5492 until the end of cycle 1 (up to 5 weeks).]
Safety evaluation of AZD5492: Number of participants with treatment-related adverse events. [Time frame: Module 1 - From the first administration of AZD5492 within the duration of the treatment period, up to and including 90 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy.]
Tolerability evaluation of AZD5492: Number of participants with treatment-related adverse events. [Time frame: Module 1 - From the first administration of AZD5492 within the duration of the treatment period, up to and including 90 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy.]

Secondary outcome measures (12)

Overall Response Rate (ORR) [Time frame: Module 1 - From first dose of AZD5492 up to 2 years after last dose.]
Complete Response Rate (CR Rate) [Time frame: Module 1 - From first dose of AZD5492 up to 2 years after last dose.]
Duration of Response (DoR) [Time frame: Module 1 - From first dose of AZD5492 up to 2 years after last dose.]
Progression-free Survival (PFS) [Time frame: Module 1 - From first dose of AZD5492 up to 2 years after last dose.]
Overall Survival (OS) [Time frame: Module 1 - From first dose of AZD5492 up to 2 years after last dose.]
Pharmacokinetics of AZD5492: serum concentration of study drug [Time frame: Module 1 - From informed consent until 90 days after last dose of AZD5492.]
Pharmacokinetics of AZD5492: Maximum plasma concentration of the study drug (Cmax). [Time frame: Module 1 - From informed consent until 90 days after last dose of AZD5492.]
Pharmacokinetics of AZD5492: Area under the concentration time curve (AUC). [Time frame: Module 1 - From informed consent until 90 days after last dose of AZD5492.]
Pharmacokinetics of AZD5492: apparent clearance [Time frame: Module 1 - From informed consent until 90 days after last dose of AZD5492.]
Pharmacokinetics of AZD5492: Half-life (t 1/2) [Time frame: Module 1 - From informed consent until 90 days after last dose of AZD5492.]
To determine the immunogenicity of AZD5492 [Time frame: Module 1 - From informed consent until 90 days after last dose of AZD5492.]
To determine the immunogenicity of AZD5492 [Time frame: Module 1 - From informed consent until 90 days after last dose of AZD5492.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Sequential
Masking: Open label
Primary purpose: Treatment

Study locations

United States · 10 centers

Research Site — La Jolla
Research Site — Boston
Research Site — Rochester
Research Site — Hackensack
Research Site — New York
Research Site — New York
Research Site — Charlotte
Research Site — Winston-Salem
… and 2 more centers

Germany · 4 centers

Research Site — Göttingen
Research Site — München
Research Site — Ulm
Research Site — Würzburg

Canada · 3 centers

Research Site — Calgary
Research Site — Toronto
Research Site — Montreal

Spain · 3 centers

Research Site — Barcelona
Research Site — L'Hospitalet de Llobregat
Research Site — Madrid

Australia · 2 centers

Research Site — Melbourne
Research Site — Nedlands

China · 2 centers

Research Site — Hangzhou
Research Site — Shanghai

France · 2 centers

Research Site — Pessac
Research Site — Villejuif

Italy · 2 centers

Research Site — Bologna
Research Site — Milan

Japan · 2 centers

Research Site — Chūōku
Research Site — Kashiwa

Denmark · 1 center

Research Site — København Ø

Identifiers

NCT: NCT06542250 · D9960C00001

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗