A Phase 1 Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or MDS
Research type
Research Study
Full title
A Phase 1, First-in-Human, Dose Escalation Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
IRAS ID
1010815
Contact name
David Wright
Contact email
Sponsor organisation
Janssen - Cilag International
Eudract number
2024-513199-16
ISRCTN Number
ISRCTN16221474
Research summary
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 (CD33xVδ2) is a bispecific antibody* that binds CD33 protein on AML & MDS blast cells & the Vδ2 chain on Vγ9Vδ2 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.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
24/SC/0351
Date of REC Opinion
21 Nov 2024
REC opinion
Further Information Favourable Opinion