Relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL) carries an extremely poor prognosis, with long-term survival rates of only 10%–20%. The advent of NS7 CAR-T, a novel naturally selected CD7-directed CAR-T therapy that requires no additional genetic modification, has brought a transformative breakthrough to the treatment of these diseases.

At the 2026 European Hematology Association (EHA) Congress, Professor Zhang Xian from Lu Daopei Hospital delivered an oral presentation reporting the latest long-term follow-up data from 171 patients treated with NS7 CAR-T. This represents the largest CD7 CAR-T cohort study reported worldwide to date. During the meeting, Oncology Frontier – Hematology Frontier invited Professor Zhang to discuss the efficacy and safety profile of NS7 CAR-T, the optimal timing of allogeneic hematopoietic stem cell transplantation (allo-HSCT) following CAR-T therapy, individualized treatment strategies for high-risk populations, and future directions for further improving outcomes in this field.

Oncology Frontier – Hematology Frontier:

This study enrolled 171 patients with relapsed/refractory T-ALL/LBL and is among the largest long-term follow-up studies of CD7 CAR-T therapy. How do you interpret the nearly 90% MRD-negative remission rate and approximately 70% two-year overall survival achieved with NS7 CAR-T? What do these findings mean for the treatment landscape of relapsed/refractory T-ALL/LBL?

Professor Zhang Xian:

At the 2026 EHA Congress, our center presented an oral report retrospectively analyzing clinical outcomes from 171 patients with relapsed/refractory T-cell lymphoblastic lymphoma and acute T-cell lymphoblastic leukemia treated with naturally selected CD7 CAR-T therapy (NS7 CAR-T).

The data presented constitute the largest clinical cohort study of CD7 CAR-T therapy reported globally to date. Since 2020, our center has been utilizing naturally selected autologous CD7 CAR-T therapy, a platform that does not require additional genetic engineering of patients’ own T cells. This report summarizes outcomes from 171 of these patients.

The results demonstrated outstanding efficacy and a favorable safety profile. Among the 171 patients, the combined complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) rate exceeded 90%, while the MRD-negative complete remission rate reached 88%.

This therapy has brought a transformative breakthrough to the treatment of relapsed/refractory T-cell lymphoblastic lymphoma and acute T-cell lymphoblastic leukemia. Prior to its availability, patients entering the relapsed or refractory setting faced extremely poor outcomes, with long-term survival rates of only 10%–20%. Even allogeneic hematopoietic stem cell transplantation offered limited salvage success.

With NS7 CAR-T, however, patients who achieve both hematologic remission and MRD negativity and subsequently undergo allo-HSCT within three months can achieve long-term disease-free survival beyond two years in more than 70% of cases. This treatment strategy offers renewed hope for patients who previously had very limited prospects for long-term survival.

Oncology Frontier – Hematology Frontier:

The study showed that bridging allo-HSCT following CAR-T therapy significantly improved long-term overall survival and progression-free survival, with benefits also observed among previously transplanted and other high-risk patients. Based on your experience, which patients should most strongly be considered for transplantation, and how should the optimal timing between CAR-T and allo-HSCT be determined?

Professor Zhang Xian:

Although we hope CAR-T therapy can ultimately achieve cure on its own, clinical observations indicate that remission is not always durable following CD7 CAR-T treatment.

Specifically, CAR-T cell levels measured by flow cytometry begin to decline noticeably two to three months after infusion. Between three and six months after treatment, a considerable proportion of patients experience disease relapse. For patients with relapsed/refractory T-cell lymphoblastic lymphoma and acute T-cell lymphoblastic leukemia—both extremely high-risk diseases—relapse often means losing the opportunity for additional CD7 CAR-T therapy or allogeneic transplantation.

For this reason, we recommend that patients proceed to allogeneic hematopoietic stem cell transplantation as soon as possible after achieving complete remission with CD7 CAR-T, ideally within three months. Our follow-up data support this recommendation, showing that this sequential treatment strategy achieves two-year overall survival and progression-free survival rates exceeding 70%, representing highly encouraging clinical outcomes.

Subgroup analyses further demonstrated that patients harboring high-risk fusion genes, including SIL::TAL1, PICALM-AF10, and SET-CAN, or those carrying TP53 mutations, should undergo transplantation as early as possible after achieving MRD-negative complete remission with CD7 CAR-T therapy.

For the particularly high-risk subgroup with SIL::TAL1-positive disease, we recommend proceeding to transplantation within one to two months after remission is achieved. These conclusions are supported by extensive clinical data and long-term validation.

Oncology Frontier – Hematology Frontier:

The study also included traditionally high-risk patients, such as those with TP53 mutations, SIL::TAL1 fusions, and relapse following previous transplantation. What therapeutic potential has NS7 CAR-T demonstrated in these populations? Are there plans to further explore CAR-T combined with transplantation or other maintenance strategies to reduce relapse risk?

Professor Zhang Xian:

SIL::TAL1 fusion positivity, TP53 mutations, and post-transplant relapse are all associated with extremely poor prognosis.

Historically, once these patients entered the relapsed or refractory stage, long-term survival was virtually nonexistent regardless of whether chemotherapy, targeted therapy, or allogeneic hematopoietic stem cell transplantation was employed.

Our data demonstrate that CD7 CAR-T therapy followed by allo-HSCT can significantly improve outcomes in these ultra-high-risk populations, enabling more than half of these patients to achieve long-term survival.

From a clinical perspective, we recommend that such patients proceed to transplantation within approximately two months after receiving CD7 CAR-T therapy. For patients who relapse following a previous transplant, decision-making is more complex because they often present with severe bone marrow suppression and prolonged cytopenias. In these cases, the timing of a second transplantation must be carefully evaluated and individualized by the treating clinical team.

Despite these encouraging advances, we have also observed that outcomes for patients carrying these high-risk features remain inferior to those achieved by patients without such adverse prognostic factors, even after CD7 CAR-T therapy and transplantation.

How to further optimize treatment strategies and improve long-term outcomes for these ultra-high-risk patients remains an important area for future investigation.

Expert Profile

Professor Zhang Xian

Lu Daopei Hospital
Hebei Yanda Lu Daopei Hospital

Director, Department of General Hematology and Immunotherapy I
Chief Physician, MD

Professor Zhang serves as a Committee Member of the Hematology Physicians Branch of the Chinese Medical Doctor Association; Committee Member of the Hematopoietic Stem Cell Transplantation and Cellular Therapy Group under the Hematologic Oncology Committee of the Chinese Anti-Cancer Association; Committee Member of the Cellular Research and Therapy Committee of the Chinese Research Hospital Association; Expert Committee Member of the Human Leukocyte Antigen Committee of the China Blood Transfusion Association; Member of the Leukemia Immunotherapy Collaborative Group of the China Hematology Specialty Alliance; Registered Physician of the CCPAP Program under the China Charity Federation; Committee Member of the Hematologic Malignancies Committee of the Beijing Anti-Cancer Association; Committee Member of the Red Blood Cell Disorders Committee of the Beijing Cancer Prevention and Treatment Society; Committee Member of the Multidisciplinary Lymphoma Care Committee of the Beijing Integrative Medicine Association; and Committee Member of the Lymphoma Committee of the Hebei Society of Hematology.