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
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 174 (estimated) |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 31 sites (La Jolla, California and 30 other locations) |
| Status | Recruiting |
| Started | September 18, 2024 |
| Main results expected | December 18, 2029 |
| Study ends | December 18, 2029 |
| Registry record updated | September 30, 2026 |
| Trial ID | NCT06542250 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
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La Jolla, California, United States Recruiting -
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Rochester, Minnesota, United States Recruiting -
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Hackensack, New Jersey, United States Recruiting -
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New York, New York, United States Recruiting -
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New York, New York, United States Recruiting -
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Charlotte, North Carolina, United States Recruiting
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Winston-Salem, North Carolina, United States Recruiting -
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Houston, Texas, United States Recruiting -
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Seattle, Washington, United States Recruiting -
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Melbourne, Australia Recruiting -
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Nedlands, Australia Recruiting -
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Calgary, Alberta, Canada Recruiting -
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Toronto, Ontario, Canada Recruiting -
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Montreal, Quebec, Canada Recruiting -
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Hangzhou, China Recruiting -
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Shanghai, China Recruiting -
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København Ø, Denmark Recruiting -
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Pessac, France Recruiting -
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Villejuif, France Recruiting -
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Göttingen, Germany Recruiting -
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München, Germany Recruiting -
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Ulm, Germany Recruiting -
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Würzburg, Germany Recruiting -
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Bologna, Italy Recruiting -
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Milan, Italy Recruiting -
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Chūōku, Japan Recruiting -
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Kashiwa, Japan Recruiting -
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Barcelona, Spain Recruiting -
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L'Hospitalet de Llobregat, Spain Recruiting -
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Madrid, Spain Recruiting -
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Boston, Massachusetts, United States Withdrawn
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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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.
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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.
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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.
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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.
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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.
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Treatment with anti-CD19-CAR-T cells for patients with relapsed B-cell tumors
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.