Only notified under the "contained use" procedure. Dossier submitted on 01/03/2024. |
A Phase 1, Multicenter, Single-arm, Dose--escalation Study of CC 97540 (BMS-986353), CD19-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, Evaluating Safety and Tolerability in Participants with Relapsing Forms of Multiple Sclerosis (RMS) or Progre |
Humans |
CD19 CAR |
Only notified under the "contained use" procedure. Dossier submitted on 22/09/2023. |
A Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Idecabtagene Vicleucel (Ide-Cel) with Lenalidomide (LEN) Maintenance Versus Lenalidomide Maintenance Therapy Alone in Adult Participants with Newly Diagnosed Multiple Myeloma (N |
Humans |
BCMA CAR |
Only notified under the "contained use" procedure. Dossier submitted on 18/09/2023. |
A Phase 1, Multicenter, Open-Label Study Of CC-97540 (BMS 986353), CD19-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in Participants with Severe, Refractory Systemic Lupus Erythematosus (SLE) |
Humans |
CD19 CAR |
B/BE/21/BVW3 |
Phase I/II study to evaluate the safety and effects on Progranulin levels of PR006 in patients with Fronto-Temporal Dementia with Progranulin mutations (FTD-GRN). |
Humans |
The study involves a replication-incompetent adeno-associated virus, AAV9, lacking all AAV viral genes and encoding for the human Progranulin (GRN) gene |
Only notified under the "contained use" procedure. Dossier submitted on 28/10/2021. |
A Phase I/II, First-in-human, open-label, accelerated-titration, two-part clinical trial of TK-8001 in patients with HLA-A*02:01 genotype and advanced-stage/metastatic, MAGE-A1 + solid tumors that either have no further approved therapeutic alternative(s) |
Humans |
chimere MAGE-A1 TCRs |
Only notified under the "contained use" procedure. Dossier submitted on 02/12/2019. |
A multicentre, open-label, single ascending dose, dose-ranging, phase I/Iia study to evaluate the safety and tolerability of an autologous antigen-specific chimeric antigen receptor T regulatory cell therapy (TX200-TR101) in living donor renal transplant |
Humans |
chimeric antigen receptor specific to the donor HLA A*2 |
B/BE/18/BVW6 |
Global study of a recombinant adeno-associated virus designed to address the monogenic root cause of Spinal Muscular Atrophy |
Humans |
Recombinant adeno-associated virus serotype 9 (AAV9) containing the cDNA of the human SMN (Survival Motor Neuron) gene |
B/BE/18/BVW5 |
A Phase 1b/2a study to assess the safety and tolerability of GM Lactococcus lactis in subjects with Type 1 Diabetes Mellitus |
Humans |
Biologically contained strain of Lactococcus lactis, genetically modified to secrete human interleukin-10 and proinsulin |
bb2121-MM-001 |
A phase II, multicenter study to determine the efficacy and safety of bb2121 in subjects with relapsed and refractory multiple myeloma |
Humans |
BCMA02 (human B cell maturation antigen)-CAR |
Only notified under the "contained use" procedure. Dossier submitted on 24/04/2018. |
A phase 2, single-arm, multi-cohort, multi-center trial to determine the efficacy and safety of jcar017 in adult subjects with aggressive b-cell non-hodgkin lymphoma |
Humans |
EGFRt en chimeric antigen receptor against CD19 |
68284528MMY2001 |
A phase III, multicenter, randomized, open-label study to compare the efficacy and safety of bb2121 versus standard triplet regimens in subjects with relapsed and refractory multiple myeloma (RRMM) (KarMMa-3) |
Humans |
BCMA02 (human B cell maturation antigen) -Chimeric antigen receptor |
Only notified under the "contained use" procedure. Dossier submitted on 23/11/2016. |
A phase 2, open-label, multi-cohort, single-arm, multi-center trial to determine the safety, feasibility, and efficacy of JCAR015 in adult subjects with B-cell acute lymphoblastic leukemia |
Humans |
Chimeric antigen receptor against CD19 |
B/BE/12/BVW1 |
A multi-center, randomized, double-blind, placebo-controlled Phase I/II trial to compare the safety, tolerability and immunogenicity of the therapeutic THV01 vaccination of HIV-1 clade B infected patients under highly antiretroviral therapy |
Humans |
genes encoding the epitopes of the HIV-1 Gag, Pol and Nef proteins |
B/BE/01/V6 |
Evaluation of efficacy of Salmonella Dublin-Typhimurium vaccine, double gene deleted avirulent live culture in calves. |
calves |
genetic modification of Salmonella enterica by deletion of 2 genes (ssaC and ssaT) |
B/BE/00/V15 |
Development of a combined vaccine against equine influenza and tetanus. Experiment outside containment (clinical trial) for the study of the safety and efficacy of an intramuscular administration of recombinant canarypoxvirus expressing equine influenza v |
Horses |
haemagglutinin gene from equine influenza virus A2/Kentucky/94 or equine influenza virus A2/Newmarket/2/93 |
Only notified under the "contained use" procedure. Dossier submitted on 13/10/2000. |
A phase III open-label, comparative, multicentre trials to test the concept of durable virologic suppression in subjects with primary HIV-1 infection after intensive induction of quadruple HAART followed by double-blind randomization to HIV vaccination wi |
Humans |
vCP-1452 |
B/BE/99/VW8 |
Development of a combined live vaccine against feline leukemia. Experiment outside containment (clinical trial) for the study of the safety of a sucutaneous administration of a recombinant canarypoxvirus expressing FELV genes. |
cats |
env and gag genes of the type A virus of feline leukemia (FELV) |
Only notified under the "contained use" procedure. Dossier submitted on 26/03/1998. |
Pilot study of immunization with recombinant canarypox virus vCP1469A expressing the MAGE-1.A1 and MAGE-3.A1 cytolytic T lymphocytes epitopes in patients with malignant melanoma, non-small cell lung carcinoma, head-and-neck squamous cell carcinoma, esopha |
Humans |
HLA-A1 restricted CTL epitope of MAGE-1 and
MAGE-3 genes |
B/BE/97/VW9 |
Development of a live vaccine against feline leukemia. Experiment outside containment (clinical trial) for the study of the safety of a subcutaneous administration of a recombinant canarypoxvirus expressing FELV genes. |
cats |
env and gag genes of the type A virus of feline leukemia (FELV) |