A Phase 1/2 interventional study of AZD5492 in B-cell Malignancies, sponsored by AstraZeneca. Recruiting at 31 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by AstraZeneca · Phase 1/2, Interventional, and Treatment
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.
AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
documented CD20+ mature B-cell neoplasm
The above is a summary, other inclusion criteria details may apply.
Exclusion Criteria:
The above is a summary, other exclusion criteria details may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
AZD5492 monotherapy for Relapsed or Refractory B-Cell Malignancies.
Drug: AZD5492
CD8/TCR based T-cell engaging antibody targeting CD20, which is administered subcutaneously
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.
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.
Not enrolling at this site — choose another above.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://www.astrazenecaclinicaltrials.com/our-transparency-commitments/. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Supporting information: Study protocol
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://www.astrazenecaclinicaltrials.com/our-transparency-commitments/.
Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · www.vivli.org
Started Sep 2024 (actual). Primary completion is estimated for Dec 2029, 63 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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