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AZD4512 alone or with other medicines for relapsed or refractory B‑cell non‑Hodgkin lymphoma

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)

Phase1; Phase2 Interventional AstraZeneca · NCT07123454

This trial will try AZD4512 by itself or with other cancer drugs to see if it helps adults whose B‑cell non‑Hodgkin lymphoma has relapsed or not responded after prior treatments.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment91 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsCAR-T, Chimeric antigen receptor, chemotherapy, radiation
Locations22 sites (Irvine, California and 21 other locations)
Trial IDNCT07123454 on ClinicalTrials.gov

What this trial studies

This open‑label Phase I/II modular study tests AZD4512 as monotherapy and in combination with other anticancer agents across relapsed/refractory B‑cell non‑Hodgkin lymphoma. The trial will collect safety, pharmacokinetic, pharmacodynamic, immunogenicity, and efficacy data to define safe doses and signals of benefit. Module 1 focuses on AZD4512 monotherapy in patients who have received at least two prior lines of therapy, with additional modules for specific B‑NHL subtypes or combinations possible later. The study is being conducted at multiple centers and may expand to include other locations and combination partners over time.

Who should consider this trial

Good fit: Adults (≥18 years) with WHO‑classified B‑cell non‑Hodgkin lymphoma that is relapsed or refractory after at least two prior lines of therapy and who meet the subtype-specific eligibility criteria may qualify.

Not a fit: Patients with earlier‑line disease who still have effective standard options, those with excluded B‑NHL subtypes, or individuals with medical issues that make them ineligible for trial treatments are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, AZD4512 could provide a new treatment option for patients with relapsed or refractory B‑cell NHL who have limited standard therapies.

How similar studies have performed: Other targeted agents and combination approaches in relapsed B‑cell NHL have shown clinical activity, but AZD4512 is a novel agent and its safety and effectiveness remain unproven in humans.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Eligible patients must be adults (≥18 years)
* Documented diagnosis of B-cell non-Hodgkin lymphoma (B-NHL) as per World Health Organization (WHO) 2021 classification. In the dose escalation phase, any B-NHL subtype is allowed (excluding some subtypes), while the backfill phase restricts inclusion to defined subtypes: large B-cell lymphomas (as defined as Diffuse large B-cell lymphoma (DLBCL), Grade 3b Follicular lymphoma (FL), double/triple hit lymphomas, high-grade (B-cell lymphoma) BCL, primary mediastinal Large B-cell lymphoma (LBCL), and transformed indolent lymphoma), mantle cell lymphoma, and follicular lymphoma grades 1-3a.
* 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).

Key Exclusion criteria

* Patients are excluded if they have a diagnosis of post-transplant lymphoproliferative disease, Richter's transformation, Burkitt's lymphoma, or chronic lymphocytic leukemia (CLL)/ Small lymphocytic lymphoma (SLL), or if they have active Central nervous system (CNS) involvement from their B-NHL. Exclusion also applies to those who have received Chimeric antigen receptor-T (CAR-T) or T cell engager therapies within 90 days prior to Cycle 1 Day 1 (C1D1), any investigational drug or other systemic anticancer therapies (except low-dose corticosteroids) within 21 days or 5 half-lives, and curative radiation within 14 days (localized palliative radiotherapy is allowed).
* Other exclusions include allogeneic Hematopoietic stem cell transplantation (HSCT) within 180 days (unless stable without active (graft-versus-host disease) GVHD for ≥2 months), autologous HSCT within 90 days (unless resolved toxicities), major surgery within 28 days, use of strong CYP3A4 inhibitors or (corrected QT interval - prolonging agents at C1, or other malignancies within two years. Patients with unresolved ≥ Grade 2 AEs from prior therapy (except specified tolerable conditions), serious uncontrolled medical conditions, active infection within 14 days, or history/suspicion of significant interstitial lung disease/pneumonitis are also excluded.
* Females who are pregnant or breastfeeding are not eligible.

Where this trial is running

Irvine, California and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions B-cell Non-Hodgkin LymphomaAZD4512Non-Hodgkin LymphomaRelapsed/Refractory
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.