Table 1.
Patient demographics and treatment history
| Patient ID | Age | Sex | Diagnosis | Prior Therapies | Disease Stage | Tumor Burden (SPD in cm2) | ALC at Screening (×10^3/μL) | Bridging Therapy | Dosing Level | CAR+ T Cells Received | CRS (Grade) | ICANS (Grade) | Best Response (PFS) | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| # of Lines | Therapies | Notes | |||||||||||||
| 001 | 60 | M | MCL | 4 | Bendamustine/rituximab | IV | 467.8 | 0.40 | Cyclophosphamide | DL1 | 53 × 10^6 | Yes (1) | No | CR (30+) | |
| Rituximab | |||||||||||||||
| Acalabrutinib | |||||||||||||||
| Umbralisib/ublituximab | |||||||||||||||
| 002 | 58 | M | FL | 4 | Bendamustine/rituximab | Primary Refractory | IV | 350 | 0.96 | Cyclophosphamide R-EPOCH | DL1 | 58 × 10^6 | Yes (1) | No | CR (24+) |
| R-CHOP | |||||||||||||||
| R-ICE | |||||||||||||||
| Lenalidomide/rituximab | |||||||||||||||
| 003 | 29 | F | DLBCL (PMBCL) | 2 | R-EPOCH | IV | 187 | 0.17 | R-GEMOX | DL1 | 52 × 10^6 | Yes (1) | No | PD | |
| R-ICE | |||||||||||||||
| 004 | 62 | M | FL | 4 | Bendamustine/rituximab | POD24; Refractory to CD19 BiTE | IV | 88.4 | 1.02 | R-GEMOX (did not tolerate/complete rituximab) | DL1 | 56 × 10^6 | Yes (1) | No | CR (18) |
| ROR1-Targeting Antibody-Drug Conjugate | |||||||||||||||
| Anti-CD19 BiTE | |||||||||||||||
| Rituximab/gemcitabine/oxaliplatin | |||||||||||||||
| 005 | 35 | F | FL | 3 | Bendamustine/rituximab | POD24 | IV | 150 | 1.12 | None | DL2 | 165 × 10^6 | Yes (1) | No | CR (18+) |
| Rituximab | |||||||||||||||
| Rituximab/dexamethasone | |||||||||||||||
| 009 | 67 | M | DLBCL (NOS) | 4 | Rituximab/cyclophosphamide/ etoposide | Primary Refractory | IV | 29.2 | 2.09 | GEMOX | DL2 | 158 × 10^6 | Yes (1) | No | CR (9+) * |
| R-CHOP | |||||||||||||||
| R-ICE | |||||||||||||||
| ASCT | |||||||||||||||
| 010 | 56 | M | DLBCL (tFL) | 3 | Bendamustine/rituximab | IV | 812 | 0.63 | ICE | DL1 | 42 × 10^6 | No | No | CR (12+) | |
| R-CHOP | |||||||||||||||
| R-ICE | |||||||||||||||
| 014 | 64 | M | DLBCL (tFL) | 2 | Rituximab/gemcitabine/dexamethasone/carboplatin | Primary Refractory | IV | 404.8 | 2.60 | ICE | DL2 | 146 × 10^6 | No | No | CR (9+) |
| R-CHOP | |||||||||||||||
| 016 | 70 | M | DLBCL (tFL) | 4 | R-CHOP | IV | 44 | 1.20 | GEMOX + R-GEMOX | DL1 | 37 × 10^6 | Yes (1) | No | PR (2) | |
| BP + polatuzumab | |||||||||||||||
| R-ICE | |||||||||||||||
| R-GEMOX | |||||||||||||||
| 017 | 39 | M | DLBCL (HGBCL double-hit) | 2 | R-CHOP | Primary Refractory | IV | 701.5 | 1.88 | ICE | DL1 | 36 × 10^6 | No | No | PR (2+) |
| R-EPOCH | |||||||||||||||
Patient 009 elected to transition to comfort care shortly prior to the scheduled 12-month follow-up. Biopsy performed at that time showed no evidence of lymphoma. However, CR at 12 month was not verified with PET scan.
Abbreviations: SPD: sum of the products of diameters; ALC: absolute lymphocyte count; CRS: cytokine release syndrome; ICANS: immune-effector cell associated neurotoxicity syndrome; PFS: progression-free survival; MCL, mantle-cell lymphoma; FL, follicular lymphoma; PMBCL, primary mediastinal B-cell lymphoma; DLBCL, diffuse large B-cell lymphoma; tFL, transformed follicular lymphoma; R-CHOP: rituximab/cyclophosphamide/doxorubicin/hydrochloride/vincristine sulfate/prednisone; R-ICE: rituximab/ifosfamide/carboplatin/etoposide; R-EPOCH: rituximab/etoposide/prednisone/vincristine/cyclophosphamide/doxorubicin; BR: bendamustine/rituximab; BiTE: bispecific T-cell engager; ASCT: autologous stem-cell transplant; R-GEMOX: Rituximab/gemcitabine/oxaliplatin; ICE: ifosfamide/carboplatin/etoposide; CR: complete response; PR: partial response; PD: progressive disease