Recipient organisationNIHR Wellcome Trust Manchester Clinical Research Facility
NIHR supportRecorded as supported by this research centre
PeriodJan 2025 — Ongoing
In plain English
AI plain-English summary
A new antibody-based drug, JNJ-89853413, is being tested in people for the first time, aiming to force the body’s own immune T-cells to latch onto and kill cancer cells in two hard-to-treat blood cancers. This matters because patients with relapsed or refractory acute myeloid leukemia (AML) and higher-risk myelodysplastic neoplasms (MDS) have very few treatment options left. Current therapies often fail, and survival times are short. The drug works by binding two things at once: a protein called CD33 found on the surface of AML and MDS blast cells, and a specific receptor on Vγ9Vδ2 T-cells. This physical bridge is designed to make the T-cells selectively destroy the cancer cells, sparing healthy tissue. If the trial succeeds, it could establish a safe dose and show that this bispecific antibody is tolerable enough to move into larger studies. That would open a new treatment pathway for patients who currently have no effective standard of care. The research is a first-in-human dose-escalation study, so its immediate goal is safety and dosing—not efficacy—but a positive result could eventually change clinical practice for thousands of people with these aggressive blood cancers.
View original technical description
Acute leukemias are characterized by uncontrolled proliferation of immature white blood cells (WBCs) in bone marrow (soft, fatty tissue inside of bone cavities), peripheral blood and/or other sites in the body. Acute myeloid leukemia (AML) & Myelodysplastic neoplasms (MDS) are cancers in which abnormal myeloid cells, called blasts, grow uncontrollably, instead of developing into cells that fight infections & help healing.JNJ-89853413 (CD33xV?2) is a bispecific antibody* that binds CD33 protein on AML & MDS blast cells & the V?2 chain on V?9V?2 T-cells. The goal of binding these two cells together is that the T-cells will selectively kill cancer cells.*Type of protein that binds to other proteins & fights off an infection.In this study, researchers want to determine the safety & tolerability of JNJ-89853413 & to identify safe doses in participants with relapsed or refractory (R/R) AML or R/R higher-risk types of MDS.Participants aged 18 years or older or those who are at least the age of majority diagnosed with R/R AML or R/R higher-risk types of MDS.Study will be conducted in 2 parts:Part 1 (Dose Escalation): In part 1, participants will get JNJ-89853413 with increasing doses. The goal of increasing dose is to study safety of each dose & to establish a safe dose for further evaluation in part 2.Part 2 (Cohort Expansion): Participants will get treatment at the recommended dose & schedule of JNJ-89853413 established from part 1.Study will consist of a screening period followed by a treatment period. During treatment period, participants will be treated with JNJ-89853413 until worsening of AML/MDS, serious side effects, or withdrawal from study. After discontinuation of treatment, participants will be followed to monitor their health.Safety assessments include blood tests, vital sign measurements, & physical exams. Blood samples will be taken at multiple timepoints to understand how the body responds to treatment.
Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.
Is something wrong? Let us know