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CAR-T Therapy

Chimeric Antigen Receptor T-cell therapy — engineered T cells that recognize and kill target cells. A central theme across SDDS 2026, covered extensively in Session V (Rosenberg), Session V (Sadelain), Session V (June), and Session V (Panel).

Current State (2026)

  • 7 FDA-approved products: 5 against CD19, 2 against BCMA
  • 60,000 patients treated; CRS and ICANS routinely managed

  • Major remaining issues: autologous scale-out, access, cost of goods

Three Pioneers

PioneerKey ContributionInstitution
Steven RosenbergFather of cancer immunotherapy; IL-2, TIL, first human gene transfer, first CAR-T cancer regressionNCI
Michel SadelainArchitect of second-generation CAR; coined “CAR” and “living drugs”; first CD19 CAR-T trialColumbia (formerly MSK)
Carl JuneTisagenlecleucel (Kymriah); first FDA-approved gene therapy; Emily WhiteheadPenn

See also: steven-rosenberg, michel-sadelain, carl-june

Evolution

First Generation (zeta-only)

  • Prompt cytolysis → activation-induced cell death or anergy in real T cells

Second Generation (CD28-zeta or 4-1BB-zeta)

  • Sadelain’s key insight: co-stimulation must be built into the receptor
  • CD28: potent but short-lived; 4-1BB: persistent but slower — it was never about the costim domain, it was activation vs. co-stimulation balance

Next Generation Designs

  • 1XX — calibrated ITAM signaling (Sadelain); responses at 10M cells
  • HIT — HLA-independent TCRs; 10-50× lower antigen threshold (Sadelain)
  • Pre-TCR — thymocyte expansion biology; extreme potency (Sadelain)
  • Armored CARs — IL-18 secretion (June)
  • OR-gated dual-target — EGFR-vIII + IL-13Rα2 for GBM (June)
  • Multiplex CRISPR KOs — Regnase-1 + EGR2 (June)

Four Delivery Modes

  1. Ex vivo autologous — current standard
  2. Off-the-shelf allogeneic
  3. In vivo viral vectors IV — manufacturing CAR-T inside the patient (China-first)
  4. LNP-mRNA — transient endogenous T-cell reprogramming

Beyond Cancer

  • Immune reset in autoimmunity (lupus, scleroderma) — ~300 active trials
  • CAR-Tregs for diabetes
  • Senolytic CAR-Ts for chronic inflammation
  • Neuroinflammation/microglia in Alzheimer’s (very early)

Key Unsolved Problems

  • Solid tumors: trafficking, immunosuppressive microenvironment, persistence, target selection
  • The 90% problem: solid epithelial cancers cause ~90% of cancer deaths; neoantigen-targeted approaches (Rosenberg) are the leading strategy