Table 3.
BsAb studies in R/R aNHL patients without published results.
| Clinical Trial | Phase | Drug(s) | Histology | Comments | Primary Endpoints | Key Secondary endpoints | Estimated Enrollment |
|---|---|---|---|---|---|---|---|
| Planned ASCS Consolidation | |||||||
| NCT05464329 | I | MOSUNETUZUMAB + DHAX/ICE | B-NHL | Planned ASCS after cycle 3 | Frequencies and grades of TEAEs | CR rates; PFS and OS | 40 |
| NCT05852717 | II | EPCORITAMAB + GDP | DLBCL | Planned ASCS after cycle 3 | CR rates | ORR; PFS, DOR and OS; feasibility of ASCS or CAR-T cell consolidation | 32 |
| NCT05364424 | I | GLOFITAMAB + R-ICE | DLBCL | Planned ASCS after cycle 3 | ORR | CR rates; PFS, DOR and OS; TEAEs | 40 |
| Planned CAR-T Consolidation | |||||||
| NCT05260957 | II | MOSUNETUZUMAB + POLATUZUMAB | B-NHL | Mosunetuzumab + Anti-CD79b ADC; Planned CAR-T therapy after cycle 8 | CR rates | ORR; PFS, DOR and OS; CRS and ICANS rates following CAR-T | 40 |
| NCT05852717 | II | EPCORITAMAB + GDP | DLBCL | Planned CAR-T therapy after cycle 3 | CR rates | ORR; PFS, DOR and OS; feasibility of ASCS or CAR-T cell consolidation | 32 |
| No Consolidation Planned: Single Agent | |||||||
| NCT05412290 | I | MOSUNETUZUMAB | B-NHL | Administered following ASCS | Frequencies and grades of TEAEs | PFS and OS following ASCS | 15 |
| NCT04889716 | II | MOSUNETUZUMAB | B-NHL | Administered following CAR-T | CR rates; DLT | PFS, DOR and OS | 42 |
| NCT03677154 | I/II | MOSUNETUZUMAB | DLBCL | Administered either SC or IV following 1st line therapy | CR rates; ORR; frequencies and grades of TEAEs | PFS, DOR and OS; quality of life | 188 |
| NCT05451810 | II | EPCORITAMAB | B-NHL | Administered as Outpatient | Frequencies and grades of TEAEs | CR rates; best ORR; PFS, DOR and OS | 184 |
| NCT04628494 | III | EPCORITAMAB vs chemotherapy | DLBCL | Investigator’s choice as control arm, either BR or R-GemOx | OS | CR rates; ORR; PFS, DOR and TTNT; rate and duration of MRD negative status; TEAEs; quality of life | 552 |
| NCT04703686 | II | GLOFITAMAB | B-NHL | For patients with relapse after CAR-T | OS | CR rates; ORR; PFS, DOR; quality of life | 78 |
| NCT05619367 | ODRONEXTAMAB | B-NHL | Compassionate use program | N/A | N/A | N/A | |
| NCT05991388 | II | ODRONEXTAMAB | B-NHL | For pediatric and young adult patients | CR rates; ORR | PFS, DOR and OS; frequencies and grades of TEAEs | 210 |
| No Consolidation Planned: Combinations with Chemotherapeutic Agents | |||||||
| NCT04313608 | I | MOSUNETUZUMAB/GLOFITAMAB + GemOx | DLBCL | 8 cycles of combined therapy. Glofitamab monotherapy continued until C12 |
Frequencies and grades of TEAEs | CR rates; ORR; pharmacokinetics | 23 |
| NCT05533775 | I/II | GLOFITAMAB + R-ICE | B-NHL | Pediatric and young adult patients | CR rates; frequencies and grades of TEAEs | ORR; PFS, DOR and OS | 65 |
| NCT04408638 | III | GLOFITAMAB + GemOx vs R-GemOx |
DLBCL | 8 cycles of combined therapy. Glofitamab monotherapy continued until C12 |
OS | ORR; PF and DOR; frequencies and grades of TEAEs; quality of life | 270 |
| No Consolidation Planned: Combinations with Non-Chemotherapeutic Agents | |||||||
| NCT04970901 | I | MOSUNETUZUMAB/GLOFITAMAB + LONCASTUXIMAB | B-NHL | Mosunetuzumab/Glofitamab + anti-CD19 ADC | Frequencies and grades of TEAEs | CR rates; ORR; PFS, DOR; pharmacokinetics | 200 |
| NCT05672251 | II | MOSUNETUZUMAB + LONCASTUXIMAB | DLBCL | Mosunetuzumab + anti-CD19 ADC | ORR; Frequencies and grades of TEAEs | CR rates; ORR; PFS, DOR; TEAEs | 36 |
| NCT05171647 | III | MOSUNETUZUMAB + POLATUZUMAB vs R-GemOx |
B-NHL | Mosunetuzumab + anti-CD79b ADC | PFS | CR rates; ORR; DOR and OS; TEAEs; quality of life | 222 |
| NCT05315713 | I/II | MOSUNETUZUMAB + TIRAGOLUMAB ± ATEZOLIZUMAB | B-NHL | Mosunetuzumab + anti-TIGIT Ab ± anti-PDL1 Ab | Frequencies and grades of TEAEs; ORR | CR rate; PFS, DOR and OS | 118 |
| NCT05615636 | II | MOSUNETUZUMAB + POLATUZUMAB + TAFASITAMAB + LENALIDOMIDE | DLBCL | Mosunetuzumab + anti-CD79b ADC + anti-CD19 Ab + immune modulator | Best ORR | N/A | 36 |
| NCT05169515 | I | MOSUNETUZUMAB + CC-220 MOSUNETUZUMAB + CC-99282 GLOFITAMAB + CC-99282 |
B-NHL | Mosunetuzumab/Glofitamab + cereblon E3 ligase modulator (CELMoD) | Best ORR; DLT; frequencies and grades of TEAEs | Best CR rate; PFS, DOR and OS up to 2 y; serum concentration of CC-220 and CC-99282 | 121 |
| NCT05283720a | I/II | EPCORITAMAB + immuno-modulating agents | B-NHL | Multi-arm study. | DLT | Best ORR; CR rates; PFS, DOR, OS and TTNT up to 5 y; rate and duration of MRD negative status | 394 |
| NCT04077723 | I/II | GLOFITITAMAB + RO7227166 | B-NHL | Glofitamab + CD19×CD137 BsAb | DLT; TEAEs; CR rates; ORR; PFS, DOR and OS | Pharmacokinetics; quality of life | 46 |
| NCT05219513 | I | GLOFITAMAB + RO7443904 | B-NHL | Glofitamab + CD19×CD28 BsAb | Frequencies and grades of TEAEs | Pharmacokinetics | 200 |
| NCT05896163 | I/II | GLOFITAMAB + MAPLIRPACEPT | DLBCL | Glofitamab + anti-CD47 Ab | DLT; ORR | CR rates; PFS and DOR; TEAEs | 70 |
| NCT02651662 | I | ODRONEXTAMAB + CEMIPLIMAB | B-NHL | Odronextamab + anti-PD1 Ab | Frequencies and grades of TEAEs | CR rates; ORR; DOR | 62 |
| NCT05685173 | I | ODRONEXTAMAB + REGN5837 | B-NHL | Odronextamab + CD22×CD28 BsAb | Frequencies and grades of TEAEs | CR rates; ORR; PFS, DOR and OS | 91 |
| NCT05328102 | II | PLAMOTAMAB + TAFASITAMAB + LENALIDOMIDE vs TAFASITAMAB + LENALIDOMIDE |
DLBCL | Study terminated early by the sponsor | frequencies and grades of TEAEs; PFS | N/A | 3 |
| Novel Constructs | |||||||
| NCT05210868 | I/II | CM355 | B-NHL | CD3×CD20 BsAb | frequencies and grades of TEAEs; ORR | CR rates; ORR; PFS, DOR and OS; pharmacokinetics endpoints | 184 |
| NCT05618327 | I | JS203 | B-NHL | CD3×CD20 BsAb | DLT | CR rates; ORR; PFS, DOR and OS; TEAEs; pharmacokinetics | 219 |
| NCT04056975 | I | A-319 | B-NHL | CD3×CD19 BsAb | Frequencies and grades of TEAEs | Pharmacokinetics endpoints | 54 |
| NCT04540796 | I | JNJ-75348780 | B-NHL | CD3×CD22 BsAb | Frequencies and grades of TEAEs | CR rates; ORR; DOR; pharmacokinetics | 148 |
| NCT05424822 | I | JNJ-80948543 | B-NHL | CD3×CD20×CD79b TsAb | Frequencies and grades of TEAEs | CR rates; ORR; DOR | 180 |
| NCT05348889 | I | CMG1A46 | B-NHL | CD3×CD19×CD20 TsAb | Frequencies and grades of TEAEs | CR rates; ORR; PFS and OS; pharmacokinetics | 165 |
| NCT05397496 | I | PIT565 | B-NHL | CD3×CD2×CD19 TsAb | Frequencies and grades of TEAEs | CR rates; ORR; PFS, DOR; pharmacokinetics | 140 |
| NCT05623982 | I/II | EMFIZATAMAB | B-NHL | CD3×CD137×PD-L1×CD19 TesAb | Frequencies and grades of TEAEs | CR rates; ORR; PFS, DOR and OS; pharmacokinetics | 40 |
| NCT06088654 | I/II | IPH6501 | B-NHL | NKp46×CD16a×CD122×CD20 TesAb | Frequencies and grades of TEAEs | ORR; DOR and PFS; pharmacokinetics | 184 |
Reported abstract data refer to the time of their publication. DLBCL includes DLBCL, not otherwise specified, high-grade B-cell lymphoma, and transformed indolent NHL.
aEpcoritamab investigated in combination with multiple agents across different histologies (DLBCL, FL, MZL). For r/r DLBCL patients, combination therapies encompass lenalidomide, ibrutinib, and CC-99282.
Abbreviations: TEAEs, treatment-emergent adverse events; ADAs, anti-drug antibodies; DLT, dose-limiting toxicity; SC, subcutaneous; IV, intravenous; PFS, progression-free survival; DOR, duration of response; TTNT, time to next treatment; OS, overall survival; ASCS, autologous stem cell support; CAR-T, chimeric antigen receptor T-cell; Cmax, maximum serum concentration; AUC, area under the curve; EORTC, European Organisation for Research and Treatment of Cancer; FACT-Lym, functional assessment of cancer therapy-lymphoma; DHAX, dexamethasone, cytarabine, oxaliplatin; R-ICE, rituximab, ifosfamide, carboplatin, etoposide; GDP, gemcitabine, dexamethasone, cisplatin; R-GemOx, rituximab, gemcitabine, oxaliplatin; BR, bendamustine, rituximab; Ab, antibody; ADC, antibody–drug conjugate; MRD, minimal residual disease; ORR, overall response rate; CR, complete remission; SD, stable disease; PR, partial response; N/A, not assessed; TsAb, trispecific antibody; TesAb, tetraspecific antibody.