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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.

ConditionB-cell Malignancies
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years of age;

Histologically documented CD20+ mature B-cell neoplasm

Large B-cell lymphoma

Follicular lymphoma

Disqualifiers

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;

Trial design

Design model

Sequential

Treatments tested in this trial

  • AZD5492

    Drug

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

Treatment groups

174 Participants
are divided into 1 treatment group
Group A: Module 1: AZD5492 MonotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Frequency of dose limiting toxicities (DLTs).

DLTs are dose-limiting toxicities as defined in the study protocol.

Time frame
Module 1 - From the first administration of AZD5492 until the end of cycle 1 (up to 5 weeks).
2

Safety evaluation of AZD5492: Number of participants with treatment-related adverse events.

Incidence and severity of AEs, AESIs, and SAEs

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.
3

Tolerability evaluation of AZD5492: Number of participants with treatment-related adverse events.

SAEs/AEs leading to discontinuation of AZD5492.

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 outcomes

1

Overall Response Rate (ORR)

The proportion of participants with a complete response or partial response, according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL.

Time frame
Module 1 - From first dose of AZD5492 up to 2 years after last dose.
2

Complete Response Rate (CR Rate)

The proportion of participants with a complete response (CR), according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL.

Time frame
Module 1 - From first dose of AZD5492 up to 2 years after last dose.
3

Duration of Response (DoR)

The time from the date of first documented response until the date of documented progression (according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL) or death due to any cause.

Time frame
Module 1 - From first dose of AZD5492 up to 2 years after last dose.
4

Progression-free Survival (PFS)

The time from the date of first dose until the date of documented disease progression (according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL) or death due to any cause.

Time frame
Module 1 - From first dose of AZD5492 up to 2 years after last dose.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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