Table 2.
Clinical trials combining BiTEs and chemotherapy. B-ALL: B-cell acute lymphoblastic leukaemia; B-LLy: B-lymphoblastic lymphoma, r/r: relapsed or refractory, hyper-CVAD: hyperfractionated cyclophosphamide, vincristine sulphate, doxorubicin hydrochloride, and dexamethasone; mini-hyper-CVD: cyclophosphamide, vincristine, and dexamethasone; MRD: minimal residual disease; PRAME: preferentially expressed antigen of melanoma; ImmTAC: Immune mobilizing monoclonal T-cell receptors against cancer.
| BiTE | Chemotherapy | Phase | Study population | Identifier |
|---|---|---|---|---|
| Blinatumomab | Chemotherapy induction as per GIMEMA LAL1913 (NCT02067143) | III | Newly diagnosed standard risk B-ALL/B-LLy | NCT03914625 |
| Blinatumomab | Dexamethasone, filgrastim, pegfilgrastim, cyclophosphamide, methotrexate, cytarabine, and vincristine sulfate | II | r/r ALL | NCT03518112 |
| Blinatumomab | Intozumab-ozogamicin (anti CD22 antibody-drug conjugate) and hyper-CVAD | II | Newly diagnosed B-ALL | NCT02877303 |
| Blinatumomab | Condensed rituximab, intozumab-ozogamicin, and mini-hyper-CVD | II | Newly diagnosed B-ALL | NCT05645718 |
| Blinatumomab | Intozumab-ozogamicin | II | Newly diagnosed or r/r CD22 positive B-ALL | NCT03739814 |
| Blinatumomab | Condensed rituximab, intozumab-ozogamicin, and mini-hyper-CVD | II | Paediatric r/r B-ALL | NCT05645718 |
| Blinatumomab | Intozumab-ozogamicin and mini-hyper-CVD | I/II | Frontline B-ALL | NCT01371630 |
| Blinatumomab | +/- Cyclophosphamide, cytarabine, daunorubicin, dexamethasone, etoposide, mercaptopurine, methotrexate, pegaspargase, prednisone, rituximab, vincristine | III | Consolidation therapy for MRD-negative B-ALL | NCT02003222 |
| Blinatumomab | Chemotherapy induction as per GIMEMA LAL1913 (NCT02067143) | II | B-ALL | NCT03367299 |
| Blinatumomab | Reduced dose standard of care chemotherapy (no details given) | II | Older adults with B-ALL | NCT03480438 |
| Blinatumomab | Blinatumomab and low-intensity chemotherapy (no details given) vs. standard of care alone (hyper-CVAD or as per GMALL protocol [39]) | III | Older adults with B-ALL | NCT04994717 |
| Blinatumomab | Induction with dexamethasone, cyclophosphamide, vincristine, daunorubicin, vindesine, methotrexate, etoposide, and cytarabine followed by consolidation as per GMALL protocol [39]. | II | Frontline B-ALL | NCT04554485 |
|
IMC-F106
(CD3xPRAME) |
Chemotherapy (no details given) | I/II | Advanced PRAME-positive cancers | NCT04262466 |