Baseline characteristics of all 18 patients at screening
| Characteristic . | Eligible patients (N = 18) . |
|---|---|
| Median age (range), y | 53.5 (38-66) |
| Sex (male/female) | 10/8 |
| Median time since diagnosis (range), mo* | 31.9 (8.8-94.3) |
| ECOG performance status score | |
| 0 | 3 |
| 1 | 15 |
| DS staging I/II/III | 0/1/17 |
| ISS staging I/II/III | 10/8/0 |
| High-risk cytogenetic features, n (%)† | 7 (38.9) |
| Bone marrow blast ≥50%, n (%) | |
| Aspiration | 2 (11.1) |
| Biopsy | 6 (33.3) |
| EMM and/or sPCL, n (%)‡ | 5 (27.8) |
| Median BCMA expression on plasma cells (range), % | 82.9 (57.5-99.5) |
| Median BCMA MFI on plasma cells (range)§ | 1393 (761-51 023) |
| Median sBCMA level (range), ng/mL | 101.99 (7.12-198.58) |
| Median prior lines of therapy (range) | 4 (3-6) |
| Prior drug refractoriness,ǁ n (%) | |
| Bortezomib | 18 (100) |
| Lenalidomide | 18 (100) |
| Ixazomib | 3 (16.7) |
| Daratumumab | 2 (11.1) |
| Carfilzomib | 2 (11.1) |
| Pomalidomide | 2 (11.1) |
| Auto-HSCT | 6 (33.3) |
| Murine BCMA CART trial | 4 (22.2) |
| Characteristic . | Eligible patients (N = 18) . |
|---|---|
| Median age (range), y | 53.5 (38-66) |
| Sex (male/female) | 10/8 |
| Median time since diagnosis (range), mo* | 31.9 (8.8-94.3) |
| ECOG performance status score | |
| 0 | 3 |
| 1 | 15 |
| DS staging I/II/III | 0/1/17 |
| ISS staging I/II/III | 10/8/0 |
| High-risk cytogenetic features, n (%)† | 7 (38.9) |
| Bone marrow blast ≥50%, n (%) | |
| Aspiration | 2 (11.1) |
| Biopsy | 6 (33.3) |
| EMM and/or sPCL, n (%)‡ | 5 (27.8) |
| Median BCMA expression on plasma cells (range), % | 82.9 (57.5-99.5) |
| Median BCMA MFI on plasma cells (range)§ | 1393 (761-51 023) |
| Median sBCMA level (range), ng/mL | 101.99 (7.12-198.58) |
| Median prior lines of therapy (range) | 4 (3-6) |
| Prior drug refractoriness,ǁ n (%) | |
| Bortezomib | 18 (100) |
| Lenalidomide | 18 (100) |
| Ixazomib | 3 (16.7) |
| Daratumumab | 2 (11.1) |
| Carfilzomib | 2 (11.1) |
| Pomalidomide | 2 (11.1) |
| Auto-HSCT | 6 (33.3) |
| Murine BCMA CART trial | 4 (22.2) |
Auto-HSCT, autologous hematopoietic stem cell transplantation; DS, Durie-Salmon; ECOG, Eastern Cooperative Oncology Group; ISS, International Staging System; MFI, mean fluorescence intensity; sPCL, secondary plasma cell leukemia.
Defined as the time spanning the initial diagnosis until screening in this study.
Cytogenetic features were evaluated by florescence in situ hybridization. The probes were Del(17p), 1q21, Del (13q), t(4;14), t(11;14), and t(14;16). High-risk cytogenetic features included the following abnormalities detected by conventional cytogenetics or fluorescence in situ hybridization: Del(17p), t(4;14), or t(14;16).
No patients had PCL at screening; only 1 patient developed sPCL during the time of CAR T-cell production.
MFI was not available for patient 01-023, a patient with EMM who had no involvement in the bone marrow.
Refractoriness to a drug (administered either alone or in combination with other agents) was defined as no response (less than partial response) or progression on therapy or within 60 days of stopping the drug-containing regimen.