Recruiting PHASE1, PHASE2 B-cell Malignancies

Tests treatment safety and results for B-cell Malignancies

Official title 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.

ClinicalTrials.gov ID: NCT06542250

What this study is testing

What is AZD5492?

AZD5492 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for b-cell malignancies.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • ≥18 years of age;
  • Histologically documented CD20+ mature B-cell neoplasm
  • Large B-cell lymphoma
  • Follicular lymphoma
  • Mantle cell lymphoma

You likely can't join if

  • 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;
See the full eligibility criteria
Who can join
  • ≥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 details may apply.
What rules you out
  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • La Jolla, California, United States
  • Boston, Massachusetts, United States
  • Rochester, Minnesota, United States
  • Hackensack, New Jersey, United States
  • New York, New York, United States
  • Charlotte, North Carolina, United States
  • Winston-Salem, North Carolina, United States
  • Houston, Texas, United States
  • Seattle, Washington, United States
  • Melbourne, Australia
  • Nedlands, Australia
  • Calgary, Alberta, Canada
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Hangzhou, China
  • Shanghai, China
  • København Ø, Denmark
  • Pessac, France
  • Villejuif, France
  • Göttingen, Germany

+ 10 more site(s).

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include La Jolla, California, United States; Boston, Massachusetts, United States; Rochester, Minnesota, United States; Hackensack, New Jersey, United States; New York, New York, United States; Charlotte, North Carolina, United States and 24 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.