Phase I CARLYSLE trial data show CAR-T therapy obe-cel induces remission in severe refractory lupus with a favorable safety profile. Separate case report documents two successful pregnancies after dual-target CAR-T therapy with no transmission to infants.
Updated data from the phase I CaMMouflage trial showed CB-011, the first allogeneic anti-BCMA CAR-T therapy with immune cloaking, achieved an approximately 92% overall response rate in relapsed/refractory multiple myeloma. The 2026 Tandem Meetings also highlighted advances in EB-103, KITE-753, and LV20.19 CAR-T constructs across lymphoma and CLL. Separately, NXC-201 reported a 95% complete response rate in AL amyloidosis.
A phase II trial of TAK-007 CAR-NK therapy in R/R B-cell NHL showed a 60.9% overall response rate. Preclinical CAR-NKT therapy eliminated endometrial tumors in models. Optimized costimulatory domains (2B4-DAP12) boosted CAR-NK tumor killing.
CAR-T toxicity management is shifting toward phenotype- and mechanism-based intervention. Key issues include CRS, ICANS, IEC-HS, and long-term risks of cytopenia and infection.
Kyverna Therapeutics reports positive long-term follow-up results for its CAR-T therapy miv-cel in generalized myasthenia gravis, with plans to submit a biologics license application in the first half of 2026. The company has $279.3 million in cash providing runway into 2028 to fund launch and Phase 3 trials.
The 2026 Tandem Meetings featured new data on CAR-T, allogeneic transplantation, and supportive care. Highlights included early efficacy signals for EB-103, KITE-753, Orca-T, and NXC-201, plus comparative cardiovascular safety data for lisocabtagene maraleucel.
A phase 1 trial shows denileukin diftitox administered before CAR-T therapy has a favorable safety profile and encouraging efficacy in high-risk DLBCL patients, with an 86% overall response rate and 77% one-year progression-free survival. The treatment demonstrated consistent regulatory T-cell depletion, supporting its immunomodulatory mechanism. Larger controlled studies are needed to confirm these preliminary findings.
Real-world data from over 300 large B-cell lymphoma patients treated with axicabtagene ciloleucel show response rates and survival outcomes remarkably similar to pivotal trial results, with 86% overall response rate and 74% one-year survival.
The FDA has granted fast track designation to QRX003 for Netherton Syndrome and IBI3003 for relapsed or refractory multiple myeloma, while also accepting regulatory applications for other therapies addressing serious conditions with unmet medical needs.
Citius Pharmaceuticals reported $3.9 million in first revenue from LYMPHIR's December 2025 launch for cutaneous T-cell lymphoma, while subsidiary Citius Oncology announced positive Phase 1 data showing 86% response rate when LYMPHIR was administered prior to CAR-T therapy in high-risk lymphoma patients.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07403812 |
Assessing DCog Short for Neurotoxicity in CAR-T |
NOT_YET_RECRUITING | NA |
| NCT07390071 |
Multimodal Telerehabilitation in Patients Undergoing CAR-T Cell Immunotherapy |
RECRUITING | NA |
| NCT06706102 |
Temporal Characterization of Extracellular Vesicles During Cellular Therapy Using CAR-T Cells and During the Occurrence of Immune Effector Cell-Associated Neurotoxicity Syndrome |
RECRUITING | PHASE4 |
| NCT06703216 |
Pre-emptive Anakinra for Cytokine Event Reduction |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT06352866 |
Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to tx w/ Teclistamab in RRMM |
WITHDRAWN | PHASE2 |
| NCT05643092 |
Biomarker and Imaging Package Study in Immune Effector Cell-Associated Neurotoxicity Syndrome |
RECRUITING |
