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 |
Only notified under the "contained use" procedure. Dossier submitted on 18/11/2021. |
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Safety and Immunogenicity of an Ad26,RSV,preF-based Vaccine in Adults Aged 18 to 59 years, Including Those at High-risk for severe RSV |
Humans |
Replication deficient Adenovirus serotype 26 containing a deoxyribonucleic acid (DNA) transgene that encodes the pre-fusion conformation-stabilized F protein (pre-F) derived from the RSV A2 strain |
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 03/05/2021. |
Administration of genetically engineered T cells (KTE-X19) in Pediatric and Adolescent Subjects with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-cell Non-Hodgkin Lymphoma |
Humans |
CD19-CAR |
B/BE/20/BVW2 |
A first-in human, Phase 1b/2, study to evaluate the safety, tolerability and immunogenicity of HPV viral vectored vaccines in women with low-grade HPV-related cervical lesions |
Humans |
The study involves two GMOs. ChAdOx1-HPV is a recombinant replication-incompetent chimpanzee-derived adenovirus (ChAdY25) viral vector. MVA-HPV is a modified vaccinia virus Ankara vector (MVA). Both vectors encode a fusion of sequences derived from HPV. |
J&JBE-018_004 |
A randomized, double-blind, placebo-controlled Phase 1/2a study to evaluate the safety, reactogenicity, and immunogenicity of Ad26COVS1 in adults aged 18 to 65 years, inclusive and adults aged 65 years and older. |
Humans |
Recombinant Adenoviral vector serotype 26 expressing the spike glycoprotein 1 from SARS-CoV2 |
Only notified under the "contained use" procedure. Dossier submitted on 18/02/2020. |
A phase III, randomized observer blinded, placebo-controlled, multi-center study, to evaluate safety and immunogenicity of the Chikungunya vaccine MV-CHIK in healthy adults |
Humans |
Recombinant measles virus vaccine strain (Schwarz strain) expressing env (E1, E2, E3), capsid C en structural protein 6K from CHIKV |
Only notified under the "contained use" procedure. Dossier submitted on 23/07/2019. |
A phase 1, randomized, placebo-controlled trial, to evaluate the optimal dose of MV-LASV, a new vaccine against LASSA virus infection, regarding safety, tolerability and immunogenicity in healthy volunteers, consisting of an unblinded dose escalation and |
Humans |
Recombinant measles virus vaccine strain (Schwarz strain) expressing the envelop glycoprotein GPC and the nucleoprotein NP with a mutated exonuclease domein (GCP-rNP) from Lassavirus |
FLU10 |
Clinical trial (phase II) to evaluate the efficacy of MVANP+M1 in a human H3N2 influenza challenge model. |
Humans |
Vaccinia virus Ankara strain expressing nucleoprotein (NP) and Matrix protein (M1) from influenza A H3N2 virus |
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 05/10/2018. |
Open-label, Single-arm Phase 1 Study to Evaluate the Shedding, Biodistribution, Safety and Immunogenicity of Ad26.RSV.preF Vaccine in Adults |
Humans |
Replication deficient Adenovirus serotype 26 containing a deoxyribonucleic acid (DNA) transgene that encodes the pre-fusion conformation-stabilized F protein (pre-F) derived from the RSV A2 strain |
Only notified under the "contained use" procedure. Dossier submitted on 25/04/2018. |
A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel versus Standard of Care Therapy in Subjects with Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7) |
Humans |
Chimeric antigen receptor against CD19 |
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/BVW2 |
Clinical trial evaluating the safety and efficacy of intracoronary administration of MYDICAR (AAV1/SERCA2a) in subjects with heart failure |
Humans |
Human SERCA2a:CA++ pump involved in the regulation of heart contraction/relaxation cycle |
Only notified under the "contained use" procedure. Dossier submitted on 02/01/1996. |
Gene therapy for the treatment of glioblastoma multiforme with in vivo tumor transduction with the herpes simplex thymidine kinase gene /ganciclovir system |
|
Thymidine Kinase (HSV-TK1), neomycin resistance (NeoR) |