beta
Trial Radar AI
Clinical Trial NCT06542250 (TITANium) for B-cell Malignancies is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

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. (TITANium) Phase 1, Phase 2 174

Recruiting
Clinical Trial NCT06542250 (TITANium) is designed to study Treatment for B-cell Malignancies. It is a Phase 1 Phase 2 interventional study that is recruiting, having started on 18 September 2024, with plans to enroll 174 participants. Led by AstraZeneca, it is expected to complete by 14 February 2028. The latest data from ClinicalTrials.gov was last updated on 27 March 2026.
Brief Summary
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.
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)

Conditions
B-cell Malignancies
Other Study IDs
  • TITANium
  • D9960C00001
NCT ID Number
NCT06542250
Start Date (Actual)
2024-09-18
Last Update Posted
2026-03-27
Completion Date (Estimated)
2028-02-14
Enrollment (Estimated)
174
Study Type
Interventional
PHASE
Phase 1
Phase 2
Status
Recruiting
Keywords
CD20
CD8
T cell engager
TCR
AZD5492
Relapsed, Refractory
B-cell malignancies
CLL, Chronic lymphocytic leukemia
SLL, Small lymphocytic lymphoma
MCL, Mantle cell lymphoma
LBCL, Large B-cell lymphoma
FL, Follicular lymphoma
TITANium
TCE
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Sequential
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalModule 1: AZD5492 Monotherapy
AZD5492 monotherapy for Relapsed or Refractory B-Cell Malignancies.
AZD5492
CD8/TCR based T-cell engaging antibody targeting CD20, which is administered subcutaneously
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Frequency of dose limiting toxicities (DLTs).
DLTs are dose-limiting toxicities as defined in the study protocol.
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.
Incidence and severity of AEs, AESIs, and SAEs
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.
SAEs/AEs leading to discontinuation of AZD5492.
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.
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Overall Response Rate (ORR)
The proportion of participants with a complete response or partial response, according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL.
Module 1 - From first dose of AZD5492 up to 2 years after last dose.
Complete Response Rate (CR Rate)
The proportion of participants with a complete response (CR), according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL.
Module 1 - From first dose of AZD5492 up to 2 years after last dose.
Duration of Response (DoR)
The time from the date of first documented response until the date of documented progression (according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL) or death due to any cause.
Module 1 - From first dose of AZD5492 up to 2 years after last dose.
Progression-free Survival (PFS)
The time from the date of first dose until the date of documented disease progression (according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL) or death due to any cause.
Module 1 - From first dose of AZD5492 up to 2 years after last dose.
Overall Survival (OS)
The time from the date of first dose until date of death due to any cause.
Module 1 - From first dose of AZD5492 up to 2 years after last dose.
Pharmacokinetics of AZD5492: serum concentration of study drug
Maximum observed serum concentration of AZD5492.
Module 1 - From informed consent until 90 days after last dose of AZD5492.
Pharmacokinetics of AZD5492: Maximum plasma concentration of the study drug (Cmax).
Maximum observed plasma concentration of AZD5492.
Module 1 - From informed consent until 90 days after last dose of AZD5492.
Pharmacokinetics of AZD5492: Area under the concentration time curve (AUC).
Area under the plasma concentration-time curve.
Module 1 - From informed consent until 90 days after last dose of AZD5492.
Pharmacokinetics of AZD5492: apparent clearance
The volume of plasma from which the study drug is completely removed per unit time.
Module 1 - From informed consent until 90 days after last dose of AZD5492.
Pharmacokinetics of AZD5492: Half-life (t 1/2)
Terminal elimination half-life.
Module 1 - From informed consent until 90 days after last dose of AZD5492.
To determine the immunogenicity of AZD5492
The number of participants who develop ADAs measured in serum.
Module 1 - From informed consent until 90 days after last dose of AZD5492.
To determine the immunogenicity of AZD5492
The percentage of participants who develop ADAs measured in serum.
Module 1 - From informed consent until 90 days after last dose of AZD5492.
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  • ≥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.

  • 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.

AstraZeneca logoAstraZeneca772 active studies to explore
Study Central Contact
Contact: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
29 Study Locations in 10 Countries

California

Research Site, La Jolla, California, 92093, United States
Recruiting

Massachusetts

Research Site, Boston, Massachusetts, 02215, United States
Withdrawn

New Jersey

Research Site, Hackensack, New Jersey, 07601, United States
Recruiting

New York

Research Site, New York, New York, 10021, United States
Recruiting
Research Site, New York, New York, 10029, United States
Recruiting

North Carolina

Research Site, Charlotte, North Carolina, 28203, United States
Recruiting
Research Site, Winston-Salem, North Carolina, 27157, United States
Recruiting

Texas

Research Site, Houston, Texas, 77030, United States
Recruiting

Washington

Research Site, Seattle, Washington, 98109, United States
Recruiting
Research Site, Melbourne, 3000, Australia
Recruiting
Research Site, Nedlands, 6009, Australia
Recruiting

Alberta

Research Site, Calgary, Alberta, T2N 5G2, Canada
Recruiting

Ontario

Research Site, Toronto, Ontario, M5G 2M9, Canada
Recruiting

Quebec

Research Site, Montreal, Quebec, H3T 1R2, Canada
Recruiting
Research Site, Hangzhou, 310003, China
Recruiting
Research Site, Shanghai, 200025, China
Recruiting
Research Site, København Ø, 2100, Denmark
Recruiting
Research Site, Pessac, 33604, France
Recruiting
Research Site, Villejuif, 94805, France
Recruiting
Research Site, München, 81675, Germany
Recruiting
Research Site, Ulm, 89081, Germany
Recruiting
Research Site, Würzburg, 97080, Germany
Recruiting
Research Site, Bologna, 40138, Italy
Recruiting
Research Site, Milan, 20133, Italy
Recruiting
Research Site, Chūōku, 104-0045, Japan
Recruiting
Research Site, Kashiwa, 277-8577, Japan
Recruiting
Research Site, Barcelona, 08035, Spain
Recruiting
Research Site, L'Hospitalet de Llobregat, 08908, Spain
Recruiting
Research Site, Madrid, 28040, Spain
Recruiting