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Atlas/Cell therapy/Zemcelpro/Risks

Zemcelpro: which risks did reviewers probe?

dorocubicel · UM171-expanded cord blood CD34+
Check my plan vs. these
Immune & cytokine safety
No immunogenicity/cytokine studies; DP2 not tested in vivo as GvHD expected in NSG mice from mature immune cells
“in vivo transplantation cannot be performed with DP2 due to an expected GvHD reaction in the NSG mice caused by mature immune cells in this fraction.”
✓ VerifiedEMA assessment report, p. 39Source ↗
Biodistribution & persistence
Not studied; cell distribution not evaluated, assumed like normal allogeneic stem cell transplant
“The distribution of the UM171-treated cells is not evaluated.”
✓ VerifiedEMA assessment report, p. 32Source ↗
Modality-specific risk
Unintended epigenetic changes from UM171 expansion; long-term engraftment/stemness; no long-term clinical safety data
“whether there are unintended epigenetic changes is not addressed.”
✓ VerifiedEMA assessment report, p. 37Source ↗

Same question, other cell therapies

Abecma

idecabtagene vicleucel · BCMA CAR-T
BCMA-specific IFN-γ release in vitro; CRS not modeled; expected depletion of normal plasma cells

Alofisel

darvadstrocel · Allogeneic adipose MSC
Low T-cell recognition and delayed NK elimination in vitro; immunocompetent rats showed rejection-type inflammation

Amtagvi

lifileucel · TIL therapy
No immunotox/cytokine studies; literature shows anti-CD3-activated TIL cytotoxicity specific to autologous tumor, not heterologous targets

Aucatzyl

obecabtagene autoleucel · CD19 CAR-T
No nonclinical CRS/ICANS model; CRS and neurotoxicity judged clinically manageable; CAT19 showed higher TNF-α in vitro/in vivo

Breyanzi

lisocabtagene maraleucel · CD19 CAR-T
In vitro CD19-specific IFN-γ, IL-2, TNF-α release; EGFRt allows cetuximab-mediated CAR-T depletion

Carvykti

ciltacabtagene autoleucel · BCMA CAR-T
CRS, TLS, MAS not investigated nonclinically; off-target CLDN9 binding seen only on overexpressing cells

ChondroCelect

characterised viable autologous cartilage cells · Autologous chondrocytes
Human/allogeneic chondrocytes caused immune response and poor repair in orthotopic model

Ebvallo

tabelecleucel · EBV-specific allogeneic T cells
No cytokine or immunogenicity studies; low alloreactivity verified in release testing; CD20 not expressed (rituximab interaction unlikely)

Encelto

revakinagene taroretcel · CNTF (encapsulated RPE cell implant)
Minipig/pig studies to 6 months showed no immune response to rhCNTF or cells; mild to moderate ocular inflammation

Gintuit

allogeneic cultured keratinocytes and fibroblasts in bovine collagen · Allogeneic keratinocytes + fibroblasts
No alloimmune response in vitro; indirect allorecognition not evaluated; xenogeneic reaction to subcutaneous injection in rabbits

Holoclar

autologous corneal epithelial cells containing limbal stem cells · Autologous limbal stem cells
No immunogenicity studies; no significant adaptive immune response in clinical setting

Kymriah

tisagenlecleucel · CD19 CAR-T
No cytokine/CRS studies; scFv bound only CD19 on 3550-protein array; no CD19 in human/cyno brain

Lantidra

donislecel · Allogeneic pancreatic islets
Allograft rejection without immunosuppression in mice; clinical HLA sensitization (donor-specific antibodies) risk

MACI

autologous cultured chondrocytes on porcine collagen membrane · Autologous chondrocytes
Inflammation likely due to defect creation and possible immune response to porcine membrane

Omisirge

omidubicel · Expanded cord blood HPC
Not assessed nonclinically (immunodeficient model); clinically GvHD dose-safety relationship flat

Provenge

sipuleucel-T · PAP-GM-CSF (autologous APC)
Autoimmune prostatitis induced in rats (mild to moderate); non-prostate PAP-expressing tissues not fully examined; no robust data on autoimmunity risk

Rethymic

allogeneic processed thymus tissue · Allogeneic thymus tissue
Donor-derived T cells declined as endogenous recipient T cells developed in rats; no dedicated immunotoxicity study

Ryoncil

remestemcel-L · Allogeneic BM-MSC
Low-level alloantibody formation in baboons; in vitro ceMSC suppress T cells and shift cytokines (IFNg, IL-10 up, TNFa down)

Spherox

spheroids of autologous matrix-associated chondrocytes · Autologous chondrocyte spheroids
No immunogenicity studies; enlarged popliteal lymph nodes in 2 sheep with allogeneic cells, possible immune response

StrataGraft

allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen · Allogeneic keratinocytes + fibroblasts
Xenogeneic response possible in immunocompetent animals, so athymic mice used; no immunogenicity studies reported

Tecartus

brexucabtagene autoleucel · CD19 CAR-T
CRS, neurotoxicity, MAS not investigated nonclinically; considered general CAR-T effects

Tecelra

afamitresgene autoleucel · MAGE-A4 TCR-T
In vitro cytokine-release assay for cytokine-storm risk, no concerns; no immunogenicity studies (wild-type human TCR)

Tregzi

allogeneic Treg immunotherapy with HSPC and T cells (Orca-T) · Allogeneic Treg + HSPC + Tcon
Tregs suppress Tcon activation via contact and IL-2 inhibition; GVHD and weight loss in mice from Tcons; no cytokine release or immunotoxicity studies

Yescarta

axicabtagene ciloleucel · CD19 CAR-T
CRS, TLS, MAS deemed not investigable nonclinically; CD19-dependent cytokine release in vitro

Zalmoxis

allogeneic T cells modified with HSV-TK / dLNGFR (nalotimagene carmaleucel) · HSV-TK suicide-gene T cells
GvHD is the key immune risk; no antigenicity/immunotoxicity studies; GCV suicide gene as mitigation

Laviv

azficel-T · Autologous fibroblasts
Not stated in public reviews

Summary across all 27 cell therapies →