A Phase I/II Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Lumi-NHL
A Modular Phase I/II Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Efficacy of AZD4512 Monotherapy or in Combination With Other Anticancer Agent(s), in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (B-NHL) (Lumi-NHL)
1 other identifier
interventional
91
8 countries
21
Brief Summary
This is a Phase I/II open-label, global multicenter study to evaluate the safety and efficacy of AZD4512 monotherapy or in combination with other anticancer agent(s), in participants with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (B-NHL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2025
Typical duration for phase_1
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2025
CompletedFirst Posted
Study publicly available on registry
August 14, 2025
CompletedStudy Start
First participant enrolled
September 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
February 24, 2026
February 1, 2026
2.4 years
July 24, 2025
February 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Percentage of participants with dose-limiting toxicities (DLTs)
To identify the maximum tolerated dose (MTD) and/or doses of AZD4512 for subsequent evaluation in participants with R/R B-NHL
Up to 4 weeks
Frequency, duration, severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) and Serious Adverse Events (SAEs)
To assess the safety and tolerability of AZD4512 in participants with R/R B-NHL
From the first dose up to and including 30 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy
Frequency of SAEs/AEs leading to discontinuation of AZD4512
To assess the safety and tolerability of AZD4512 in participants with R/R B-NHL
From the first dose up to and including 30 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy
Number of participants with clinically significant alterations in vitals signs and abnormal laboratory parameters
To assess the safety and tolerability of AZD4512 in participants with R/R B-NHL
From the first dose up to and including 30 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy
Secondary Outcomes (12)
Objective response rate (ORR)
Up to 2 years
Complete response (CR) rate
Up to 2 years
Duration of response (DoR)
Up to 2 years
Progression-free survival (PFS)
Up to 2 years
Overall survival (OS)
Up to 2 years
- +7 more secondary outcomes
Study Arms (1)
Module 1: AZD4512 Monotherapy dose escalation + backfill
EXPERIMENTALIn Mod 1, the efficacy and safety of AZD4512 will be evaluated in R/R B-NHL. Module 1 will consist of both dose escalation and Pharmacodynamic/safety backfills which may be used to support MTD and/or Optimal biological dose (OBD)
Interventions
AZD4512 is an antibody-drug conjugate targeting cluster of differentiation 22 (CD22) that will be administered via IV infusion
Eligibility Criteria
You may qualify if:
- Eligible patients must be adults (≥18 years)
- Patients must have relapsed or refractory disease after at least two prior lines of therapy and lack additional standard options with survival benefit:
- A)LBCL patients must have progressed after both anti-CD20 and at least one systemic chemotherapy regimen, and have considered-or be ineligible for-CAR-T, T cell engager, and stem cell transplant modalities.
- B) Mantle cell lymphoma (MCL) patients must have had anti-CD20 and Bruton's Tyrosine Kinase (BTK) inhibitor.
- C)FL patients should have failed anti-CD20 with active disease requiring therapy.
- Additional criteria include measurable disease by Lugano 2014, Eastern Cooperative Oncology Group (ECOG) performance status ≤2, and adequate organ and bone marrow function (as specified by blood counts, cardiac ejection fraction, renal and hepatic parameters, and coagulation indices).
You may not qualify if:
- Females who are pregnant or breastfeeding are not eligible.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (21)
Research Site
Irvine, California, 92618, United States
Research Site
Jacksonville, Florida, 32224, United States
Research Site
Rochester, Minnesota, 55905, United States
Research Site
New York, New York, 10016, United States
Research Site
New York, New York, 10021, United States
Research Site
Cleveland, Ohio, 44195, United States
Research Site
Franklin, Tennessee, 37067, United States
Research Site
Melbourne, 3000, Australia
Research Site
Chengdu, 610041, China
Research Site
Guangzhou, 510060, China
Research Site
Bologna, 40138, Italy
Research Site
Milan, 20133, Italy
Research Site
Milan, 20141, Italy
Research Site
Bunkyō City, 113-8677, Japan
Research Site
Kōtoku, 135-8550, Japan
Research Site
Seoul, 03080, South Korea
Research Site
Seoul, 5505, South Korea
Research Site
Taichung, 40705, Taiwan
Research Site
Taipei, 106, Taiwan
Research Site
London, W1T 7HA, United Kingdom
Research Site
Newcastle upon Tyne, NE7 7DN, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2025
First Posted
August 14, 2025
Study Start
September 24, 2025
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2028
Last Updated
February 24, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.