On August 22–23, 2025, the 13th Lu Daopei Hematology Conference was held in Beijing, jointly organized by the Beijing Health Promotion Association and the Guangzhou Kapok Oncology and Rare Disease Foundation, and hosted by the Beijing Lu Daopei Hematology Institute. The conference gathered world-leading experts and focused on hematopoietic stem cell transplantation, cellular therapy, and precision treatment of hematologic malignancies. With over a thousand participants, the meeting provided a high-level and in-depth academic exchange. During the conference, Professor Peihua Lu, President of the Lu Daopei Hematology Institute and Lu Daopei Hospital, delivered a keynote presentation on “CD7 CAR-T Therapy in Hematologic Malignancies: Opportunities and Challenges.” Oncology Frontier – Hematology News invited Professor Lu to further analyze the key highlights of the conference and to provide in-depth insights into this emerging field, offering valuable guidance for clinical management strategies in T-cell malignancies.________________________________________
PART 1
In clinical studies and practice, particularly those pioneered by the Lu Daopei team, what efficacy potential and limitations has CD7 CAR-T shown in relapsed/refractory (r/r) T-cell malignancies? Where do you see its role in the current treatment landscape, and in which patient groups does it demonstrate the most breakthrough value?
Professor Peihua Lu: In recent years, both domestic and international studies have made progress in applying CD7 CAR-T therapy to T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL). CD7 is expressed in most T-ALL/LBL cases, but it is also expressed on normal T lymphocytes, which results in a “fratricide” effect that undermines CD7 CAR-T efficacy.
Our team developed a novel strategy to prevent fratricide by using lentiviral transduction of peripheral T cells to generate naturally selected anti-CD7 CAR-T cells (NS7CAR). These NS7CAR cells overcome CD7-directed fratricide without requiring additional genetic modifications. Although NS7CAR-T cells still retain CD7 expression, the CD7 molecules on their surface are masked by the CAR or sequestered intracellularly, thereby minimizing available surface CD7 antigen and effectively avoiding self-killing.
In our Phase I/II clinical study of NS7CAR-T for T-ALL/LBL, 60 patients received NS7CAR-T infusions. Following treatment, 94.4% of patients achieved deep complete remission (CR) in the bone marrow. Among 32 patients with extramedullary disease (EMD), the overall response rate (ORR) reached 78%, with 56% achieving CR and 22% partial remission (PR). The two-year overall survival (OS) and progression-free survival (PFS) rates were 63.5% and 53.7%, respectively.
However, autologous CD7 CAR-T still has limitations. Some T-cell malignancies progress very rapidly, while autologous NS7CAR-T manufacturing requires several weeks. To address this challenge, we explored the use of allogeneic or universal CAR-T therapy in r/r T-ALL/LBL.
Universal CAR-T therapy offers several advantages. First, once manufactured, universal CAR-T can be used for multiple patients without delay, ensuring timely treatment. Second, many T-ALL patients have high circulating tumor burden, which prevents the use of their own T cells to manufacture autologous CAR-T. In such cases, universal CAR-T provides a feasible alternative. Third, universal CAR-T is more cost-effective and accessible compared with most autologous products.
Our multicenter clinical trial demonstrated that among patients with high tumor burden in the bone marrow, the MRD-negative CR rate reached 81%. Even in patients with extramedullary disease—a more challenging scenario—over 50% achieved CR. Furthermore, about 58% of patients proceeded to allo-HSCT after CAR-T therapy, with one-year OS and leukemia-free survival rates as high as 80.7%.
Overall, universal CD7 CAR-T offers a new and promising therapeutic option for r/r T-ALL/LBL patients.
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PART 2
You also mentioned the potential of CD7 CAR-T in r/r acute myeloid leukemia (AML). What are the main challenges recognized in this field, and what innovative strategies has the Lu Daopei team developed to overcome them? What preliminary progress has been made?
Professor Peihua Lu: Prognosis remains poor for patients with r/r AML, even for those who undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT), highlighting the urgent need for novel therapies. Researchers worldwide have investigated various targets for AML, but results so far have been disappointing. About 30% of AML patients express CD7 on their leukemic blasts, which prompted our center to initiate a Phase I clinical trial to evaluate CD7 CAR-T therapy in r/r AML. Results of this trial were published last year in Blood.
Building on the encouraging efficacy and safety of NS7CAR-T in T-ALL/LBL, we further advanced to develop a nanobody-based NS7CAR-T. This dVHH NS7CAR incorporates two anti-CD7 nanobody (VHH) coding regions. With a molecular size of only 15 kDa—about one-tenth the size of human IgG—nanobodies retain strong affinity and specificity using just three complementarity-determining regions (CDRs). Their high similarity to human VH gene family III also confers lower immunogenicity compared with murine monoclonal antibodies. Nanobody-based CAR-T cells demonstrated enhanced effector cytokine release.
To establish the landscape of CD7 expression in AML, our center screened 1,253 r/r AML patients over 18 months. Results showed that 32% had ≥20% CD7 expression on blasts, 22% had ≥50%, and 17% had ≥80%. This dataset is the most comprehensive to date on CD7 expression in AML and provides a strong foundation for future clinical trials.
In the Phase I trial, 10 AML patients received dVHH NS7CAR-T infusions. At day 28, 7 of 10 (70%) achieved complete remission (CR) in the bone marrow, with 6 reaching MRD-negative CR. Three patients had no response (NR); among them, one patient with EMD achieved PR by day 35 on PET-CT evaluation. All non-responders showed CD7 antigen loss. Importantly, the nanobody-based NS7CAR-T demonstrated manageable safety and encouraging efficacy in CD7-positive AML patients, including those heavily pretreated. Bridging to allo-HSCT after NS7CAR-T remains critical to achieving durable remission.
It is worth noting that antigen loss appears to be more common in AML patients treated with CAR-T. Larger cohorts and longer follow-up will be necessary to fully evaluate this approach.
PART 3
This year marks the 13th Lu Daopei Hematology Conference, one of the most highly regarded meetings in the field. What are your expectations for this year’s conference, and what recent advances or breakthrough studies should clinicians and researchers pay particular attention to?
Professor Peihua Lu: The Lu Daopei Hematology Conference has been successfully held for twelve consecutive years, and this year marks its 13th edition, which we have all been eagerly anticipating. Our mission has always been to deepen academic exchange in China’s hematology field and to drive clinical innovation. This year’s conference focuses on a wide range of cutting-edge areas, including hematopoietic stem cell transplantation, CAR-T cell immunotherapy, the diagnosis and treatment of lymphoma and multiple myeloma, diagnostic laboratory advances, post-transplant infection control, standardized management of comorbidities, and patient care. We invited leading experts from China and abroad to share the latest research findings and clinical experience.
The conference has become a high-level academic platform connecting research and clinical practice, as well as domestic and international expertise. It has effectively promoted multidisciplinary collaboration and advanced the standardization, personalization, and precision of hematologic disease management.
There are several key highlights this year. In CAR-T cell therapy, particularly in CD7 CAR-T for T-cell malignancies, we have seen encouraging clinical data that bring new hope to relapsed and refractory patients. In hematopoietic stem cell transplantation, we discussed innovations in transplantation for elderly patients, cord blood transplantation, and the management of post-transplant complications. In lymphoma and myeloma, several domestic multicenter studies and real-world data were presented, providing valuable references for clinical decision-making. Diagnostic techniques have also advanced significantly, with improvements in flow cytometry and molecular genetic testing enhancing both early diagnosis and treatment response assessment.
The meeting also featured renowned international experts. Among them were Professor Robert Negrin, current President of the American Society of Hematology (ASH) and my former mentor during my fellowship at Stanford Medical Center, and Professor Ibrahim Yakoub-agha, incoming President of the European Society for Blood and Marrow Transplantation (EBMT). Both delivered outstanding lectures.
In addition, the conference emphasized interdisciplinary collaboration. For example, Professor Xiangyan Ruan from Beijing Obstetrics and Gynecology Hospital, Capital Medical University, a pioneer in ovarian transplantation in China, presented on the potential value of ovarian transplantation for improving long-term quality of life in cancer patients. Other sessions explored how nutritional support and advances in imaging research can be more effectively integrated into clinical practice.
Each year, the Lu Daopei Hematology Conference stands out with its academic highlights, attracting clinicians and research teams to engage in in-depth discussion and exchange of ideas, and it has consistently received high recognition and positive feedback from the academic community. I believe these cutting-edge developments will not only provide stronger evidence to guide clinical decision-making but will also inspire new directions for future research.
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Expert Profile
Professor Peihua Lu
Executive Medical Director, Lu Daopei Hospital
President, Beijing Lu Daopei Hematology Institute
Professor Lu graduated from Peking University Health Science Center, completed her residency at the University of Nebraska Medical Center, and went on to specialize in hematology and oncology at Stanford University, where she obtained subspecialty certification. She is board-certified in hematology and oncology in both the United States and China.
She serves as a member of the 4th Academic Committee of the Department of Oncology, Capital Medical University; Standing Director of the 1st Council of the China Non-Public Medical Institutions Association; Chair of the Hematology Committee and Standing Member of the Biotechnology and Cell Application Committee of the China Non-Public Medical Institutions Association; Member of the Expert Committee of the China Marrow Donor Program; Standing Member of the Anti-Leukemia Alliance Expert Committee of the Chinese Society of Clinical Oncology (CSCO); Standing Member of the Hematology Translational Medicine Committee of the Chinese Anti-Cancer Association; and Council Member of the 7th Board of the Beijing Medical Education Association.
In 2021, she received the Taishan Award for Medical Value in recognition of her outstanding leadership in medical management.
