Table 2.
T-cell-redirecting BiAb/BiTE vs CAR-T cell therapy in MM.
| BiAb/BiTE | CAR-T | |
|---|---|---|
| Structure | BiAb: Engineered artificial antibodies to recognize two epitopes of an antigen or two antigens. BiTE: A recombinant protein composed of two linked scFvs, with one targeting CD3 and the other one targeting MM antigen. |
A synthetic receptor composed of a target antigen-binding domain (scFv), a hinge region, a transmembrane domain, and intracellular signaling domains. |
| Immune synapse | Typical | Atypical |
| Effector cells | CD4 and CD8 cells | CD4 and CD8 cells |
| Availability | Off the shelf | 1. Maybe > 2 weeks for manufacture. 2. Rapid manufacturing process is under development. |
| Manufacturing failure | Not applicable | Around 10% |
| Administration | 1. No conditioning treatment. 2. Pretreatment: steroid. 3. Repeat dosing. |
1. Conditioning treatment (+). 2. Pretreatment: anti-histamine, acetaminophen. 3. One-time infusion. |
| The treatment response rate in RRMM | 1. Generally lower. 2. It may be similar to CAR-T therapy in patients treated with top doses or at the RP2D. |
Generally higher |
| Target antigen loss | Lower risk | Higher risk |
| CRS risk (≥ Gr 3) | 1. Generally lower. 2. Increase with a higher dose. |
Generally higher. |
| Neurotoxicity (≥ Gr 3) | Lower | Higher |
| Financial burden | Expensive | Expensive |
| FDA approval | Talquetamab (2022). | Idecabtagene vicleucel (2021) Ciltacabtagene autoleucel (2022). |
| EMA approval | Teclistamab (2022). | Idecabtagene vicleucel (2021). |
Gr, grade; scFV, single-chain fragment variable