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Atlas/Cell therapy/Tecartus/Skipped studies

Tecartus: genotox, carcinogenicity and repro: done or skipped?

brexucabtagene autoleucel · CD19 CAR-T
Check my plan vs. these
Genotoxicity
Not conducted (traditional); vector integration site analysis performed instead
“Traditional genotoxicity studies were not conducted using KTE-X19, however, given the use of a murine γ-retroviral vector to stably integrate the anti-CD19 CAR into the T cell genome, a risk associated with insertional mutagenesis exists.”
✓ VerifiedFDA pharmacology/toxicology review, p. 5Source ↗
Carcinogenicity
Not conducted
“No carcinogencity/tumorigenicity studies were conducted.”
✓ VerifiedFDA pharmacology/toxicology review, p. 6Source ↗
Reproductive & developmental
Not conducted (product characteristics, safety profile)
“No animal reproductive and developmental toxicity studies were conducted with KTE-X19, which is acceptable based on the product characteristics and safety profile.”
✓ VerifiedFDA summary basis for approval, p. 12Source ↗
Safety pharmacology
Not conducted
“No secondary pharmacodynamics studies, safety pharmacology studies and pharmacodynamic drug interaction studies were conducted.”
✓ VerifiedEMA assessment report, p. 32Source ↗

Same question, other cell therapies

Abecma

idecabtagene vicleucel · BCMA CAR-T
Not conducted (traditional); insertion site analysis of 20 clinical lots

Alofisel

darvadstrocel · Allogeneic adipose MSC
Not conducted; cell-based product does not interact with DNA

Amtagvi

lifileucel · TIL therapy
Not conducted (not warranted given product characteristics and biological activity)

Aucatzyl

obecabtagene autoleucel · CD19 CAR-T
Not conducted (third-generation SIN lentiviral vector, release criterion, long-term clinical monitoring for insertional mutagenesis)

Breyanzi

lisocabtagene maraleucel · CD19 CAR-T
Not conducted (traditional); lentiviral integration site mapping instead

Carvykti

ciltacabtagene autoleucel · BCMA CAR-T
Not conducted (classical); lentiviral integration site analysis instead

ChondroCelect

characterised viable autologous cartilage cells · Autologous chondrocytes
Not conducted (per cell-based product guideline)

Ebvallo

tabelecleucel · EBV-specific allogeneic T cells
Not conducted (ICH S6(R1)); non-genetically engineered cells

Encelto

revakinagene taroretcel · CNTF (encapsulated RPE cell implant)
Done: ISO-10993 battery (bacterial, mammalian cell, mouse micronucleus on device extracts), negative

Gintuit

allogeneic cultured keratinocytes and fibroblasts in bovine collagen · Allogeneic keratinocytes + fibroblasts
Not conducted (nature of product and clinical experience)

Holoclar

autologous corneal epithelial cells containing limbal stem cells · Autologous limbal stem cells
Not conducted (classical); in vitro karyotype analysis of cells

Kymriah

tisagenlecleucel · CD19 CAR-T
Not conducted (classical); lentiviral integration site analysis on 14 donor products

Lantidra

donislecel · Allogeneic pancreatic islets
Not conducted

Laviv

azficel-T · Autologous fibroblasts
Not conducted (autologous nature, prior human experience)

MACI

autologous cultured chondrocytes on porcine collagen membrane · Autologous chondrocytes
Not conducted on cells; four studies on collagen membrane were non-mutagenic

Omisirge

omidubicel · Expanded cord blood HPC
No standard genotox; cytogenetic/karyotype analyses of CF and NF showed no clonal aneuploidy

Provenge

sipuleucel-T · PAP-GM-CSF (autologous APC)
Not conducted (autologous nature of product)

Rethymic

allogeneic processed thymus tissue · Allogeneic thymus tissue
Not conducted

Ryoncil

remestemcel-L · Allogeneic BM-MSC
Not conducted (not warranted)

Spherox

spheroids of autologous matrix-associated chondrocytes · Autologous chondrocyte spheroids
Not conducted (per cell-based product guideline)

StrataGraft

allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen · Allogeneic keratinocytes + fibroblasts
Not conducted

Tecelra

afamitresgene autoleucel · MAGE-A4 TCR-T
Not conducted (no test models or relevant species); integration site analysis showed polyclonal products, no selective insertion

Tregzi

allogeneic Treg immunotherapy with HSPC and T cells (Orca-T) · Allogeneic Treg + HSPC + Tcon
Not conducted

Yescarta

axicabtagene ciloleucel · CD19 CAR-T
Not conducted; literature review of retroviral-transduced T-cell transformation risk instead

Zalmoxis

allogeneic T cells modified with HSV-TK / dLNGFR (nalotimagene carmaleucel) · HSV-TK suicide-gene T cells
Not conducted; in vitro retroviral integration site analysis instead

Zemcelpro

dorocubicel · UM171-expanded cord blood CD34+
Done for residual UM171 only (Ames, CHO micronucleus negative) plus cytogenetics of treated cells; none for cells

Summary across all 27 cell therapies →