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 2 trial in high-risk smoldering multiple myeloma found all 20 patients treated with cilta-cel became MRD-negative within two months and remained so after 15.3 months. No disease progression, death, dose-limiting toxicities, or high-grade side effects were observed.
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.
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.
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.
New research addresses CAR T-cell therapy safety through a venetoclax-controlled on-off switch and a prospective study identifying neurotoxicity risk markers in pediatric patients with acute lymphoblastic leukemia.
T-cell immunotherapies including CAR T-cell therapy and T-cell engagers are expanding cancer treatment options but present significant cardiovascular risks and operational complexities requiring coordinated multidisciplinary management.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07375628 |
Neurological and Cognitive Dysfunction Following CAR-T Treatment. ICANS and Beyond |
NOT_YET_RECRUITING | |
| NCT07169487 |
Adjunctive Methylene Blue for Immunotherapy-related CRS and ICANS: Phase I Study |
RECRUITING | PHASE1 |
| NCT04975555 |
Study to Evaluate the Role of Siltuximab in Treatment of Cytokine Release Syndrome (CRS) and Immune Effector Cell Associated Neurotoxicity (ICANS) Related to CAR-T Cell Therapy |
ACTIVE_NOT_RECRUITING | PHASE2 |
