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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
174
CD8/TCR based T-cell engaging antibody targeting CD20, which is administered subcutaneously
Research Site
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).
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.
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.
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.
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.
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.
AstraZeneca Clinical Study Information Center
CONTACT
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La Jolla, California, United States
Research Site
Boston, Massachusetts, United States
WITHDRAWNResearch Site
Hackensack, New Jersey, United States
RECRUITINGResearch Site
New York, New York, United States
RECRUITINGResearch Site
New York, New York, United States
RECRUITINGResearch Site
Charlotte, North Carolina, United States
RECRUITINGResearch Site
Winston-Salem, North Carolina, United States
RECRUITINGResearch Site
Houston, Texas, United States
RECRUITINGResearch Site
Seattle, Washington, United States
RECRUITINGResearch Site
Melbourne, Australia
RECRUITING...and 19 more locations
Time frame: Module 1 - From first dose of AZD5492 up to 2 years after last dose.
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.
Overall Survival (OS)
The time from the date of first dose until date of death due to any cause.
Time frame: Module 1 - From first dose of AZD5492 up to 2 years after last dose.
Pharmacokinetics of AZD5492: serum concentration of study drug
Maximum observed serum concentration of AZD5492.
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).
Maximum observed plasma concentration of AZD5492.
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).
Area under the plasma concentration-time curve.
Time frame: Module 1 - From informed consent until 90 days after last dose of AZD5492.
Pharmacokinetics of AZD5492: apparent clearance
The volume of plasma from which the study drug is completely removed per unit time.
Time frame: Module 1 - From informed consent until 90 days after last dose of AZD5492.
Pharmacokinetics of AZD5492: Half-life (t 1/2)
Terminal elimination half-life.
Time frame: Module 1 - From informed consent until 90 days after last dose of AZD5492.
To determine the immunogenicity of AZD5492
The number of participants who develop ADAs measured in serum.
Time frame: Module 1 - From informed consent until 90 days after last dose of AZD5492.
To determine the immunogenicity of AZD5492
The percentage of participants who develop ADAs measured in serum.
Time frame: Module 1 - From informed consent until 90 days after last dose of AZD5492.