At the recent European Alliance of Associations for Rheumatology (EULAR) 2024 conference, industry sponsors presented preliminary data from ongoing, early-stage clinical trials evaluating CAR T-cell assets in autoimmune diseases, including systemic lupus erythematosus (SLE) and lupus nephritis (LN). While the overall results gave early indications of the potential ability of CAR T-cell assets in achieving an immune reset and potentially help patients achieve drug-free remission, reports of relapse post-infusion have drawn cautious optimism. However, there is also strong potential for this market to grow, with China emerging as a key leader, according to GlobalData, a leading data and analytics company.

Kyverna Therapeutics’ KYV-101 exhibited disease control at the follow-up period, with six of the seven patients with LN not requiring immunosuppressants and two of these patients having completed at least six months post-infusion. Results from Cabaletta Bio’s CABA-201 RESET-SLE trial indicated an improvement in the SLE Disease Activity Index 2000 (SLEDAI-2K) score and resolution of vasculitis, arthritis, and hematuria within four weeks post-infusion in one patient with SLE, with ongoing taper from prednisone 10mg per day.

Preliminary data from JW Therapeutics’ JWCAR029 (relmacabtagene autoleucel) also suggested efficacy; at four-month follow-up of three patients in the low-dose group, a reduction in Safety of Estrogens in Lupus Erythematosus National Assessment–SLEDAI (SELENA-SLEDAI) scores was observed, with all three patients achieving SLE responder index (SRI)-4, while two patients reaching lupus low disease activity status (LLDAS).

iCell Gene Therapeutics’ BCMA CD19 cCAR T cells also delivered promising results that demonstrated SLE patients being free of lupus medication with no relapses at a mean follow-up period of 20 months and in LN patients at a mean follow-up period of 16 months.

Vinie Varkey, Healthcare Analyst at GlobalData, comments: “The potential of CAR T-cells in achieving drug-free remission in patients with autoimmune diseases such as SLE and LN is a key focus that pharma companies continue to explore. And the results that were presented at EULAR 2024 from ongoing clinical trials indicate a movement in the right direction for these assets in this disease space.”

While the general sentiment over these results has been positive, episodes of relapses among patients have drawn an air of caution, such as in the case of one patient who received KYV-101 and relapsed five months post-infusion.

Varkey continues: “The objective of CAR T-cell assets in patients with autoimmune diseases is to achieve drug-free remission, which itself represents as a very high target to meet for any treatment modality. Given the promise of CAR T-cells in oncology, there is a strong belief in this strategy, along with a concerted action from industry and academic players to achieve similar results in autoimmune indications such as SLE and LN. So anytime a relapse is reported, there will be an element of caution exercised by multiple stakeholders.”

As per GlobalData’s Pharmaceutical Intelligence Centre (PIC), of the 18 CAR T-cell assets currently in pipeline clinical development for SLE and LN, 50% of pipeline assets are being evaluated in China.

Varkey adds: “This trend indicates the emergence of China as a leader in the development of CAR T-cell assets within the autoimmune disease space. The trend also highlights the opportunity for big pharma companies to partner with companies conducting clinical trials in China to propel the growth of the CAR T-cell modality on a broader geographical scale.”

Clinical developments and commercial partnerships within the CAR T-cell space will be crucial to meet the unmet needs that exist within the SLE and LN disease space. Key opinion leaders (KOLs) interviewed by GlobalData have highlighted the need for agents that can help patients, especially those with refractory forms of the disease, into remission without the need for these patients to be on traditional steroid and immune-suppressive therapies.

Varkey concludes: “As these innovator modalities continue along the path of development, clinical milestones achieved during this process will be seen as key moments that will propel the growth of this market. Achieving drug-free remission would represent a transformative, paradigm-shifting moment in the care of patients with SLE and LN.”