-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.

2007 Allogeneic and Autologous Anti-CD7 CAR-T Cell Therapies in Relapsed or Refractory T Cell Malignancies

Program: Oral and Poster Abstracts
Session: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster I
Hematology Disease Topics & Pathways:
Lymphoid Leukemias, ALL, Biological therapies, Lymphomas, Chimeric Antigen Receptor (CAR)-T Cell Therapies, T Cell lymphoma, Diseases, Therapies, Lymphoid Malignancies
Saturday, December 10, 2022, 5:30 PM-7:30 PM

Yinqiang Zhang1,2*, Chenggong Li1,2*, Huiwen Jiang1,2*, Wenjing Luo1,2*, Mengyi Du1,2*, Fen Zhou1,3*, Lu Tang1,2*, Jianghua Wu1,2*, Qiuzhe Wei1,2*, Cong Lu1,2*, Haiming Kou1,2*, Di Wu4*, Chang Alex H5*, Heng Mei1,2* and Yu Hu1,2*

1Hubei Clinical Medical Center of Cell Therapy for Neoplastic Disease, Wuhan, China
2Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
3Department of Pediatrics, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
4Beijing GoBroad Hospital Management Co.,Ltd, Beijing, China
5Shanghai YaKe Biotechnology Ltd, Shanghai, China


To evaluate the safety and efficacy of anti-CD7 chimeric antigen receptor-T (CAR-T) therapies in teenagers and adult patients with relapsed/refractory (R/R) T cell malignancies, as well as differences between autologous and allogeneic CAR-T cells.


This Phase I, single-arm, open-label clinical trial (NCT04823091) enrolled patients with R/R T-Cell Acute Lymphoblastic Leukemia (T-ALL)/ Lymphoblastic Lymphoma (LBL) (aged 14-70 years). Patients underwent lymphodepletion with fludarabine and cyclophosphamide followed by CAR-T infusion at a dose of 1x106 or 2x106/kg on D0. CAR-T cells were manufactured either from patients or donors, based primarily on the patient’s tumor burden, pancytopenia status, donor availability and the wishes of the patient. Donors could be 5/10 HLA-identical siblings or 10/10 HLA-matched. Bridging therapies were allowed if disease progressed between infusion and the collection of peripheral blood mononuclear cells (PBMCs).


From June 2021 to July 2022, 10 patients aged 14 to 69 with T-ALL (N=3) and T-LBL (N=7) were treated with anti-CD7 CAR-T cells. Five patients received autologous CAR-T cells and five received allogeneic CAR-T cells. Seven patients experienced grade ≤2 cytokine release syndrome (CRS) and one developed grade 3 CRS. The median onset and duration of CRS was 10 days and 4 days, respectively. Immune effector cell-associated neurotoxicity syndrome was not observed. Grade 1-2 graft versus host disease(GVHD)occurred in two patients. Patient (PT) 4 who receive allogeneic CAR-T developed acute GVHD presenting as diarrhea and maculopapular rash. PT2 with previous allogeneic transplantation received autologous CAR-T cells and developed chronic GVHD characterized as skin desquamation and pigmentation. Nine infections occurred in 5 patients, of which 55.6% occurred within 1 month after infusion.

The overall response rate (ORR) was 80%. The complete response (CR) rate of bone marrow was 100% (7/7) and ORR of extramedullary infiltration was 40% (CR: n=1, PR: n=1). With a median follow-up of 5 months (3-14 months), PT5 with T-ALL maintained MRD-negative remission for 9 months and PT1 with mycosis fungoides achieved complete remission after low-dose local radiotherapy with no relapse to date (Figure 1).

The median time of CAR-T peak expansion was 14 days after infusion (7-23 days) and the median peak numbers of CAR-T proliferation measured by flow cytometry and qPCR were 4.09x107/L (1.14x106-8.64x108/L) and 7.95x104 copies/ug DNA (2.88x102 -1.75x105 copies/ug DNA), respectively. Based on the statistical analysis with a small sample size, the peak number was not significantly correlated with the patients’ cell sources, disease subtypes, tumor burden or dose of infused cells, but was associated with the best efficacy (P=0.02). During follow-up, 50% of patients (4/8) had a relatively high level of CAR-T detected by qPCR at month 2, among whom 3 received allogeneic CAR-T cells and 1 received autologous CAR-T cells (Figure 2).

Although there were no significant differences between autologous and allogeneic CAR-T cells in terms of peak expansion and clinical response at month 1, allogeneic CAR-T cells exhibited significant longer duration. Patients receiving allogeneic CAR-T have a lower recurrence rate (25% vs 100%). As for safety, the incidence of adverse events (autologous vs allogeneic, severe CRS: 20% vs 0%, GVHD: 20% vs 20%, infection in one month: 60% vs 20%) was not increased in the allogeneic CAR-T group in 1 month. However, longer duration of thrombocytopenia (median: 25 vs 18 days) and virus infections (40% vs 20%) were more common in allogeneic CAR-T group, which might lead to the death of PT9 due to cerebral hemorrhage or PT4 due to viral pneumonia.


These results indicate that anti-CD7 CAR-T is a promising option for teenager and adult patients with R/R T cell malignancies, but it is crucial to choose the source of CAR-T cells and the corresponding support treatment. Due to the higher relapse rate in patients receiving autologous CAR-T cells, we recommend consolidation therapy should be considered. For patients with allogeneic CAR-T cells, long-term monitoring and timely intervention for hemogram and infection may significantly improve patients’ outcomes. Larger sample size and longer follow-up are needed to confirm this conclusion.

Disclosures: No relevant conflicts of interest to declare.

*signifies non-member of ASH