LLPC Associated studies

KT-US-484-0136: An Adaptive Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Axicabtagene Ciloleucel versus Standard of Care Therapy as First-Line Therapy in Subjects with High-Risk Large B-Cell Lymphoma.

DLBCL, not otherwise specified (de novo or transformed indolent NHL), high-grade B-cell lymphoma with MYC and BCL2 ± BCL6 rearrangements with diffuse LBCL histology (DHL/THL), PMBCL, T/HRBCL, or FL3b.
Primary refractory or relapse ≤ 12 months from initiation of frontline therapy. Transplant eligible.

2 cohorts:
Cohort 1: R/R DLBCL of Folliculair lymfoom gr 3b after 2 lines systemic therapy or after 1 line systemic therapy in transplant-ineligible patients. Cohort for CART-exposed patients is temporary closed
Cohort 2: Folliculair lymfoom gr 1-3a and marginale zone lymfoom after 2 of more lines systemic therapy (including an anti CD20 antibody)  - open 

Part 1 (dose escalation): To evaluate the safety of BYON4228 alone and in combination with rituximab to determine the maximum tolerated dose (MTD), or optimal biological dose (OBD) if the MTD is not reached, and recommended combination dose regimen for expansion (RDE);
Part 2 (expansion): To evaluate the objective tumor response rate (ORR).

In- and exclusion criteria

A Phase 1, Dose Escalation, and Cohort Expansion Study Evaluating NX-5948, a Bruton’s Tyrosine Kinase (BTK) Degrader, in Adults with Relapsed/Refractory B-cell Malignancies

R/R CLL/SLL; DLBCL; tFL; Richter; high-grade B-cell lymphoma; FL; MCL; MZL; MW; PCNSL
For all indications at least 2 prior therapies. Exception: PCNSL can be included after 1 previous therapy. 

In- en exclusiecriteria
Advertentie text (approved by EC)