Table 3. Fecal Microbiome Cohort: patient characteristics.
Fecal microbiome samples from patients at MSK and Penn who received anti-CD19 CAR T cell immunotherapy (N= 48) were prospectively collected. Patient characteristics are listed based on exposure to piperacillin-tazobactam, imipenem-cilastatin or meropenem (P-I-M) in the 30 days before CAR T cell infusion and evaluated for clinical characteristics and outcomes. Regarding the CAR costimulatory domain, all recipients of a 4-1BB product received tisagenlecleucel (n= 23). Recipients of a CD28 product either received an MSK investigational product (n= 2), axicabtagene ciloleucel (n= 21), or brexucabtagene autoleucel (n= 2). All tests were two-sided and there was no adjustment for multiple comparisons.
| Category | Total N= 48 (100%) | No P-I-M antibiotic exposure n= 43 (89.6%) | P-I-M antibiotic exposure n= 5 (10.4%) | p-value | |
|---|---|---|---|---|---|
| Institution | MSK | 28 (58.3) | 23 (53.5) | 5 (100.0) | 0.129 |
| Penn | 20 (41.7) | 20 (46.5) | 0 (0.0) | ||
| Age, median [IQR] | 64 [55-70] | 64 [55-70] | 70 [56-70] | 0.64 | |
| Gender | Female | 14 (29.2) | 13 (30.2) | 1 (20.0) | >0.999 |
| Male | 34 (70.8) | 30 (69.8) | 4 (80.0) | ||
| Disease | ALL | 2 (4.2) | 2 (4.7) | 0 (0.0) | >0.999 |
| NHL | 46 (95.8) | 41 (95.3) | 5 (100.0) | ||
| Prior Lines of Therapies - median [IQR] | 4 [3-5] | 4 [3-5] | 6 [5-6] | 0.111 | |
| Specific CD19 CAR T cell product | |||||
| 1928z | 2 (4.2) | 2 (4.7) | 0 (0.0) | 0.384 | |
| axicabtagene ciloleucel | 21 (43.8) | 17 (39.5) | 4 (80) | ||
| tisagenlecleucel | 23 (47.9) | 22 (51.2) | 1 (20.0) | ||
| brexucabtagene autoleucel | 2 (4.2) | 2 (4.7 | 0 (0.0) | ||
| Costimulatory Domain | 4-1BB | 23 (47.9) | 22 (51.2) | 1 (20.0) | 0.397 |
| CD28 | 25 (52.1) | 21 (48.8) | 4 (80.0) | ||
| Complete response, Day 100 | Yes | 23 (47.9) | 22 (51.2) | 1 (20.0) | 0.397 |
| No | 25 (52.1) | 21 (48.8) | 4 (80.0) | ||
| Toxicity | Yes | 33 (68.8) | 28 (65.1) | 5 (100.0) | 0.279 |
| No | 15 (31.2) | 15 (34.9) | 0 (0.0) | ||
| Cytokine release syndrome | Yes | 30 (62.5) | 26 (60.5) | 4 (80.0) | 0.714 |
| No | 18 (37.5) | 17 (39.5) | 1 (20.0) | ||
| CRS Grade | 0 | 18 (37.5) | 17 (39.5) | 1 (20.0) | 0.817 |
| 1 | 15 (31.2) | 13 (30.2) | 2 (40.0) | ||
| 2 | 14 (29.2) | 12 (27.9) | 2 (40.0) | ||
| 3 | 1 (2.1) | 1 (2.3) | 0 (0.0) | ||
| ICANS/ Neurotoxicity | Yes | 12 (25.0) | 8 (18.6) | 4 (80.0) | 0.014 |
| No | 36 (75.0) | 35 (81.4) | 1 (20.0) | ||
| ICANS Grade | 0 | 36 (75.0) | 35 (81.4) | 1 (20.0) | <0.001 |
| 1 | 6 (12.5) | 5 (11.6) | 1 (20.0) | ||
| 2 | 3 (6.2) | 0 (0.0) | 3 (60.0) | ||
| 3 | 3 (6.2) | 3 (7.0) | 0 (0.0) | ||
| Vital Status, last follow-up | Alive | 33 (68.8) | 32 (74.4) | 1 (20.0) | |
| Dead | 15 (31.2) | 11 (25.6) | 4 (80.0) |
Abbreviations: CR: complete response; ALL: acute lymphoblastic leukemia; NHL: non-Hodgkin lymphoma; CRS: cytokine release syndrome; ICANS: immune effector cell-associated neurotoxicity syndrome; No P-I-M antibiotic exposure: patients exposed to non-P-I-M plus patients who did not receive any antibiotics within the 4 weeks before CD19 CAR T cell infusion