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B/BE/23/BVW2 |
A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887(AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular De |
Humans |
Non-replicating recombinant vector derived from adeno-associated virus AAV2 carrying the soluble human CD59 gene |
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B/BE/22/BVW4 |
A Phase I/II, Multicenter, Open-Label Study of Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors |
Humans |
The study involves two GMOs: (i) A replication-incompetent adenovirus (GAd20 with deletions of the viral E1, E3 and E4 coding regions) isolated from a gorilla and encoding the FSP neoantigens; (ii) an attenuated, replication-defective orthopoxvirus (Modified Vaccinia virus Ankara), encoding for the same neoantigens. |
|
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 |
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B/BE/20/BVW5 |
Phase 1b Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of Nous-PEV, with pembrolizumab, in Patients with Unresectable Stage III / IV Cutaneous Melanoma and with Stage IV NSCLC |
Humans |
The study involves two GMOs: (i) A replication-incompetent adenovirus (GAd20 with deletions of the viral E1, E3 and E4 coding regions) isolated from a gorilla and encoding the PEV neoantigens gene; (ii) an attenuated, replication-defective orthopoxvirus (Modified Vaccinia virus Ankara), encoding for the neoantigens gene. |
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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. |
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Only notified under the "contained use" procedure. Dossier submitted on 02/12/2019. |
A randomized Double-blind, Placebo-controlled First-in-Human, Phase 1/2a Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Monovalent HPV16 and HPV18 Ad26-vectored Vaccine Components and an MVA-vectored HPV16/18 Vaccine Component in Oth |
Humans |
Recombinant Adenovirus serotype 26 and MVA Bavarian Nordic strain |
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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 |
|
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 |
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68284528MMY2003 |
A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA, versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects with R |
Humans |
Autologous T cells expressing BCMA (B-cell maturation antigen)-CAR |
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68284528MMY2001 |
A Phase 1b-2, open-label study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) therapy directed against BCMA in subjets with relapsed or refractory multiple myeloma. Protocol 68284528MMY2001 |
Humans |
B-cell maturation antigen (BCMA)-chimeric antigen receptor |
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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 |
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Only notified under the "contained use" procedure. Dossier submitted on 29/03/2018. |
An Open-label Randomized Phase 1b/2 Study of the Efficacy and Safety of JNJ-64041757, a Live Attenuated Listeria monocytogenes Immunotherapy, in Combination with Nivolumab Versus Nivolumab Monotherapy in Subjects With Advanced Adenocarcinoma of the Lung |
Humans |
Genetically modified, live attenuated Listeria monocytogenes (Lm ΔactA/ΔinlB) |
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Only notified under the "contained use" procedure. Dossier submitted on 22/03/2016. |
Phase I study to evaluate the safety and immunogenicity of a bivalent recombinant vaccine against human cytomegalovirus (HCMV). |
Humans |
Two replication-deficient lymphocytic choriomeningitidis virus (rLCMV) vectors, one expressing a truncated gBprotein of HCMV and one expressing the pp65 protein of the human CMV |
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B/BE/11/BVW2 |
Clinical Study BNIT-PRV-301 - A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer |
Humans |
Human gene coding for the prostate-specific antigen (PSA) and genes encoding 3 human immunological costimulatory molecules |
|
B/BE/07/BVW3 |
A multi-centre phase I study to evaluate the safety and tolerability of a heterologous prime-boost vaccination with INX102-3697 HBV pDNA/INX102-0557 HBV MVA in healthy volunteers and HBeAg+ chronic hepatitis patients |
Humans |
Hepatitis B virus polyepitope gene |
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Only notified under the "contained use" procedure. Dossier submitted on 01/02/2005. |
A Controlled, Randomised, Parallel Group, Multicentre Study of the Efficacy and Safety of Herpes Simplex Virus-Thymidine Kinase Gene Therapy (CereproTM), with Subsequent Ganciclovir, for the Treatment of Patients with Operable High-Grade Glioma |
Humans |
Thymidine Kinase (HSV-TK1) |
