Press release | 7th May 2025

What’s next for CAR-Ts? Haemato-oncology breakthroughs to track at ASCO 2025

Gilead’s KITE-363: Advancing dual-targeted CAR-T for B-cell lymphoma

A Phase 1 study of KITE-363 anti-CD19/CD20 chimeric antigen receptor (CAR) T-cell therapy in patients (pts) with relapsed/refractory (R/R) B-cell lymphoma (BCL) (link)

Affiliation: Gilead

• R/R B-cell lymphoma remains a key focus for CAR-T innovation and while anti-CD19 CAR-Ts show strong efficacy, durability is limited by immune escape, particularly via loss of CD19 expression
  • As the field advances, next-generation constructs aim to improve durability and reduce relapse

• Gilead’s KITE-363, now in Phase 1, is a dual-targeting CAR-T designed to target both CD19 and CD20, to mitigate antigen escape and improve persistence
  • Early data will offer insights into performance in heavily pre-treated patients and its place in the therapeutic landscape

• With growing competition in B-cell malignancies, durability of response is becoming a key differentiator; therapies like KITE-363 may offer improved durability, but broader adoption will depend on demonstrating clinical benefit alongside safety and scalability

CAR-T for AL amyloidosis? ImmixBio’s Nxc-201 brings first US data to ASCO 2025

Safety and efficacy data from Nexicart-2, the first US trial of CAR-T in R/R light chain (AL) amyloidosis, Nxc-201 (link)

Affiliation: Immix Biopharma

• Light Chain (AL) amyloidosis is a rare, life-threatening plasma cell disorder often seen in patients with multiple myeloma, with both conditions share underlying mechanisms related to abnormal plasma cell activity
  • This connection has spurred growing interest in adapting therapies developed for multiple myeloma, such as BCMA-targeted CAR-T cell treatments, for use in AL amyloidosis
    • Despite progress in frontline management, amyloidosis has long lacked effective targeted therapies beyond initial treatment

• Given the overlapping biology with myeloma, interest has grown in repurposing BCMA-directed CAR-T therapies for AL amyloidosis and at ASCO 2025, early safety and efficacy data from ImmixBio’s Nxc-201 will be presented
  • Beyond clinical signals, this study could help answer key questions, including can patients tolerate CAR-T?
• As CAR-T expands beyond malignancies, Nexicart-2 represents a pivotal step in understanding how cell therapy might be adapted for rare, non-malignant plasma cell disorders with high unmet need

Off-the-shelf CAR-T: advancing allogeneic CD19 therapy for B-ALL

A Phase 1 study of allogeneic anti-CD19 CAR-T therapy for patients with CD19+ relapsed/refractory acute B-lymphoblastic leukemia (link)

Affiliation: No industry sponsor

• Relapsed/refractory (R/R) acute B-lymphoblastic leukaemia (B-ALL) is an aggressive haematologic malignancy with limited long-term treatment options
  • Autologous anti-CD19 CAR-T therapies have shown initial promise, but were limited by challenges in access and manufacturing with allogeneic anti-CD19 CAR-T, which uses off-the-shelf donor-derived T-cells, offering a potential solution to these issues
• This Phase 1 study explores the potential of off-the-shelf CAR-T therapy to provide rapid, scalable, and consistent treatment
  • By decoupling manufacturing from a patient’s health status and using healthy donor T-cells, allogeneic platforms could offer improvements in access, cost reduction, and faster time-to-treatment for high-risk B-ALL patients
• As CAR-T evolves, allogeneic strategies may become essential to achieving commercial viability and broader clinical impact across haematologic cancers

Anti-BCMA vs BiTE: real-world data informing the next move in multiple myeloma

Real-world comparison of anti-BCMA vs anti-GPRC5D BiTE therapy in relapsed/refractory multiple myeloma without prior CAR-T cell exposure (link)

Affiliation: No industry sponsor

• Relapsed/refractory multiple myeloma (RRMM) is a complex and difficult-to-treat disease, particularly for patients who are ineligible for or have not yet received CAR-T therapies
• While anti-BCMA therapies have become central to RRMM treatment, their effectiveness can be limited by resistance or relapse, highlighting the need for alternative targets
• This real-world study compares the use of anti-BCMA and anti-GPRC5D bispecific T-cell engagers (BiTEs) in RRMM patients without prior CAR-T exposure
  • While results are yet to be presented, the growing interest in GPRC5D as a novel target hints at its potential to complement or even challenge BCMA-based approaches
• For patients with few options and for developers looking beyond crowded BCMA pipelines, GPRC5D-targeting BiTEs may open the door to broader and more durable T-cell–based strategies
  • As data mature, this could mark a meaningful shift in the RRMM landscape, with dual-targeting, sequencing, and combinatorial approaches moving to being the preferred option