Table 1 Baseline characteristics.

From: Long-term activity of tandem CD19/CD20 CAR therapy in refractory/relapsed B-cell lymphoma: a single-arm, phase 1–2 trial

Characteristics

No. of

patients % (infusion)

(n = 87)

No. of patients %

(leukapheresis)

(n = 92)

Age (years), no. (%)

 <60

71 (82%)

75 (82%)

 ≥60

16 (18%)

17 (18%)

Sex, no. (%)

 Male

41 (47%)

42 (46%)

 Female

46 (53%)

50 (54%)

ECOG performance status score, no. (%)

 0–1

54 (62%)

59 (64%)

 2

33 (38%)

33 (36%)

Disease stage at study entry

 I or II

13 (15%)

14 (15%)

 III or IV

74 (85%)

78 (85%)

Diagnosis by central histologic review, no. (%)

 DLBCL

58 (66%)

61 (66%)

 tFL

6 (7%)

7 (8%)

 FL

13 (15%)

13 (14%)

 PMBCL

5 (6%)

5 (5%)

 Others

5 (6%)

6 (7%)

IHC

 CD20+

87 (100%)

92 (100%)

 CD19+

78 (89%)

83 (90%)

 CD19

4 (5%)

4 (4%)

 CD19 missing data

5 (6%)

5 (5%)

 Double or triple protein expression: MYC plus BCL2, BCL6 or both, no. (%)

 Yes

30 (34%)

33 (36%)

 No

38 (44%)

40 (43%)

 Missing data

19 (22%)

19 (21%)

 Ki-67 (≥70%)

54 (62%)

57 (62%)

Extranodal organ involvement, no. (%)

 Yes

62 (71%)

65 (71%)

 No

25 (29%)

27 (29%)

No. of previous lines of antineoplastic therapy, no. (%)

 ≤2

23 (27%)

24 (26%)

 3–5

49 (56%)

52 (57%)

 ≥6

15 (17%)

16 (17%)

Refractory or relapse, no. (%)

 Refractory

70 (80%)

74 (80%)

 Relapse to second-line or later therapy

17 (20%)

18 (20%)

 Relapse after ASCT

12 (14%)

12 (13%)

 Relapse after previous CD19 CAR T cell therapy

9 (10%)

9 (10%)

Tumour burden

 SPD ≥ 100 cm2

24 (28%)

27 (29%)

 SPD < 100 cm2

63 (72%)

65 (71%)

Bulky/non-bulky disease

 Lesion diameter ≥ 10 cm

19 (22%)

21 (23%)

 Lesion diameter < 10 cm

68 (78%)

71 (77%)

  1. Advanced stage disease was defined as stage III or IV according to the modified Ann Arbor staging system with higher stage numbers indicating greater dissemination of cancer through the body [40].
  2. ECOG performance status values range from 0 to 5 with higher scores indicating increasing disability.
  3. The sum of the product of the diameters (SPD) was calculated as the sum of the long axis and short axis of all measurable sites.
  4. Relapse to ASCT
  5. • Disease progression or relapse ≤12 months after ASCT (biopsy-proven recurrence required for relapsed subjects).
  6. Relapse after previous CD19 CAR T cell therapy
  7. • Disease progression or relapse ≤6 months after previous CD19 CAR T cell therapy (biopsy-proven recurrence required for relapsed subjects).
  8. ASCT autologous stem cell transplantation, CAR chimeric antigen receptor, DLBCL diffuse large B-cell lymphoma, ECOG Eastern Cooperative Oncology Group, FL follicular lymphoma, IHC immunohistochemistry, PMBCL primary mediastinal B-cell lymphoma, SPD sum of the product of the diameters, tFL transformed follicular lymphoma.