Abecma
idecabtagene vicleucel · BCMA CAR-TNot explicitly stated; mouse MED 6.16x10^5 CAR+ cells corresponds to HED 2.05x10^8 CAR+ T cells (100 kg)
Encelto: how was the first human dose set?
revakinagene taroretcel · CNTF (encapsulated RPE cell implant)
First-in-human starting dose
Not stated in public reviews
NOAEL / key findings
No NOAEL set for device; minimal lens, vitreous and ocular inflammation; no systemic findings. rhCNTF DART NOAELs used for margins of exposure
“ITV implantation of NT-501 did not cause any effects on systemic clinical signs, gross pathology, or histopathology of non-ocular organs.”
Same question, other cell therapies
ChondroCelect
characterised viable autologous cartilage cells · Autologous chondrocytesClinical dose 0.8-1 x10^6 cells/cm2 based on animal studies, literature and ACI experience (not a formal FIH calculation)
Lantidra
donislecel · Allogeneic pancreatic isletsNo nonclinical basis; target 10,000 EIN/kg from prior Edmonton Protocol clinical experience
Ryoncil
remestemcel-L · Allogeneic BM-MSCNo formal dose-finding; 2x10^6 cells/kg clinical dose from earlier clinical/expanded access experience, not nonclinically derived
Tregzi
allogeneic Treg immunotherapy with HSPC and T cells (Orca-T) · Allogeneic Treg + HSPC + TconNo nonclinical basis; Phase 1/2 clinical safety data with a similar product supported the Phase 1b dose levels
Alofisel
darvadstrocel · Allogeneic adipose MSCNot stated in public reviews
Amtagvi
lifileucel · TIL therapyNot stated in public reviews
Aucatzyl
obecabtagene autoleucel · CD19 CAR-TNot stated in public reviews
Breyanzi
lisocabtagene maraleucel · CD19 CAR-TNot stated in public reviews
Carvykti
ciltacabtagene autoleucel · BCMA CAR-TNot stated in public reviews
Ebvallo
tabelecleucel · EBV-specific allogeneic T cellsNot stated in public reviews
Gintuit
allogeneic cultured keratinocytes and fibroblasts in bovine collagen · Allogeneic keratinocytes + fibroblastsNot stated in public reviews
Holoclar
autologous corneal epithelial cells containing limbal stem cells · Autologous limbal stem cellsNot stated in public reviews
Kymriah
tisagenlecleucel · CD19 CAR-TNot stated in public reviews
Laviv
azficel-T · Autologous fibroblastsNot stated in public reviews
MACI
autologous cultured chondrocytes on porcine collagen membrane · Autologous chondrocytesNot stated in public reviews
Omisirge
omidubicel · Expanded cord blood HPCNot stated in public reviews
Provenge
sipuleucel-T · PAP-GM-CSF (autologous APC)Not stated in public reviews
Rethymic
allogeneic processed thymus tissue · Allogeneic thymus tissueNot stated in public reviews
Spherox
spheroids of autologous matrix-associated chondrocytes · Autologous chondrocyte spheroidsNot stated in public reviews
StrataGraft
allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen · Allogeneic keratinocytes + fibroblastsNot stated in public reviews
Tecartus
brexucabtagene autoleucel · CD19 CAR-TNot stated in public reviews
Tecelra
afamitresgene autoleucel · MAGE-A4 TCR-TNot stated in public reviews
Yescarta
axicabtagene ciloleucel · CD19 CAR-TNot stated in public reviews
Zalmoxis
allogeneic T cells modified with HSV-TK / dLNGFR (nalotimagene carmaleucel) · HSV-TK suicide-gene T cellsNot stated in public reviews
Zemcelpro
dorocubicel · UM171-expanded cord blood CD34+Not stated in public reviews