B/BE/22/BVW6
A phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled Systemic Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of SRP-9001 in Non-Ambulatory and Ambulatory Subjects With Duchenne Muscular Dystrophy (ENVISION) Sarepta Therapeutics
Humans
Non-replicating recombinant vector derived from adeno-associated virus AAV, serotype rh74, lacking all AAV viral genes and carrying the human micro-dystrophin (hMicro-Dys) gene
B/BE/22/BVW5
A two-part, open-label systemic gene delivery study to evaluate the safety and expression of RO7494222 (SRP-9001) in subjects under the age of four with Duchennne Muscular Dystrophy (ENVOL) F. Hoffmann-La Roche
Humans
Non-replicating recombinant vector derived from adeno-associated virus AAV, serotype rh74, lacking all AAV viral genes and carrying the human micro-dystrophin (hMicro-Dys) gene
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 Nouscom Srl
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 2 September, 2022
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A single-arm, open-label, multi-centre, phase I/II study evaluating the safety and clinical activity of QEL-001, an autologous CAR T regulatory cell treatment targeting HLA-A2, in HLA-A2/ A28neg patients that have received an HLA-A2pos liver transplant Quell Therapeutics Limited
Humans
BCMA CAR; shRNA CD3ζ; tCD34
Only notified under the "contained use" procedure. Dossier submitted on 25 July, 2022
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A Phase I/II study to evaluate the feasibility, safety and preliminary efficacy of point-of-care manufactured anti-CD19 CAR T in subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) (CP0101-CLL) – Eup CellPoint B.V. (a Galapagos company)
Humans
CD19 CAR
Only notified under the "contained use" procedure. Dossier submitted on 7 June, 2022
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A phase I/II open label, multicenter study evaluating the feasibility, safety and efficacy of point-of-care manufactured anti-BCMA CAR T cells (BCMACP03) in subjects with relapsed/refractory Multiple Myeloma (r/r MM) (Papilio-1) CellPoint B.V. (a Galapagos company)
Humans
BCMA CAR
B/BE/01/B7
Specific immunotherapy against MUC-1 antigen - Study TG4010.04 : "Phase II study with TG4010(MVA-MUC-1-IL-2) in patients with metastatic breast cancer", Study TG4010.05 : "Phase II study with TG 4010 in patients with non small cell lung cancer" Transgene S.A.
Humans
sequences coding for the human MUC-1 antigen and IL-2
B/BE/01/V6
Evaluation of efficacy of Salmonella Dublin-Typhimurium vaccine, double gene deleted avirulent live culture in calves. Pharmacia Animal health
calves
genetic modification of Salmonella enterica by deletion of 2 genes (ssaC and ssaT)
Only notified under the "contained use" procedure. Dossier submitted on 9 November, 2001
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A phase III, multi-center, open-label, randomized study to compare the effectiveness and safety of intratumoral administration of INGN 201 in combination with chemotherapy versus chemotherapy alone in 288 patients with recurrent squamous cell carcinoma of Introgen Therapeutics, Inc.
Humans
Wild-type p53
Only notified under the "contained use" procedure. Dossier submitted on 9 November, 2001
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A phase III, multi-center, open-label, randomized study to compare the overall survival and safety of bi-weekly intratumoral administration of INGN 201 versus weekly methotrewate in 240 patients with refractory squamous cell carcinoma of the head and neck Introgen Therapeutics, Inc.
Humans
Wild-type p53
B/BE/98/B6
Clinical research program : Gene-therapy by the Use of a Recombinant Adenovirus in the Treatment of p53 Deficient Cancers Schering Plough NV/SA
Humans
wild-type p53 tumor suppressor gene
Only notified under the "contained use" procedure. Dossier submitted on 9 June, 1998
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A phase II, multi-center, open label, randomized study to evaluate biodistribution and transmission, effectiveness and safety of two treatment regimens of Ad5CMV-p53 administered by intra-tumoral injections in 40 evaluable patients with advanced squamous Rhone-Poulenc Rorer
Humans
Wild-type p53
Only notified under the "contained use" procedure. Dossier submitted on 4 June, 1998
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Phase II randomized study of immunotherapy of advanced breast cancer by repeated intramuscular injection of a recombinant vaccinia virus containing sequences coding for human MUC-1 and interleukin-2 (TG1031) comparing two doses levels Transgene
Humans
Muc-1 and Interleukine 2 (IL-2)
Only notified under the "contained use" procedure. Dossier submitted on 26 March, 1998
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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 Pasteur Mérieux Connaught
Humans
HLA-A1 restricted CTL epitope of MAGE-1 and
MAGE-3 genes
