Multivariable analyses of factors associated with outcomes and CAR T-cell in vivo expansion after CART2
| . | OR, HR, β . | 95% CI . | P . |
|---|---|---|---|
| Multivariable logistic regression for best response, OR | |||
| Pre-CART1 lymphodepletion | |||
| Non-Cy-Flu lymphodepletion | 1 | ||
| Cy-Flu lymphodepletion | 48.42 | 4.29-7018.31 | <.001 |
| CAR T-cell dose augmentation (CART2 > CART1 dose) | |||
| No | 1 | ||
| Yes | 6.38 | 1.07-58.08 | .04 |
| Disease type | |||
| ALL | 1 | ||
| CLL | 1.86 | 0.26-13.89 | .53 |
| NHL | 7.82 | 1.43-60.59 | .02 |
| Multivariable Cox regression for PFS after CART2, HR | |||
| Pre-CART1 lymphodepletion | |||
| Non-Cy-Flu lymphodepletion | 1 | ||
| Cy-Flu lymphodepletion | 0.16 | 0.06-0.41 | <.001 |
| CAR T-cell dose augmentation (CART2 > CART1 dose) | |||
| No | 1 | ||
| Yes | 0.29 | 0.11-0.72 | .008 |
| Disease type | |||
| ALL | 1 | ||
| CLL | 0.33 | 0.12-0.91 | .03 |
| NHL | 0.49 | 0.23-1.02 | .06 |
| Multivariable linear regression model for post-CART2 CD8+CAR T-cell peak in blood, β | |||
| Pre-CART1 lymphodepletion | |||
| Non-Cy-Flu lymphodepletion (reference category) | |||
| Cy-Flu lymphodepletion | 1.65 | 0.82-2.49 | <.001 |
| CAR T-cell dose augmentation (CART2 > CART1 dose) | |||
| No | |||
| Yes | 0.19 | −0.53 to 0.91 | .59 |
| Disease type | |||
| ALL (reference category) | |||
| CLL | 1.16 | 0.21-2.12 | .02 |
| NHL | 0.85 | 0.05-1.64 | .04 |
| CD19+ cell count in blood (100 cells/µL increment) | 0.03 | −0.001 to 0.06 | .06 |
| CART2 end-manufacturing product | |||
| Fresh | |||
| Cryopreserved* | −0.28 | −0.94 to 0.37 | .39 |
| Multivariable linear regression model for post-CART2 CD4+CAR T-cell peak in blood, β | |||
| Pre-CART1 lymphodepletion | |||
| Non-Cy-Flu lymphodepletion (reference category) | |||
| Cy-Flu lymphodepletion | 1.83 | 1.08-2.57 | <.001 |
| CAR T-cell dose augmentation (CART2 > CART1 dose) | |||
| No | |||
| Yes | 0.30 | −0.34 to 0.94 | .35 |
| Disease type | |||
| ALL (reference category) | |||
| CLL | 0.87 | 0.01-1.72 | .05 |
| NHL | 1.51 | 0.80-2.21 | <.001 |
| CD19+ cell count in blood (100 cells/µL increment) | 0.02 | −0.004 to 0.05 | .09 |
| CART2 end-manufacturing product | |||
| Fresh | |||
| Cryopreserved* | −0.28 | −0.87 to 0.30 | .33 |
| . | OR, HR, β . | 95% CI . | P . |
|---|---|---|---|
| Multivariable logistic regression for best response, OR | |||
| Pre-CART1 lymphodepletion | |||
| Non-Cy-Flu lymphodepletion | 1 | ||
| Cy-Flu lymphodepletion | 48.42 | 4.29-7018.31 | <.001 |
| CAR T-cell dose augmentation (CART2 > CART1 dose) | |||
| No | 1 | ||
| Yes | 6.38 | 1.07-58.08 | .04 |
| Disease type | |||
| ALL | 1 | ||
| CLL | 1.86 | 0.26-13.89 | .53 |
| NHL | 7.82 | 1.43-60.59 | .02 |
| Multivariable Cox regression for PFS after CART2, HR | |||
| Pre-CART1 lymphodepletion | |||
| Non-Cy-Flu lymphodepletion | 1 | ||
| Cy-Flu lymphodepletion | 0.16 | 0.06-0.41 | <.001 |
| CAR T-cell dose augmentation (CART2 > CART1 dose) | |||
| No | 1 | ||
| Yes | 0.29 | 0.11-0.72 | .008 |
| Disease type | |||
| ALL | 1 | ||
| CLL | 0.33 | 0.12-0.91 | .03 |
| NHL | 0.49 | 0.23-1.02 | .06 |
| Multivariable linear regression model for post-CART2 CD8+CAR T-cell peak in blood, β | |||
| Pre-CART1 lymphodepletion | |||
| Non-Cy-Flu lymphodepletion (reference category) | |||
| Cy-Flu lymphodepletion | 1.65 | 0.82-2.49 | <.001 |
| CAR T-cell dose augmentation (CART2 > CART1 dose) | |||
| No | |||
| Yes | 0.19 | −0.53 to 0.91 | .59 |
| Disease type | |||
| ALL (reference category) | |||
| CLL | 1.16 | 0.21-2.12 | .02 |
| NHL | 0.85 | 0.05-1.64 | .04 |
| CD19+ cell count in blood (100 cells/µL increment) | 0.03 | −0.001 to 0.06 | .06 |
| CART2 end-manufacturing product | |||
| Fresh | |||
| Cryopreserved* | −0.28 | −0.94 to 0.37 | .39 |
| Multivariable linear regression model for post-CART2 CD4+CAR T-cell peak in blood, β | |||
| Pre-CART1 lymphodepletion | |||
| Non-Cy-Flu lymphodepletion (reference category) | |||
| Cy-Flu lymphodepletion | 1.83 | 1.08-2.57 | <.001 |
| CAR T-cell dose augmentation (CART2 > CART1 dose) | |||
| No | |||
| Yes | 0.30 | −0.34 to 0.94 | .35 |
| Disease type | |||
| ALL (reference category) | |||
| CLL | 0.87 | 0.01-1.72 | .05 |
| NHL | 1.51 | 0.80-2.21 | <.001 |
| CD19+ cell count in blood (100 cells/µL increment) | 0.02 | −0.004 to 0.05 | .09 |
| CART2 end-manufacturing product | |||
| Fresh | |||
| Cryopreserved* | −0.28 | −0.87 to 0.30 | .33 |
Using logistic and Cox models, the following predictors were included for BMA: disease type, pre-CART1 and pre-CART2 lymphodepletion, response to CART1, LDH serum concentration before pre-CART2 lymphodepletion, CAR T-cell dose augmentation (CART2 dose > CART1 cell dose vs CART2 dose = CART1 cell dose), time from CART1 to CART2, fresh vs cryopreserved CART2 infusion product, CART2 manufacturing (4 categories: reformulation using cryopreserved CAR T cells previously stored at the end of CART1 manufacturing, stimulation and transduction of T cells previously or newly collected, re-stimulation of transduced T cells previously stored in process for CART1, or other), B cell recovery in the blood between CART1 and CART2. For the linear regression model, all predictors listed above were included for BMAm in addition to the CD19+ cell count in blood.
Cryopreserved only or mix of cryopreserved and fresh end-manufacturing CAR T cells.