RightFit
RecruitingPhase 1 / Phase 2

A Study to Evaluate Safety, PK, PD and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With R/R B-Cell Malignancies.

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests AZD5492, an experimental drug that helps immune cells called T cells target cancer cells with a marker called CD20. It checks safety, side effects, and how well the drug works. It is for adults with certain B-cell cancers that came back, got worse, or did not respond after at least 2 courses of 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • A tissue test must show a mature B-cell cancer with the CD20 marker.
  • The cancer must be large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma.
  • Cancer came back, got worse, or did not respond after at least 2 prior lines of treatment.
  • Must meet limits on how much illness affects daily activity: an ECOG score of 0–2, or 0–1 in European Union countries.
  • Other study entry rules may apply.

Who can't join

  • A cancer type not listed in the entry rules.
  • Lymphoma currently affecting the brain or spinal cord.
  • A condition affecting the brain or spinal cord, including any history of seizures or epilepsy.
  • A donor stem cell transplant within 180 days, a transplant using your own stem cells within 90 days, or cell therapy within 90 days before starting study treatment.
  • A history of severe cytokine release syndrome (CRS, an immune reaction) or severe ICANS (brain or nerve problems linked to immune cell treatment), rated grade 3 or higher.
  • An active infection that is not controlled.
  • Side effects from past cancer treatment that have not gone away and are rated grade 2 or higher (moderate or worse), with some exceptions.
  • Other study exclusion rules may apply.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (10)

CA

MA

MN

NC

NJ

NY

TX

WA