Lumi-NHL

• Research type

  Research Study

• Full title

  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)

• IRAS ID

  1012562

• Contact name

  Assim Khan

• Contact email

  UKRegulatoryAffairs@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Clinicaltrials.gov Identifier

  NCT07123454

• Research summary

  Researchers are studying a new medicine called AZD4512 for people with a type of blood cancer known as relapsed or refractory B-cell Non-Hodgkin Lymphoma (B-NHL). This means the cancer has either come back after previous treatments or hasn’t improved with standard medications. That’s why new treatments like AZD4512 are being explored. AZD4512 is an antibody-drug conjugate, which means it combines a targeted antibody with chemotherapy. AZD4512 targets B-NHL cells carrying a protein called CD22. Once attached, AZD4512 delivers chemotherapy directly into the cancer cell to destroy it. This is the first time AZD4512 is being tested in people, in a phase 1/2 ‘open label’ trial, where both participants and doctors will know what treatment is being given. The main aims are to see how safe AZD4512 is, how well it works and how the body handles the drug. About 99 people with B-NHL, whose cancer is not responding to other treatments will take part.
  The study has different parts (modules): Module 1 includes people aged 18 and older. Different doses of AZD4512 will be tried, given as an IV drip every 3 weeks, to find the safest and most effective dose. Subsequent modules may include combinations with other anti-cancer drugs. .
  Throughout the study, researchers will closely monitor for side effects and changes in health and to see how well AZD4512 is working. Participants will keep getting the medicine until their cancer worsens, the side effects become too much, or they decide to stop

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  25/LO/0608

• Date of REC Opinion

  30 Sep 2025

• REC opinion

  Further Information Favourable Opinion