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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.
NCT06542250 · AstraZeneca
In plain English
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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)
About this study
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.
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 design
Enrollment target: 174 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-09-18
Estimated completion: 2029-12-18
Last updated: 2026-08-07
Interventions
Drug: AZD5492
Primary outcomes
- • Frequency of dose limiting toxicities (DLTs). (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. (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. (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.)
Sponsor
AstraZeneca · industry
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
All locations (31)
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La Jolla, California, United States
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Boston, Massachusetts, United States
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Rochester, Minnesota, United States
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Hackensack, New Jersey, United States
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New York, New York, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Houston, Texas, United States
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Seattle, Washington, United States
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Melbourne, Australia
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Nedlands, Australia
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Calgary, Alberta, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Hangzhou, China
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Shanghai, China
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København Ø, Denmark
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Pessac, France
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Villejuif, France
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Göttingen, Germany
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München, Germany
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Ulm, Germany
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Würzburg, Germany
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Bologna, Italy
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Milan, Italy
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Chūōku, Japan
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Kashiwa, Japan
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Barcelona, Spain
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L'Hospitalet de Llobregat, Spain
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Madrid, Spain