CARVYKTI 3.2 × 10^6 – 1 × 10^8 cells dispersion for infusion

DRUG3 trials

Sponsors

Fundacion Pethema, Janssen Cilag International, Universitair Ziekenhuis Gent

Conditions

High-risk smoldering multiple myelomaNewly Diagnosed Multiple MyelomaPatients undergoing Fludarabine based lymphodepletion prior to CAR-T cell therapyfor hematological malignancy

Phase 2

Phase II Open-Label, Single Arm, Multicenter Study of Ciltacabtagene Autoleucel in High-Risk Smoldering Multiple Myeloma (GEM-CAR-HiRiSMM)

SuspendedCTIS2023-510560-12-00

Fundacion PethemaHigh-risk smoldering multiple myeloma

Start: 2024-10-03Target: 20Updated: 2024-08-16

A Phase 2 Multicohort Trial to Further Characterize the Efficacy and Safety of Ciltacabtagene Autoleucel

RecruitingCTIS2025-521975-30-00

Janssen Cilag InternationalNewly Diagnosed Multiple Myeloma

Start: 2025-10-03Target: 33Updated: 2025-10-29

Phase 4

Fludarabine exposure in patients undergoing Fludarabine based lymphodepletion prior to CAR-T cell therapy

Not yet recruitingCTIS2025-524278-40-00

Universitair Ziekenhuis Gentfor hematological malignancy, Patients undergoing Fludarabine based lymphodepletion prior to CAR-T cell therapy

Target: 75Updated: 2026-03-23