Autoimmune Competitive Landscape · CD19 & BCMA · In Vivo & Ex Vivo · Feb 2026
| Company | Ticker | Product | Target | Approach | Phase | Indications | Stock / Valuation | Key Data |
|---|---|---|---|---|---|---|---|---|
| Kyverna Therapeutics | KYTX | KYV-101 (miv-cel) | CD19 | Ex vivo autologous | Phase 2 (registrational) | SPS, MG, lupus nephritis, SSc, myositis | $7.93 | KYSA-8 (SPS): positive registrational Ph2 data Dec 2025; BLA filing expected 2026; KYSA-6 (MG): positive Ph2 interim Oct 2025 |
| Cartesian Therapeutics | RNAC | Descartes-08 | BCMA | Ex vivo autologous (mRNA) | Phase 2b | Myasthenia gravis | $6.84 | Ph2b RCT in MG: 33% achieved MSE at 6mo; BCMA-directed mRNA CAR (transient); Nature Medicine Jan 2026 |
| Cabaletta Bio | CABA | CABA-201 (rese-cel) | CD19 | Ex vivo autologous | Phase 1/2 | SLE, myositis, SSc, lupus nephritis, pemphigus | $2.51 | RESET trials: Ph1/2 data in myositis (2025); SLE, SSc, LN data expected H1 2026 |
| Novartis (Erlangen) | NVS | Kymriah (academic) | CD19 | Ex vivo autologous | Phase 1/2 (CASTLE) | SLE, SSc, myositis (academic) | $97.50 | CASTLE basket trial: Ph1/2 published Nature Medicine Jan 2026; Schett group academic use |
| Bristol-Myers Squibb | BMY | BMS-986353 (NEX-T) + OTX-201 | CD19 | Ex vivo (NEX-T) + In vivo circRNA/LNP (Orbital) | Phase 1 (NEX-T) / Preclinical (OTX-201) | SLE, SSc, myositis, MS, autoimmune | $56.20 | Breakfree-1: Ph1 data in 71 autoimmune pts (ACR 2025); NEX-T 5-day manufacturing; Acquired Orbital Therapeutics Oct 2025 for $1.5B; OTX-201: CD19 circular RNA in vivo CAR-T via targeted LNP; IND-enabling |
| Johnson & Johnson | JNJ | JNJ-90014496 | CD19/CD20 | Ex vivo autologous | Phase 1b | B-cell NHL (autoimmune exploratory) | $155.30 | Dual CD19/CD20 bispecific CAR-T; Ph1b in LBCL; autoimmune application exploratory |
| AbbVie / Capstan | ABBV (acquired) | CPTX2309 (tLNP) | CD19 | In vivo tLNP | Phase 1 (healthy volunteers) | Autoimmune (B-cell mediated) | Acquired $2.1B | Acquired by AbbVie Jun 2025 for $2.1B; tLNP mRNA platform; Ph1 in healthy volunteers initiated; Penn spinout |
| AstraZeneca / EsoBiotec | AZN (acquired) | In vivo lentiviral | CD19 | In vivo lentiviral | Phase 1 (first patient dosed) | Autoimmune + Oncology | Acquired $1B | Acquired by AZ Mar 2025 for up to $1B ($425M upfront); first patient data presented Jul 2025 |
| Umoja Biopharma | Private | UB-VV111 | CD19 | In vivo lentiviral (VivoVec) | Phase 1 (FDA Fast Track) | B-cell malignancies (autoimmune planned) | Private | First FDA-cleared in vivo CAR-T IND (2024); Ph1 launched Mar 2025; FDA Fast Track Sep 2025 |
| Aera Therapeutics | Private | AERA-109 | CD19 | In vivo tLNP | Preclinical (IND mid-2026) | SLE, MG, SSc, myositis | Private ($193M raised) | Complete B-cell depletion in NHP; single IV injection; no lymphodepletion; IND-enabling studies; ASH 2025 poster |
| Eli Lilly / Orna | LLY (acquired) | Orna-252 (oRNA/LNP) | CD19 | In vivo oRNA/LNP | Preclinical | Autoimmune (B-cell mediated) | Acquired $2.4B | Acquired by Lilly Feb 2026 for $2.4B; oRNA circular RNA platform; IND expected 2027 |
| Gilead / Kite (Interius) | GILD (acquired) | INT2104 | CD19 | In vivo lentiviral | Preclinical | Autoimmune diseases | Acquired $350M | Acquired by Gilead/Kite Aug 2025 for $350M; in vivo lentiviral CAR-T; autoimmune focus |
| Fate Therapeutics | FATE | FT819 | CD19 | Ex vivo allogeneic iPSC | Preclinical | Oncology (autoimmune potential) | $2.10 | iPSC-derived allogeneic CAR-T; autoimmune potential |
Purple-highlighted rows = in vivo approaches.