-Author name in bold denotes the presenting author
-Asterisk * with author name denotes a Non-ASH member
Clinically Relevant Abstract denotes an abstract that is clinically relevant.

PhD Trainee denotes that this is a recommended PHD Trainee Session.

Ticketed Session denotes that this is a ticketed session.

891 Dasatinib and CAR-T Cell Therapy for Newly Diagnosed Ph-Positive Acute Lymphoblastic Leukemia in Adults

Program: Oral and Poster Abstracts
Type: Oral
Session: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Improving CAR-T Therapies for B Cell Malignancies
Hematology Disease Topics & Pathways:
Research, clinical trials, Lymphoid Leukemias, ALL, Biological therapies, adult, Clinical Research, Chimeric Antigen Receptor (CAR)-T Cell Therapies, Diseases, Therapies, Lymphoid Malignancies, Study Population, Human
Monday, December 11, 2023: 3:15 PM

Mingming Zhang1,2,3,4*, Yongxian Hu1,2,3,4*, Guoqing Wei2,3,4,5*, Shan Fu1*, Jingjing Feng1*, Ruimin Hong1*, Alex H. Chang6* and He Huang2,3,4,5*

1Bone Marrow Transplantation Center, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
2Institute of Hematology, Zhejiang University, Hangzhou, China
3Zhejiang Province Engineering Laboratory for Stem Cell and Immunity Therapy, Hangzhou, China
4Liangzhu Laboratory, Zhejiang University Medical Center, Hangzhou, China
5Bone Marrow Transplantation Center, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
6Shanghai YaKe Biotechnology Ltd, Shanghai, China


The use of tyrosine kinase inhibitors has improved outcomes of Ph-positive Acute lymphoblastic leukemia (ALL), but combinations with other agents are needed to achieve molecular response. CAR-T cell therapy has made a breakthrough in refractory or relapsed ALL, but has not yet been applied in newly diagnosed patients.


We conducted a phase 2 single-group trial of first-line therapy in adults with newly diagnosed Ph-positive ALL. Dasatinib in combination with a two-week vincristine and glucocorticoids regimen were administered, followed by sequential infusions of CD19 and CD22 CAR-T cells. All patients received single-agent dasatinib maintenance after CAR-T cell therapy. The primary endpoint was complete molecular response (defined as undetectable BCR/ABL1 transcript with a sensitivity of 0.001%) in the bone marrow after this treatment. Here we report initial results from this study.


At the cut-off date of 31 May 2023, 18 patients have received CD19 CAR-T cell infusions, and 14 of these patients have received subsequent CD22 CAR-T cell infusions. At the end of induction therapy, the complete hematologic remission rate was 100%, and 27.8% (5/18) of the patients had a complete molecular response. The percentage of complete molecular response increased to 72.2% (13/18) after CD19 CAR-T cell therapy, and increased further to 76.9% (10/13) after CD22 CAR-T cell therapy (1 patient has not been evaluated). Notably, of the 5 patients who did not achieve complete molecular response after CD19 CAR-T cell therapy, 4 have received CD22 CAR-T cell therapy, of which 1 eventually achieved complete molecular response and 2 experienced relapses. One patient had a CD19+ CD22+ relapse accompanied by mutations in BCR/ABL1 (F317L and Y253H) and the other patient had a CD19dim CD22+ relapse. After a median follow-up of 13.5 months, 16 patients remained in complete hematologic remission, and 14 patients remained in sustained complete molecular response. No patient received allogeneic stem cell transplantation. No grade 3 or higher cytokine release syndrome or Immune effector cell-associated neurotoxicity syndrome was observed during CAR-T cell therapies.


Dasatinib in combination with CAR-T cell therapy has enabled chemotherapy-free treatment in newly diagnosed Ph-positive ALL. This treatment is characterized by high complete molecular response, high long-term survival, low toxicity and short treatment cycles.

Disclosures: No relevant conflicts of interest to declare.

*signifies non-member of ASH