Clinical trial Recruiting at 30 sites Phase1; Phase2 Interventional Ages 18 and up

Evaluating a new T cell-engaging antibody for B-cell cancers

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)

Run by AstraZeneca · NCT06542250 · Data updated 2026-11-12

This study is testing a new antibody treatment for people with tough-to-treat B-cell cancers to see if it is safe and effective after they have already tried other therapies.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment174 (estimated)
SponsorAstraZeneca
Industry-sponsored
Locations31 sites (La Jolla, California and 30 other locations)
StatusRecruiting
StartedSeptember 18, 2024
Main results expectedDecember 18, 2029
Study endsDecember 18, 2029
Registry record updatedSeptember 30, 2026
Trial IDNCT06542250 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with histologically confirmed CD20+ B-cell neoplasms who have relapsed or refractory disease after previous treatments.

Probably not a fit

Patients with neoplasms not specified in the inclusion criteria or those with active CNS involvement may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the safety, pharmacokinetics, pharmacodynamics, and efficacy of AZD5492, a T cell-engaging antibody that targets CD20, in patients with relapsed or refractory B-cell malignancies. Participants will receive the experimental treatment to determine its tolerability and effectiveness after having undergone at least two prior lines of therapy. The study will include various types of B-cell neoplasms, such as large B-cell lymphoma and chronic lymphocytic leukemia, and will monitor participants for adverse effects and treatment outcomes.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell malignancies.

How similar studies have gone: Other studies targeting CD20 with T cell-engaging therapies have shown promise, indicating potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Research Site
    La Jolla, California, United States
    Recruiting
  • Research Site
    Rochester, Minnesota, United States
    Recruiting
  • Research Site
    Hackensack, New Jersey, United States
    Recruiting
  • Research Site
    New York, New York, United States
    Recruiting
  • Research Site
    New York, New York, United States
    Recruiting
  • Research Site
    Charlotte, North Carolina, United States
    Recruiting
Show 25 more locations
  • Research Site
    Winston-Salem, North Carolina, United States
    Recruiting
  • Research Site
    Houston, Texas, United States
    Recruiting
  • Research Site
    Seattle, Washington, United States
    Recruiting
  • Research Site
    Melbourne, Australia
    Recruiting
  • Research Site
    Nedlands, Australia
    Recruiting
  • Research Site
    Calgary, Alberta, Canada
    Recruiting
  • Research Site
    Toronto, Ontario, Canada
    Recruiting
  • Research Site
    Montreal, Quebec, Canada
    Recruiting
  • Research Site
    Hangzhou, China
    Recruiting
  • Research Site
    Shanghai, China
    Recruiting
  • Research Site
    København Ø, Denmark
    Recruiting
  • Research Site
    Pessac, France
    Recruiting
  • Research Site
    Villejuif, France
    Recruiting
  • Research Site
    Göttingen, Germany
    Recruiting
  • Research Site
    München, Germany
    Recruiting
  • Research Site
    Ulm, Germany
    Recruiting
  • Research Site
    Würzburg, Germany
    Recruiting
  • Research Site
    Bologna, Italy
    Recruiting
  • Research Site
    Milan, Italy
    Recruiting
  • Research Site
    Chūōku, Japan
    Recruiting
  • Research Site
    Kashiwa, Japan
    Recruiting
  • Research Site
    Barcelona, Spain
    Recruiting
  • Research Site
    L'Hospitalet de Llobregat, Spain
    Recruiting
  • Research Site
    Madrid, Spain
    Recruiting
  • Research Site
    Boston, Massachusetts, United States
    Withdrawn

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • CD19-targeted mRNA therapy delivered by lipid nanoparticles for B-cell blood cancers

    It will try a lipid-nanoparticle mRNA therapy that generates CD19-targeted CAR-T activity inside the body for adults (18–70) with relapsed or refractory CD19-positive B-cell leukemia or lymphoma who have no standard treatment options.

    Recruiting Early Phase 1 Xinqiao Hospital of Chongqing · Chongqing, Chongqing Municipality · NCT07349849

  • Emavusertib plus zanubrutinib for CLL and other B‑cell cancers

    This test will see if adding emavusertib to the BTK inhibitor zanubrutinib can reduce measurable residual disease in adults with chronic lymphocytic leukemia or other B‑cell malignancies.

    Recruiting at 11 sites Phase 2 Curis, Inc. · Miami Beach, Florida and 10 other locations · NCT07271667

  • Anti-CD22 CAR‑T cell therapy for CD22‑positive B‑cell cancers

    This trial will try a one-time CAR‑T cell therapy that targets CD22 in children and adults whose relapsed or refractory B‑cell cancers still express CD22 after prior treatments, including CD19‑directed therapy.

    Recruiting Phase 1/2 Sheba Medical Center · Ramat Gan, G · NCT07135466

  • JY231 injection for relapsed or refractory CD19-positive B-cell malignancies

    This trial will test whether a single intravenous injection of JY231, an in vivo CAR-T therapy, can help adults with relapsed or refractory CD19-positive B-cell malignancies.

    Recruiting 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China · Kunming, Yunnan · NCT07065279

  • Evaluating SYS6005 for advanced malignant tumors

    This study is testing a new treatment called SYS6005 to see if it is safe and effective for people with advanced malignant tumors.

    Recruiting Phase 1 CSPC Megalith Biopharmaceutical Co.,Ltd. · Tianjin · NCT06958679

  • Treatment with anti-CD19-CAR-T cells for patients with relapsed B-cell tumors

    This study is testing a new treatment using anti-CD19-CAR-T cells to see if it can help patients with relapsed B-cell tumors feel better.

    Recruiting Early Phase 1 Shanghai Tongji Hospital, Tongji University School of Medicine · Shanghai, Shanghai Municipality · NCT06375161

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.