Search the database for deliberate release of GM medicinal products
EU record number
Title
Company / Sponsor
Treated organism
Genetic modification
Only notified under the "contained use" procedure. Dossier submitted on 23 October, 2024
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A Phase 2, randomized, open-label, controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe refractory idiopathic inflammatory myopathies. Novartis Pharma Services AG
Humans
CD19 CAR
Only notified under the "contained use" procedure. Dossier submitted on 23 October, 2024
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Phase II study evaluating rapcabtagene autoleucel in participants with diffuse cutaneous systemic sclerosis (dcSSc) Novartis Pharma Services AG
Humans
CD19 CAR
CYAD-211-001
An open-label phase I, multi-center study to determine the recommended dose of the chimeric antigen receptor T-cell treatment CYAD-211 after a non-myeloablative preconditioning chemotherapy in multiple myeloma patients with relapsed or refractory disease. Celyad
Humans
BCMA-CAR and ShRNA CD3ζ
CYAD-N2T-005
An open-label, Phase I/II study to assess the safety and clinical activity of NKR-2 treatment administration after non-myeloablative preconditioning chemotherapy in relapse/refractory acute myeloid leukemia or myelodysplasic syndrome patient (DEPLETHINK - Celyad
Humans
NKG2D-chimeric antigen receptor
CYAD-02-001
An open-label, phase I, multi-center study to determine in relapsed/refractory acute myeloid leukemia or myelodysplasic syndrome patients the recommended dose of CYAD-02 after a non-myeloablative preconditioning chemotherapy followed by a potential CYAD-0 Celyad
Humans
NKG2D-chimeric antigen receptor, ShRNA targeting the endogenous RNA of NKG2D ligands MICA and MICB and truncated CD19 reporter protein
CYAD-N2L-101
An open-label, Phase I study to assess the safety of multiple doses of CYAD-101, administered after standard FOLFOX chemotherapy in patients with unresectable metastatic colorectal cancer (alloSHRINK-study-Standard cHemotherapy Regimen and Immunotherapy w Celyad
Humans
NKG2D-chimeric antigen receptor, the truncated CD19 tag and the TIM8 molecule which interferes with the interaction between the natural TCR and endogenous CD3ζ
CYAD-N2T-006
An open-label, phase I study to assess the safety of NKR-2 treatment administrated concurrently with 5-azacytidine in tretment-naïve acute myeloid leukemia or myelodysplastic syndrome patients not candidates for intensive therapy (EPITHINK - EPIgenetic dr Celyad
Humans
NKG2D-chimeric antigen receptor
Only notified under the "contained use" procedure. Dossier submitted on 25 October, 2016
.
A multinational, open-label, dose escalation Phase I/II study to assess the safety and clinical activity of multiple administrations of NKR-2 in patients with different metastatic tumor types Celyad
Humans
NKG2D-chimeric antigen receptor
Only notified under the "contained use" procedure. Dossier submitted on 14 October, 2015
.
A phase II, single-arm, multi-center trial to determine the efficacy and safety of CTL019 in pediatric patients with relapsed and refractory B-cell acute lymphoblastic leukemia Novartis Pharma Services AG
Humans
Chimeric antigen receptor against CD19
Only notified under the "contained use" procedure. Dossier submitted on 9 November, 2001
.
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
