Recruiting
Phase 1
Phase 2

AZD5492

Sponsor:

AstraZeneca

Code:

NCT06542250

Conditions

B-cell Malignancies

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AZD5492

Study Details

Brief summary:

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.

Conditions

B-cell Malignancies

Study ID

NCT06542250

Start date

Sep 18, 2024

Status verified date

Aug, 2026

Completion date

Dec 18, 2029

Anticipated

Primary completion date

Dec 18, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

174 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Module 1: AZD5492 Monotherapy

AZD5492 monotherapy for Relapsed or Refractory B-Cell Malignancies.

Interventions

AZD5492

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

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

La Jolla, California, United States, 92093

Research Site

Recruiting

Rochester, Minnesota, United States, 55905

Research Site

Recruiting

Hackensack, New Jersey, United States, 07601

Research Site

Recruiting

New York, New York, United States, 10021

Research Site

Recruiting

New York, New York, United States, 10029

Research Site

Recruiting

Charlotte, North Carolina, United States, 28203

Research Site

Recruiting

Winston-Salem, North Carolina, United States, 27157

Research Site

Recruiting

Houston, Texas, United States, 77030

Research Site

Recruiting

Seattle, Washington, United States, 98109

Research Site

Recruiting

Calgary, Alberta, Canada, T2N 5G2

Research Site

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Research Site

Recruiting

Montreal, Quebec, Canada, H3T 1R2

More Information

Sponsor

AstraZeneca

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Keywords

  • CD20
  • CD8
  • T cell engager
  • TCR
  • AZD5492
  • Relapsed, Refractory
  • B-cell malignancies
  • CLL, Chronic lymphocytic leukemia
  • SLL, Small lymphocytic lymphoma
  • MCL, Mantle cell lymphoma
  • LBCL, Large B-cell lymphoma
  • FL, Follicular lymphoma
  • TITANium
  • TCE

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-07.