On August 22–23, 2025, the 13th Lu Daopei Hematology Conference was held in Beijing, co-hosted by the Beijing Health Promotion Association and the Guangzhou Hongmian Oncology & Rare Disease Public Welfare Foundation, and organized by the Beijing Lu Daopei Institute of Hematology. This high-level academic event gathered top hematology experts from around the world, focusing on hematopoietic stem cell transplantation, cellular therapy, and precision diagnosis and treatment of hematologic malignancies. During the meeting, Professor Junfang Yang of Hebei Yanda Lu Daopei Hospital delivered an excellent lecture on the “Clinical Application Experience of CD7-Targeted CAR-T Cell Therapy in Hematologic Malignancies.” Hematology Frontier summarized the key points to provide practical insights for clinical management.


Introduction

CD7 is a single-chain transmembrane glycoprotein expressed on immature T cells, NK cells, and some leukemia/lymphoma cells, and serves as a major marker for hematologic malignancies. Its high expression in T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/T-LBL), peripheral T-cell lymphoma (PTCL), and some cases of acute myeloid leukemia (AML) makes it an important therapeutic target. Drawing on clinical experience, Professor Yang provided a systematic overview of CD7-targeted chimeric antigen receptor T-cell (CD7 CAR-T) therapy in patients with relapsed/refractory hematologic malignancies.


1. Overview of CD7 as a Therapeutic Target

CD7 is a single-chain transmembrane glycoprotein expressed primarily on immature T cells, NK cells, and certain leukemia/lymphoma cells. Its presence in T-ALL, T-cell lymphomas, and AML makes it a critical therapeutic target and has paved the way for novel treatments. CD7 CAR-T cell development includes three main approaches: autologous CD7 CAR-T, donor-derived CD7 CAR-T, and universal CD7 CAR-T (UCAR-T). Autologous CD7 CAR-T uses the patient’s own T cells but may risk malignant T-cell contamination, leading to treatment failure, though it carries a lower risk of graft-versus-host disease (GVHD). Donor-derived CD7 CAR-T uses lymphocytes from a healthy donor, producing a more consistent product. Universal CD7 CAR-T is an ‘off-the-shelf’ therapy, overcoming GVHD and host-versus-graft responses while extending in-vivo persistence.


2. CD7 CAR-T in T-ALL/T-LBL

T-ALL/T-LBL are aggressive T-cell malignancies characterized by rapid proliferation, high tumor burden, and often mediastinal masses or pleural effusions. Over 95% of cases express CD7, making it an ideal target. Clinical practice confirms that CD7 CAR-T is both safe and effective in these settings. The NS7CAR product is a ‘naturally selected’ CD7 CAR-T therapy that does not require additional gene editing to block CD7 expression. In a Phase II trial of 20 patients who had failed ≥2 prior lines, 16 of 17 achieved MRD-negative CR at day 28. Lu Daopei Hospital’s single-center study reported a 94.4% MRD-negative rate in bone marrow and 78.1% ORR in extramedullary disease with mostly mild CRS.


3. CD7 CAR-T in PTCL

Relapsed/refractory PTCL carries a poor prognosis. CD7 expression rates vary by subtype, including 50% in PTCL-NOS and 57% in AITL. Five patients with CD7+ R/R PTCL were treated with NS7CAR-T; three achieved CR, one PR, and one NR, with only mild CRS and no neurotoxicity reported.


4. CD7 CAR-T in AML

About 30% of AML patients have CD7+ blasts. In a study of 10 treated patients, 7 achieved CR (6 MRD-negative), though three were non-responders with CD7 antigen loss. CRS was mild to moderate and no neurotoxicity occurred.


5. Development of Universal CAR-T (UCAR-T)

Universal CD7 CAR-T offers rapid availability and consistent quality. Phase I data showed 82% ORR and 75% MRD-negative CR in leukemia patients, with no ≥grade 3 CRS or GVHD. In a multicenter study of 62 patients, 64.4% achieved CR, most MRD-negative, with manageable CRS and minimal neurotoxicity.


6. Summary of Clinical Experience

Between November 2020 and July 2025, Lu Daopei Hospital performed 450 CD7 CAR-T infusions across T-ALL/T-LBL, PTCL, and AML. Autologous CD7 CAR-T expands later (>day 10), requiring pre-treatment debulking, whereas UCAR-T expands earlier (day 3–5), making it suitable for high tumor burden or rapid disease kinetics. CD7 CAR-T therapy is beneficial for PTCL with CD7 expression and shows strong efficacy in AML when followed by timely consolidation transplant.