TABLE 1.
Characteristics of included studies.
| No | Study | Year | Registration number | Production name | Design | No. of patient | Conditioning | CAR-T infused dose | Antigen-recognition domain | Costimulatory molecule | Loading | Distinctive features | T cell origin | Follow up |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | Lin Y | 2020 | NCT02658929 | Idecabtagene Vicleucel (bb2121) | 2-part, phase 1, dose escalation and expansion | 62 | CP300 mg/m2 + Flu30 mg/m2 daily for 2d | 50 × 10^6cells (3) | A murine anti-BCMA ScFv | 4-1BB | __ | __ | __ | 14.7month |
| 150 × 10^6cells (18) | ||||||||||||||
| 450× 106^6cells (38) | ||||||||||||||
| 800 × 10^6cells (3) | ||||||||||||||
| 2 | Jennifer N. Brudno | 2018 | NCT02215967 | Anti-BCMA CAR-T cells | Phase I, single arm | 16 | CP300 mg/m2 +Flu30 mg/m2 daily for 3d | 9 × 10^6 cells/kg | A murine anti-BCMA ScFv | CD28 | Retrovirus | __ | __ | __ |
| 3 | Hao S | 2020 | NCT03716856, NCT03302403, NCT03380039 | Zevorcabtagene autoleucel (CT053) | 3-Site, phase I, single-arm, open-label | 24 | CP1610 mg + Flu108 mg daily for 2-4d | 150 × 10^6cells (21) | A fully human anti-BCMA ScFv (25C2) | 4-1BB | __ | __ | Autologous | 24 month. |
| 50 × 10^6cells (1) | ||||||||||||||
| 100 × 10^6cells (1) | ||||||||||||||
| 180 × 10^6cells (1) | ||||||||||||||
| 4 | Alsina M | 2020 | NCT03274219 | bb21217 | Multi-center, phase 1, dose escalation and expansion | 46 | CP300 mg/m2 + Flu30 mg/m2 daily for 3d | 150 × 10^6cells (12) | A murine anti-BCMA ScFv | 4-1BB | __ | the PI3K inhibitor bb007 | __ | 8.5 month |
| 300 × 10^6cells (14) | ||||||||||||||
| 450 × 10^6cells (20) | ||||||||||||||
| 5 | Wan-Hong Zhao | 2022 | NCT03090659 ChiCTR-ONH-17012285 | Ciltacabtagene autoleucel (JNJ-68284528 LCAR-B38M) | Multicenter, phase 1, single-arm, open-label | 74 | CP300 mg/m2 or CP250 mg/m2 + Flu20 mg/m2 | 0.513 × 10^6 cells/kg | Two llama-derived heavy-chain-based anti-BCMA single-domain antibodies | 4-1BB | Lentiviral | __ | Autologous | 47.8 month |
| 6 | Sham Mailankody | 2018a | NCT03430011 | Orvacabtagene autoleucel (JCARH125) | Multisite phase1/2, single arm | 8 | CP300 mg/m2 + Flu30 mg/m2 daily for 3d | 50 × 10^6 cells (5) | A fully human anti-BCMA ScFv | 4-1BB | Lentiviral | __ | __ | 5 weeks |
| 150 × 10^6 cells (3) | ||||||||||||||
| 7 | Kumar SK | 2020 | NCT03915184 | Zevorcabtagene autoleucel (CT053) | Multisite, Phase 1b/2, single arm | 14 | CP500 mg/m2/d*2d + Flu25 mg/m2/d*3d | 150–180 × 10^6cells (8) | A fully human anti-BCMA ScFv (25C2) | 4-1BB | __ | __ | Autologous | 4.5 month |
| 250–300× 10^6cells (6) | ||||||||||||||
| 8 | Sham Mailankody | 2018b | NCT03070327 | EGFRt/BCMA-41BBz CAR T cells (MCARH171) | Phase I, single arm | 11 | Cy3mg/m2 or CP/Flu: CP300 mg/m2 + Flu30 mg/m2 daily for 3d | 72–137×10^6 cells (6) | A human anti-BCMA ScFv | 4-1BB | __ | a truncated epidermal growth factor receptor safety system | Autologous | __ |
| 475–818×10^6 cells (5) | ||||||||||||||
| 9 | Di Wang | 2021 | ChiCTR1800018137 | CT103A | Phase 1, open-label, single-arm, dose escalation, and expansion | 18 | CP20 mg/m2 + Flu25 mg/m2 for 3d | 1 × 10^6 cells/kg (9) | A fully human anti-BCMA ScFv | 4-1BB | __ | __ | Autologous | 394 days |
| 3 × 10^6 cells/kg (6) | ||||||||||||||
| 6 × 10^6 cells/kg (3) | ||||||||||||||
| 10 | Shwetha H. Manjunath | 2021 | NCT02546167 | CART-BCMA | Phase I, single arm | 25 | CP or none | 10–50 × 10^6 cells (8) | A fully human anti-BCMA ScFv | 4-1BB | __ | __ | Autologous | 16.3 month |
| 100–500×10^6cells (17) | ||||||||||||||
| 11 | Damian J. Green | 2018 | NCT03338972 | Anti-BCMA CAR-expressing CD4+/CD8+ T-lymphocytes (FCARH143) | Phase I, single arm | 7 | Null | 50 × 10^6 cells (5) | A fully human anti-BCMA ScFv | 4-1BB | Lentiviral | The CD8+ and CD4+ T cells were stimulated with anti-CD3/antiCD28 paramagnetic beads | Autologous | __ |
| 150 × 10^6 cells (2) | ||||||||||||||
| 12 | Jesus G Berdeja MD | 2021 | NCT03548207 | Ciltacabtagene autoleucel (JNJ-68284528 LCAR-B38M) | Phase 1b/2 | 97 | CP300 mg/m2 + Flu30 mg/m2 daily for 3d | 0.75 × 10^6cells/kg | Two llama-derived heavy-chain-based anti-BCMA single-domain antibodies | 4-1BB | __ | __ | __ | 8.8 month |
| 13 | Nikhil C. Munshi | 2022 | NCT03361748 | Idecabtagene Vicleucel (bb2121) | Multicenter, phase 2, single-arm, open-label | 128 | CP300 mg/m2+Flu30 mg/m2 daily for 3d | 150 × 10^6 cells (4) | A murine anti-BCMA ScFv | 4-1BB | Lentiviral | __ | __ | 13.3 month |
| 300 × 10^6 cells (70) | ||||||||||||||
| 450 × 10^6 cells (54) | ||||||||||||||
| 14 | Xiaoyuan, Zhang | 2022 | __ | BCMA-CART cells | Phase I, single arm | 21 | CP1g/m2 for 5d + Flu20-25 mg/m2 daily for 3d | 4.2 × 10^6 cells/kg | A fully human anti-BCMA ScFv (14) | 4-1BB (14)4-1BB/CD28 (7) | __ | __ | Autologous | 19.3 month |
| A murine anti-BCMA ScFv (7) | ||||||||||||||
| 15 | Juan Du | 2022 | NCT03093168 | HDS269B | Open-label, single-arm, phase I/II | 49 | CP300 mg/m2 +Flu30 mg/m2 daily for 3d | 9 × 10^6 cells/kg | A murine anti-BCMA ScFv | 4-1BB/CD137 | Retrovirus | __ | Autologous | 14 month |
| 16 | Xiaoyan Qu | 2022 | NCT04322292 NCT03815383 NCT03751293 NCT04295018 | C-CAR088 | Multi-center, single-arm, open-label, phase 1, dose escalation and expansion | 31 | CP300 mg/m2 + Flu30 mg/m2 daily for 3d | 1 × 10^6 cells/kg (4) | A human IgG1 antibody anti-BCMA ScFv | 4-1BB | Lentiviral | __ | Autologous | 9.5 month |
| 3 × 10^6 cells/kg (13) | ||||||||||||||
| 6 × 10^6 cells/kg (14) | ||||||||||||||
| 17 | Chen W | 2020 | NCT03975907 | Zevorcabtagene autoleucel (CT053) | Phase 1, dose escalation and expansion | 14 | CP300 mg/m2 +Flu25 mg/m2 daily for 3d | 100 × 10^6cells (3) | A fully human anti-BCMA ScFv (25C2) | 4-1BB | __ | __ | Autologous | 5 month |
| 150 × 10^6cells (11) | ||||||||||||||
| 18 | Costello CL | 2020 | NCT03288493 | P-BCMA-101 | Phase 1/2 | 43 | CP300 mg/m2 + Flu30 mg/m2 daily for 3d | 0.75 × 10^6 cells/kg | A fully human anti-BCMA ScFv | 4-1BB | PiggyBac | P-BCMA-101 cells comprise a high percentage of Tscm cells and carry a selection gene and a “safety switch” gene. | Autologous | __ |
| 19 | Frigault MJ | 2020 | NCT04155749 | CART-Ddbcma | Phase 1, multicenter, open-label, dose-escalation | 10 | CP/Flu | 100 × 10^6 cells (6) | a non-human, non-immunoglobulin–derived BCMA-binding domain discovered from D domain phage display libraries | 4-1BB | __ | __ | __ | 208 days |
| 300 × 10^6 cells (4) | ||||||||||||||
| 20 | Hu Y | 2019 | ChiCTR-1800017404 | BCMA CAR-T | Phase 1, single-arm, open-label, single center | 33 | CP/Flu | 3.5 (1–6) ×10^6 cells/kg | __ | 4-1BB | Lentiviral | __ | Autologous | 8 month |
| 21 | Chunrui Li | 2021 | ChiCTR-OPC-16009113 | BCMA CAR-T | Phase I, single arm | 30 | CP20 mg/m2 + Flu25 mg/m2 daily for 3d | 11.2 × 10^6 cells/kg | A murine anti-BCMA ScFv | CD28 | Lentiviral | __ | Autologous | 385 days |