Abecma
idecabtagene vicleucel · BCMA CAR-T12 weeks
Gintuit: how long were the pivotal tox studies?
allogeneic cultured keratinocytes and fibroblasts in bovine collagen · Allogeneic keratinocytes + fibroblasts
Longest pivotal study
52 weeks
“Grafts were harvested at 7, 14, 28, 56, 100, 180, 232, and 365 days after grafting.”
Pivotal GLP studies
No GLP repeat-dose tox; GLP ISO-10993 biocompatibility tests (systemic, subchronic subcutaneous in rabbits) and non-GLP nude mouse graft studies
“The potential toxicity of Apligraf® was evaluated via studies that reflect the initial medical device framework (i.e., biocompatibility testing in conformance to ISO-10993 standards).”
Route in tox
Topical graft (mouse); intraperitoneal, intravenous, intracutaneous, subcutaneous extracts in biocompatibility
“Sub-chronic Toxicity (Subcutaneous Injection Test – Subchronic)”
Same question, other cell therapies
Alofisel
darvadstrocel · Allogeneic adipose MSC26 weeks
Amtagvi
lifileucel · TIL therapy0 (no in vivo tox study)
Aucatzyl
obecabtagene autoleucel · CD19 CAR-T2 weeks
Breyanzi
lisocabtagene maraleucel · CD19 CAR-T14 weeks
Carvykti
ciltacabtagene autoleucel · BCMA CAR-T14 weeks
ChondroCelect
characterised viable autologous cartilage cells · Autologous chondrocytes53 weeks
Ebvallo
tabelecleucel · EBV-specific allogeneic T cells20 weeks
Encelto
revakinagene taroretcel · CNTF (encapsulated RPE cell implant)26 weeks
Holoclar
autologous corneal epithelial cells containing limbal stem cells · Autologous limbal stem cells0 (no in vivo tox study)
Kymriah
tisagenlecleucel · CD19 CAR-T31 weeks
Lantidra
donislecel · Allogeneic pancreatic islets0 (no in vivo tox study)
MACI
autologous cultured chondrocytes on porcine collagen membrane · Autologous chondrocytes53 weeks
Omisirge
omidubicel · Expanded cord blood HPC12 weeks
Provenge
sipuleucel-T · PAP-GM-CSF (autologous APC)6 weeks
Rethymic
allogeneic processed thymus tissue · Allogeneic thymus tissue39 weeks
Ryoncil
remestemcel-L · Allogeneic BM-MSC26 weeks
Spherox
spheroids of autologous matrix-associated chondrocytes · Autologous chondrocyte spheroids39 weeks
StrataGraft
allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen · Allogeneic keratinocytes + fibroblasts20 weeks
Tecartus
brexucabtagene autoleucel · CD19 CAR-T30 weeks
Tecelra
afamitresgene autoleucel · MAGE-A4 TCR-T0 (no in vivo tox study)
Yescarta
axicabtagene ciloleucel · CD19 CAR-T30 weeks
Zalmoxis
allogeneic T cells modified with HSV-TK / dLNGFR (nalotimagene carmaleucel) · HSV-TK suicide-gene T cells3 weeks
Zemcelpro
dorocubicel · UM171-expanded cord blood CD34+28 weeks
Laviv
azficel-T · Autologous fibroblastsNot stated in public reviews
Tregzi
allogeneic Treg immunotherapy with HSPC and T cells (Orca-T) · Allogeneic Treg + HSPC + TconNot stated in public reviews