Trilogy-4
Research type
Research Study
Full title
A Phase 3 Randomized Study Comparing JNJ-79635322 and an Anti-BCMAxCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti-CD38 Antibody
IRAS ID
1013495
Contact name
Elena BOLAÑOS CASCALES
Contact email
Sponsor organisation
Janssen - Cilag International NV
Eudract number
2025-522007-18
ISRCTN Number
ISRCTN80147609
Clinicaltrials.gov Identifier
Research summary
Relapsed or refractory multiple myeloma (RRMM) is a blood cancer that forms in a type of white blood cells called plasma cells. "Relapsed" means the cancer came back after treatment. "Refractory" means the cancer did not respond to treatment.
The study treatment, JNJ-79635322 bind to proteins called B-cell maturation antigen (i) and G protein-coupled receptor family C Group 5 member D (ii) found on cancer cells, and cluster of differentiation 3 found on T-cells. Upon binding, it activates T-cells and which may lead to killing of MM cells.
(i) Protein present on the surface of normal immune cells as well as myeloma cells and helps to promote normal immune activity
(ii) Protein found mainly on the surface of myeloma cells and its normal function is not known.
Participants aged 18 years or older with RRMM already treated with at least three different types of cancer therapies, including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and a drug that targets CD38.
The study will be conducted as:
1.Screening phase (up to 28 days)
2.Treatment phase: Participants will randomly (like a coin flip) divide into either of the 2 arms:
a.Arm A: Participants will receive JNJ-79635322 as an injection under the skin.
b.Arm B: Participants will receive teclistamab as an injection under the skin.
3.Follow-up phase: Participants will be monitored for their health status.
Safety assessments include physical examinations, vital signs, and laboratory tests. All side effects will be recorded till study ends. The overall duration of the study will be around 5 years.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
26/WM/0033
Date of REC Opinion
7 Apr 2026
REC opinion
Further Information Favourable Opinion