Table 1 Patient baseline characteristics and clinical outcomes

From: C-JUN overexpressing CAR-T cells in acute myeloid leukemia: preclinical characterization and phase I trial

Pt (no.)

Prior Lines of Therapies (no.)

Prior SCT

Disease Status

Clinical Outcomes

Disease Burden

CD33 Expression (%, by FCM)

Infusion Dose (106/kg)

Safety

Efficacy

BM blasts (%, by morphology)

BM blasts (%, by FCM)

EMD

CRS

Neurotoxicity

DLT

Response at day 15

Response at day 30

Response within 3 months

1

2

NO

22.50

21.05

NO

99.79

0.5

1

0

0

PR

NR

MRD+ CRi

2

4

Allo-SCT

86.50

61.96

NO

99.93

0.5

4

1

1

MRD CRi

MRD CRi

MRD CRi

3

6

Allo-SCT

67.00

51.11

NO

98.80

0.5

2

0

0

MRD CRi

MRD CRi

MRD CRi

4

4

Allo-SCT

10.50

4.35

NO

99.30

0.5

2

1

0

MRD+ CRi

NR

NR

  1. AML acute myeloid leukemia, BM bone marrow, CRi complete remission with incomplete hematologic recovery, CRS cytokine release syndrome, DLT dose-limiting toxicity, EMD extramedullary disease, MRD minimal residual disease, NR no response, PR partial remission, Pt patient, SCT stem cell transplantation.
  2. Patient 1 received a second CAR T-cell infusion (3.76 × 106/kg) on day 29 after the first CAR T-cell infusion. During the second infusion, the patient developed grade 2 CRS and was assessed as MRD− CRi 15 days after the second infusion, and the patient subsequently received SCT and has maintained disease-free.