Table 1 Patient baseline characteristics and PP CAR-T cell treatment outcomes.

From: Clinical outcomes of a new local CD19 CAR-T cell therapy for patients with relapsed or refractory acute lymphoblastic leukemia and non-Hodgkin lymphoma in Malaysia

Parameters

B-ALL

B-NHL

Total patients

n (%)

n (%)

n (%)

Subjects evaluable for safety, efficacy

8.8

22.21

30.29

Median age (range)

29 years (15–50)

56 years (26–72)

47.5 years (15–72)

Male

3 (37.5)

14 (63.6)

17 (56.7)

ECOG at study entry

0-1: 8 (100)

0–1: 19 (86.4)

2–3: 3 (13.6)

0–1: 27 (90.0)

2–3: 3 (10.0)

Tumor subtype

Pre B -ALL

Ph-positive: 2 (25.0)

DLBCL:14 (63.6)

PBMCL: 5 (22.7)

FL: 1 (4.55)

MCL: 1 (4.55)

High grade: 1 (4.55)

Double expressor: 1 (4.55)

Triple expressor: 4 (18.2)

 

Tumor cell of Origin

NR

GCB: 3 (13.6)

ABC: 4 (18.2)

 

Tumor stage

NR

Stage 2: 6 (27.3)

Stage 3: 6 (27.3)

Stage 4: 10 (45.5)

 

Serum LDH (>200 U/L)

NR

11 (50.0)

 

EM, EN and BM involvement

EM: 0

EN: 11 (50.0)

BM: 3 (13.6)

 

Bulky disease (more than 10 cm)

NR

2 (9.1%)

 

Prior Lines of treatment (median, range) (number of patients, %)

3 (2–3)

1–2:2 (25.0%)

3–4: 6 (75.0%)

2.5 (1–4)

1-2: 11 (50.0%)

3–4: 11(50.0%)

3 (1–4)

1–2: 13 (43.3%)

3–4: 17 (56.7%)

History of primary refractory disease

3 (37.5%)

Primary refractory 11 (50.0)

Relapse 11 (50.0)

 

Disease status at enrollment

>5% blast in BM

7 (87.5)

PR 1 (7.1)

PD 12 (85.7)

SD 1 (7.1)

 

Prior HSCT

 Allogeneic

4 (50.0)

0

4 (13.3)

 Autologous

1 (12.5)

6 (27.3)

7 (23.3)

Bridging therapy

5 (62.5)

16 (72.7)

21 (70)

CAR-T cell dose × 106/kg,

% viability (median, range)

2 (1.2–2.50),

84.8 (70.0–93.6)

2 (1.0–2.85),

85.5 (73.5–94.8)

2 (1.0–2.85),

85.5 (70.0–94.8)

Median follow-up (median, range)

16.8 (7.5–42.5 months)

12 (0.5–34 months)

12.5 (0.5–42.5 months)

CRS:

All grades,

6 (75.0)

8 (36.4)

14 (46.7)

Grade ≥ 3

0

1 (4.5)

1 (3.3)

ICANS:

All grades,

None

None

1 (3.3)

Grade ≥ 3

 

1 (4.5)

1 (3.3)

Cytopenia Grade ≥3

8 (100)

19 (86.4)

27 (90.0)

Febrile neutropenia

3 (37.5)

4 (18.2)

7 (23.3)

COVID infection

2 (25.0)

1 (7.1)

3 (10.0)

Infection (non COVID)

Grade 3

1 (12.5)

4 (18.2)

 

Grade 4

1 (12.5)

1 (4.5)

 

B cell aplasia and serum IgG

8 (100)

18 (81.8)

26 (86.7)

level below 400 mg/dL

4 (40)

6 (27.3)

10 (33.3)

Immunoglobulin replacement therapy

None

7 (33.3)

 

Best overall outcome

CR

8 (100)

MRD negative CR = 7 (87.5)

14 of 21 (66.7)

 

PR

NA

5 of 21 (23.8)

 

SD

NA

1 of 21 (4.8)

 

PD

NA

1 of 21 (4.8)

 

Ongoing response

4 (50.0) at med follow-up 16.8 months

12 of 21 (57.1) at med follow-up 12 months

 

CR

4 (50.0)

11 of 21(52.4) 11 of 19

 

PR

NA

1 of 21 (4.8)

 

DoR, (median, IQR)

35 (13.6,56.3)

Not reached

 

Median OS

Not reached

Not reached

 
  1. Data are expressed as n (%) unless otherwise indicated.
  2. Minimal residual disease (MRD) negativity is the absence of detectable leukemic cells with immunophenotypic aberrancies at a sensitivity of 10−4 or an undetectable bcr-abl transcript [6].
  3. ABC activated B cell-like type, B-ALL B acute lymphoblastic leukemia, B-NHL B-cell non-Hodgkin lymphoma, ECOG Eastern Cooperative Oncology Group performance status, DLBCL diffuse large B-cell lymphoma, PBMCL primary mediastinal large B-cell lymphoma, FL follicular Lymphoma, NR not relevant, LDH lactate dehydrogenase, EM extramedullary, EN extranodal, BM bone marrow, HSCT hematopoietic stem cell transplantation, CRS cytokine release syndrome, ICANS immune effector cell-associated neurotoxicity syndrome, OR overall response rate, CR complete response rate, GCB germinal center B cell-like type, MRD minimal residual disease, DoR duration of response, OS overall survival, PD progressive disease, NA not applicable.
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