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Table 2 Comparison of KarMMa (bb2121) and LEGEND-2 (LCAR-B38M) clinical studies

From: Safety and clinical efficacy of BCMA CAR-T-cell therapy in multiple myeloma

 

bb2121 / KarMMa [59]

LCAR-B38M / LEGEND-2 (Xi’an site) [49, 50]

Alternative product name

ide-cel

cilta-cel

Trial # (study phase)

NCT03361748 (phase II)

NCT03090659 (phase I)

n of patients

128 (54 at RD of 450 × 106)

57

Expansion method

aCD3 + aCD28

aCD3/CD28 + IL-2

Loading method

Lentiviral

Lentiviral

CAR-T structure

Murine scFv

Llama 2xVHH

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Lymphodepletion

CP/Flu

CP

CAR-T cell dosage(s)

150–300 to 450 × 106

32.3 × 106 (3.3 to 126.2 × 106)

Patient characteristics

  

 Age (range), y

61 (33–78)

54 (27–72)

 Median n PLT (range)

6 (3–16)

3 (1–9)

 High-risk featuresa

51%

37%

CRS

96.3%b

89.5%

 Gr. 1–2

90.7%

82.5%

 Gr. ≥ 3

5.6%

7.0%

 Median onset (range)

1d (1–10)

9d (1–19)

 Median duration (range)

7d (1–63)

9d (3–57)

 Tocilizumab use

67%

46%

Neurotoxicity

20.4%b

1.8%

ORR

82%b

88%

 MRD CR

28%

68%

 CR

11%

5%

 VGPR

26%

4%

 PR

17%

11%

Median PFS (95% CI)

12.1m (8.8–12.3)b

19.9m (9.6–31)

  1. aCD3 + aCD28 = anti-CD3 and anti-CD28 antibodies. aCD3/CD28 + IL-2 = anti-CD3 and anti-CD28-coated beads plus interleukin-2. cilta-cel = ciltacabtagene autoleucel. CP = cyclophosphamide. CP/Flu = cyclophosphamide plus fludarabine. CR = complete response. CRS = cytokine release syndrome. d = days. Gr. = grade. ide-cel = idecabtagene vicleucel. m = months. MRD = minimal residual disease. n = number. ORR = objective response rate. PFS = progression-free survival. PLT = prior lines of treatment. RD = recommended dose. scFv = single-chain variable fragment. (VG)PR = (very good) partial response. VHH = heavy-chain variable region. Trial # = study registration number in Clinicaltrials.gov (NCT#). y = years
  2. aHigh-risk defined as R-ISS stage 3 and/or high-risk genetics (del(17p), t(4;14), t(14;16))
  3. bData shown for the 450 × 106 dose cohort only