A Phase 1b Study of JNJ-80948543 in Combination with Other CD3 TCEs for R/R B-cell NHL
Research type
Research Study
Full title
A Phase 1b Study of JNJ-80948543 in Combination with Other CD3 T-cell Engagers in Participants with Relapsed/Refractory B-cell Non-Hodgkin Lymphoid Malignancies
IRAS ID
1010515
Contact name
David Wright
Contact email
Sponsor organisation
Janssen - Cilag International
ISRCTN Number
ISRCTN10023611
Research summary
Refractory or relapsed B-cell Non-Hodgkin Lymphoid (R/R B-cell NHLs) malignancies are cancers that start in white blood cells called B-lymphocytes. While curative treatments are available, the majority of patients’ cancers can come back after treatment or can be resistant to standard treatment. There is a need for continued development of effective treatments. A T-cell redirecting trispecific (CD79b x CD20 x CD3) antibody is a novel treatment for patients with B-cell malignancies developed by drug companies. Upon binding to tumor cells, T-cell redirecting antibodies* guide T-cells to the tumor, resulting in T-cell activation & tumor cell killing. In this study, researchers want to find out the RP2R & safe dose of JNJ-80948543 when used in combination with other CD3-targeting T-Cell engagers (TCEs) for treatment of R/R B-cell NHL. The investigational treatment, JNJ-80948543, is a novel T-cell redirecting trispecific antibody will be combined with JNJ-75348780, an investigational bi-specific antibody (CD22 x CD3). *Type of protein that finds & binds to other proteins and fights off an infection.
Study will consist of following:
1. Screening phase: Participants aged 18 years or older with R/R B-cell NHLs will be screened to confirm eligibility.
2. Treatment phase: Part 1 (Dose Escalation): Participants will be enrolled into different groups. The first group will receive the starting doses of JNJ-80948543 in combination with JNJ-75348780. If this dose is found to be safe, subsequent groups will receive higher doses of JNJ-80948543. This process will be repeated until serious side effects of JNJ-80948543 occur that prevent a tolerated dose.
Part 2 (Dose Expansion): Participants will receive treatment at RP2R selected in Part 1 until worsening of disease, serious side effects, or withdrawal.
1. Follow-up phase: Participants willbe followed-up to monitor their health.
Safety assessments include blood & urine tests, physical exams,vital sign,electrocardiograms.REC name
East of England - Essex Research Ethics Committee
REC reference
24/EE/0194
Date of REC Opinion
8 Oct 2024
REC opinion
Further Information Favourable Opinion