Abecma
idecabtagene vicleucel · BCMA CAR-T12 weeks
Kymriah: how long were the pivotal tox studies?
tisagenlecleucel · CD19 CAR-T
Longest pivotal study
31 weeks
“An in vivo study was conducted to evaluate toxicity and BD in tumor-bearing mice receiving i.v. injection of CTL019 at 1, 5, and 20x106 cells/mouse and observed up to Day 217 post-injection (p.i.) with three terminal sacrifices.”
Pivotal GLP studies
No GLP tox; non-GLP biotoxicity/BD study in B-ALL tumor-bearing immunodeficient mice, single IV, to Day 217
“The nonclinical toxicology studies were not conducted in compliance with Good Laboratory Practice (GLP), because there was no independent Quality Assurance (QA) audit of integral study parts and raw data storage was not applied in compliance with GLP regulations.”
Route in tox
Intravenous
“Route of Administration Intravenous route of administration”
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
Gintuit
allogeneic cultured keratinocytes and fibroblasts in bovine collagen · Allogeneic keratinocytes + fibroblasts52 weeks
Holoclar
autologous corneal epithelial cells containing limbal stem cells · Autologous limbal stem cells0 (no in vivo tox study)
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