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Tecelra: how long were the pivotal tox studies?

afamitresgene autoleucel · MAGE-A4 TCR-T
Longest pivotal study
0 (no in vivo tox study)
“Standard in vivo single-dose or repeat-dose toxicity studies were not conducted with afamitresgene autoleucel due to the lack of appropriate animal models for testing of human TCR engineered T-cells.”
✓ VerifiedFDA multi-discipline review, p. 39Source ↗
Pivotal GLP studies
No in vivo tox; in vitro X-scan/MAGE-family peptide cross-reactivity, alloreactivity, normal/iPSC cell co-culture; murine xenograft efficacy
“A comprehensive analysis of cross-reactivity was performed using a peptide library screen with single amino-acid substitutions at each position of the antigenic peptide sequence (X-scan) and peptides from MAGE family member proteins.”
✓ VerifiedFDA summary basis for approval, p. 13Source ↗
Route in tox
Not stated in public reviews
Not reported in the public reviews. Reviewers summarise selectively, so this usually means it wasn't discussed publicly, not that it wasn't studied.

Same question, other cell therapies

Abecma

idecabtagene vicleucel · BCMA CAR-T
12 weeks

Alofisel

darvadstrocel · Allogeneic adipose MSC
26 weeks

Amtagvi

lifileucel · TIL therapy
0 (no in vivo tox study)

Aucatzyl

obecabtagene autoleucel · CD19 CAR-T
2 weeks

Breyanzi

lisocabtagene maraleucel · CD19 CAR-T
14 weeks

Carvykti

ciltacabtagene autoleucel · BCMA CAR-T
14 weeks

ChondroCelect

characterised viable autologous cartilage cells · Autologous chondrocytes
53 weeks

Ebvallo

tabelecleucel · EBV-specific allogeneic T cells
20 weeks

Encelto

revakinagene taroretcel · CNTF (encapsulated RPE cell implant)
26 weeks

Gintuit

allogeneic cultured keratinocytes and fibroblasts in bovine collagen · Allogeneic keratinocytes + fibroblasts
52 weeks

Holoclar

autologous corneal epithelial cells containing limbal stem cells · Autologous limbal stem cells
0 (no in vivo tox study)

Kymriah

tisagenlecleucel · CD19 CAR-T
31 weeks

Lantidra

donislecel · Allogeneic pancreatic islets
0 (no in vivo tox study)

MACI

autologous cultured chondrocytes on porcine collagen membrane · Autologous chondrocytes
53 weeks

Omisirge

omidubicel · Expanded cord blood HPC
12 weeks

Provenge

sipuleucel-T · PAP-GM-CSF (autologous APC)
6 weeks

Rethymic

allogeneic processed thymus tissue · Allogeneic thymus tissue
39 weeks

Ryoncil

remestemcel-L · Allogeneic BM-MSC
26 weeks

Spherox

spheroids of autologous matrix-associated chondrocytes · Autologous chondrocyte spheroids
39 weeks

StrataGraft

allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen · Allogeneic keratinocytes + fibroblasts
20 weeks

Tecartus

brexucabtagene autoleucel · CD19 CAR-T
30 weeks

Yescarta

axicabtagene ciloleucel · CD19 CAR-T
30 weeks

Zalmoxis

allogeneic T cells modified with HSV-TK / dLNGFR (nalotimagene carmaleucel) · HSV-TK suicide-gene T cells
3 weeks

Zemcelpro

dorocubicel · UM171-expanded cord blood CD34+
28 weeks

Laviv

azficel-T · Autologous fibroblasts
Not stated in public reviews

Tregzi

allogeneic Treg immunotherapy with HSPC and T cells (Orca-T) · Allogeneic Treg + HSPC + Tcon
Not stated in public reviews

Summary across all 27 cell therapies →