ProblemManufacturing bottleneck
ApproachesIn vivo / off-the-shelf allogeneic
SafetySwitchable, no lymphodepletion
GoalScalable access
Early phasePhase 1
LB2501
In vivo CD19/CD20 dual CAR-T · B-cell NHL · Fan
- CAR-encoding material delivered directly to the patient (in vivo)
- Median time from consent to infusion 17.5 days
- Higher dose (n=6): 100% overall response, 83.3% complete
- CRS grade 1 to 2 only; no ICANS, no dose-limiting toxicity
Why it matters: Removes apheresis, lymphodepletion and weeks of manufacturing, the main barriers to access.
Early phasePhase 1a
REVSTAR-123
RevSTAR-123 / AVC-201 · NCT05949125 · LBA5007 · Wermke
- Switchable allogeneic CD123 CAR-T for relapsed/refractory AML
- Complete remissions reported
- No graft-versus-host disease and no ICANS
- A continuous targeting module gives an on/off safety switch
Why it matters: An off-the-shelf, controllable platform for AML, where on-target toxicity has limited conventional CAR-T.
Early phaseProof of concept
BCMA CAR-T in ITP
LB5003 · Shu · autoimmune
- BCMA CAR-T in refractory primary ITP
- 8 dosed, 4 evaluable, all in complete response, 1 relapse at 9 months
Why it matters: Shows cellular therapy reaching benign autoimmune disease, not only cancer.