CAR-T and Cellular Therapy Promises Long-Lasting Lupus Remission
Key Questions
What remission rates have been reported with CAR-T therapies like obe-cel in severe SLE?
Obe-cel achieved remission in 5 out of 6 patients with severe SLE, allowing them to remain off medications for 18 months or longer. A meta-analysis across studies found 76% medication-free remission in SLE patients overall.
Which new allogeneic CAR-T options have received IND clearance for lupus?
ALLO-329 and FT-839, a dual CD19/CD38-targeted therapy, have gained IND clearance. Additionally, a CIRM grant supports development of an off-the-shelf CAR-NKT platform that may apply to lupus.
What regulatory designations has AbelZeta's C-CAR168 received for refractory lupus?
C-CAR168, a dual CD20/BCMA-targeted CAR-T, received EMA PRIME designation and FDA RMAT status. Early data showed a 77.8% renal response rate without background immunosuppression.
Why did Roche drop its CD19xCD3 TCE for SLE?
Roche discontinued the TCE due to insufficient characteristics but reaffirmed its commitment to cell therapies through Poseida's BCMAxCD19 CAR-T program.
What does the EULAR 2026 recap indicate about CAR-T durability in lupus?
The recap noted low relapse rates, with only 12% relapse in Erlangen data and 1 out of 28 patients relapsed overall, alongside discussion of BCMA rescue strategies for managing relapses.
What was the outcome for Vietnam's first CAR-T patient with refractory SLE and LN?
The patient achieved a good response despite experiencing cytokine release syndrome, marking the first use of CAR-T for this indication in the country.
What funding supports mechanistic studies on CAR-T in autoimmune diseases?
The Lupus Research Alliance and Genentech are funding three mechanistic studies, while Lili Yang received a $7.49 million CIRM grant for an off-the-shelf CAR-NKT platform.
What does the PLOS Medicine review cover regarding CAR-T in autoimmune diseases?
The review by Bachl, Hagen, and Schett provides a comprehensive overview of CAR-T applications in autoimmune diseases, including trial data and mechanisms.
Major advances: obe-cel (5/6 remission in severe SLE, off meds 18+ months), Cleveland Clinic drug-free remission >1 year in refractory LN, teclistamab major responses in refractory SLE. New allogeneic options: ALLO-329 (first-in-human) and FT-839 (dual CD19/CD38) gain IND clearance. A new meta-analysis reports 76% medication-free remission in SLE, with longer disease duration reducing remission rates. EULAR 2026 recap covers relapse biology (12% in Erlangen, BCMA rescue) and durability (1/28 relapsed). LRA/Genentech fund three mechanistic studies. Sheikh Research highlights trial participation barriers. A new article provides detailed overview of CAR-T for autoimmune disease in China, including trial enrollment and qualification criteria. An inspirational piece highlights researchers behind CAR-T and other breakthroughs. AbelZeta's C-CAR168 (dual CD20/BCMA-targeted CAR-T) received EMA PRIME designation for refractory lupus, following FDA RMAT; early data shows 77.8% renal response without background immunosuppression. Now, FDA has cleared C-CAR168 for a registrational Phase II trial in refractory LN, a concrete step toward potential approval. A PLOS Medicine review by Bachl, Hagen, and Schett offers a comprehensive overview of CAR-T in autoimmune diseases. A new case report from Vietnam describes the country's first CAR-T patient with refractory SLE and LN achieving good response despite CRS. Another case report shows blinatumomab (BiTE) efficacy in dermatomyositis/SLE overlap after HSCT, expanding T-cell engager approaches. Roche drops its CD19xCD3 TCE for SLE due to insufficient characteristics, but reaffirms cell therapy commitment via Poseida's BCMAxCD19 CAR-T, signaling TCE hurdles and continued CAR-T momentum. A new CIRM grant funds off-the-shelf CAR-NKT platform (Lili Yang) that could apply to lupus, expanding allogeneic options.