Academic Breakthrough | Lu Daopei Medical Team Publishes Groundbreaking Clinical Study in the British Journal of Haematology

In a significant achievement for the Lu Daopei Medical Team, a pioneering clinical research paper titled “A safety and efficacy study of allogeneic haematopoietic stem cell transplantation for refractory and relapsed T-cell acute lymphoblastic leukaemia/lymphoblastic lymphoma patients who achieved complete remission after autologous CD7 chimeric antigen receptor T-cell therapy” has been published in the renowned British Journal of Haematology (IF=5.1). The study, authored by Dr. Cao Xingyu with Prof. Lu Peihua as the corresponding author, focuses on the promising potential of bridging allo-HSCT for R/R T-ALL and T-LBL patients who achieved complete remission (CR) following autologous CD7 CAR-T therapy.

Research Background:

T-cell malignancies, such as T-ALL and T-LBL, are known for their aggressive nature and high treatment resistance. For patients with refractory or relapsed T-ALL/LBL (R/R T-ALL/T-LBL), traditional therapies offer limited success and poor prognoses. However, CD7 CAR-T therapy has emerged as a potential breakthrough, showing significant promise in treating these difficult-to-treat conditions, despite still being in the early stages of clinical trials. When followed by consolidation with allo-HSCT, patients who achieve CR with CD7 CAR-T therapy are offered a real chance at long-term remission.

Study Methodology:

This retrospective study analyzed R/R T-ALL and T-LBL patients who received NS7 CAR-T therapy, followed by allo-HSCT consolidation between November 2020 and January 2023 at Lu Daopei Hospital. The study examined various factors, including patient age, pre-transplant CAR-T cell copy number, and different CAR-T dosing regimens, to evaluate their impact on transplant outcomes. The results were compared to those of 124 patients who achieved CR via chemotherapy followed by allo-HSCT.

Key Findings:

The study included 34 R/R T-ALL/T-LBL patients who achieved CR after NS7 CAR-T therapy and subsequently underwent allo-HSCT. The median interval between CAR-T therapy and transplant was 57.5 days. Notably, 47.1% of patients had primary refractory disease, while 52.9% had relapsed disease. Post-CAR-T infusion, cytokine release syndrome (CRS) occurred in 33 patients, with 94.1% experiencing Grade 1–2 CRS. Fortunately, no patients developed immune effector cell-associated neurotoxicity syndrome (ICANS).

At 28 days post-CAR-T, 31 patients achieved MRD-negative CR, while 3 patients had MRD-positive CR. The study also found that patients with ≤20% bone marrow blasts prior to transplant had a 0% relapse rate at 18 months post-transplant. When compared with chemotherapy-based CR patients, the 2-year overall survival (OS) rates were similar: 61.9% for the CD7 CAR-T group vs. 67.6% for the chemotherapy group. Additionally, the 2-year leukemia-free survival (LFS) rates were nearly identical (62.3% vs. 62.0%).

Of particular note, patients aged ≤14 years who received CD7 CAR-T therapy had an outstanding 87.5% 2-year OS and LFS. The results suggest that CD7 CAR-T therapy followed by allo-HSCT can offer a safe and effective alternative for R/R T-ALL/T-LBL patients who are ineligible for traditional treatments.

Conclusion:

The study concludes that the combination of CD7 CAR-T therapy followed by allo-HSCT offers a promising and effective treatment approach for R/R T-ALL/T-LBL patients. The results were comparable to those achieved with chemotherapy and allo-HSCT, with no increase in non-relapse mortality, providing an invaluable treatment option for patients with limited therapeutic options. The study's findings offer hope for long-term remission and survival, especially in high-risk patients who undergo timely consolidation with allo-HSCT.

Impact and Future Outlook:

The publication of this groundbreaking research in British Journal of Haematology is a testament to the dedication and expertise of the Lu Daopei Medical Team. This achievement highlights the hospital's ongoing efforts in advancing the treatment of blood disorders and their significant contributions to the global medical community. It underscores the potential of CD7 CAR-T therapy as a viable option for patients with R/R T-ALL/T-LBL and reflects the team's commitment to pushing the boundaries of hematological cancer treatment.