Table 1.

Clinical characteristics of patients

Patient characteristics	N = 6 (%)
Median age (range) years	34.5 (7–52)
Female sex	1 (16.7%)
ECOG performance status ≤ 2	6 (100%)
Disease
AML	5 (83.3%)
AML evolving from MDS	1 (16.7%)
Median percentage of CD38 positive blasts (%)	95% (92–99%)
Allo-HSCT donor
Unrelated donor (10/10)	2 (33.3%)
Haplo donor (5/10)	4 (66.7%)
Conditioning regimen
Modified BuCy	5 (83.3%)
Decitabine + TBI-Cy	1 (16.7%)
Median time to recurrence post-allo-HSCT (months)	7.5 (5–17)
Treatment for relapsed AML post-allo-HSCT
Withdrawal of immunosuppression	5 (83.3%)
Donor lymphocyte infusion	2 (33.3%)
Azacitidine + Venetoclax	2 (33.3%)
Lenalidomide	1 (16.7%)
Interferon-α	1 (16.7%)
Tumor reduction chemotherapy before CAR-T-38 infusion
Decitabine + HAAG	5 (83.3%)
Decitabine + EAAG	1 (16.7%)
Source of CAR-T-38
Autologous	4 (66.7%)
Donor	2 (33.3%)
Median CAR-T-38 dose (range)	8.05 (6.1–10) × 106/kg
Treatment response
1 week after CAR-T-38 infusion	2 CRi (33.3%)
2 weeks after CAR-T-38 infusion	4 CRi (66.7%)
4 weeks after CAR-T-38 infusion	4 (3 CR and 1 CRi) (66.7%)
6-month cumulative recurrence	2 (50%)
Adverse events
GvHD	0 (0.0%)
CRS grade 1–2	5 (83.3%)
CRS grade 3 (hematological toxicity)	1 (16.7%)
ICANS	0 (0.0%)
Neutropenia (< 500/μl)	6 (100.0%)
Thrombocytopenia (< 10,000/μl)	6 (100.0%)
Documented infection	1(16.7%)

ECOG: Eastern Cooperative Oncology Group; AML: Acute myeloid leukemia; MDS: Myelodysplastic syndrome; allo-HSCT: Allogeneic hematopoietic stem cell transplantation; Haplo donor: Haploidentical donor; BuCy: High-dose busulfan and cyclophosphamide; TBI: Total body irradiation. HAAG: Homoharringtonine (H), Cytarabine (A), Aclarubicin (A), Granulocyte colony stimulating factor (G); ECAG: Etoposide (E), Cytarabine (C), Aclarubicin (A), Granulocyte colony stimulating factor (G); CRS: Cytokine release syndrome; ICANS: Immune effector cell-associated neurotoxicity syndrome