Teclistamab
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | DRUG-TECLISTAMAB |
|---|---|
| Type | Drug |
| Aliases | TecvayliТеклістамаб |
| Status | reviewed 2026-04-25 | pending_clinical_signoff |
| Diseases | DIS-MM |
| Sources | SRC-NCCN-MM-2025 |
Drug Facts
| Class | BCMA × CD3 bispecific T-cell engager (BiTE-class IgG) |
|---|---|
| Mechanism | Humanized IgG4 bispecific antibody binding BCMA (B-cell maturation antigen, expressed on plasma cells + myeloma) on one arm and CD3 on cytotoxic T-cells on the other. Forms immune synapse → T-cell activation, cytokine release + targeted plasma-cell killing independent of TCR specificity. First off-the-shelf bispecific approved for triple-class refractory multiple myeloma. |
| Typical dosing | Step-up dosing required (CRS mitigation): 0.06 mg/kg SC day 1, 0.3 mg/kg SC day 4, 1.5 mg/kg SC day 7 — minimum 48h between doses. Full dose: 1.5 mg/kg SC weekly until progression. May transition to every-2-weeks after ≥6 months sustained ≥VGPR (MajesTEC-1 protocol amendment). |
| Ukraine registered | False |
| NSZU reimbursed | False |
| Ukraine last verified | 2026-04-27 |
Warnings
- Cytokine release syndrome (CRS) — 72% any grade, ~1% Grade ≥3 in MajesTEC-1
- Neurologic toxicity / ICANS (~14%)
- Serious infections — Grade ≥3 ~45%; opportunistic + bacterial; hypogammaglobulinemia universal
- Hepatotoxicity
Notes
MajesTEC-1 (Moreau 2022): triple-class refractory MM after ≥3 prior lines (median 5) — ORR 63%, CR 39%, mPFS ~11 mo, mDOR ~22 mo. Approved 4L+ triple-class refractory. Hospitalization REQUIRED for step-up doses (CRS observation 48h after each). Tocilizumab + corticosteroids for CRS management. Mandatory PJP + HSV prophylaxis; IVIG supplementation for IgG <400 (universal hypogammaglobulinemia). Bispecifics are substantially more toxic than CAR-T in infection burden — serial infection screening every visit.
Used By
Regimens
REG-TECLISTAMAB- Teclistamab BCMA × CD3 bispecific (with step-up dosing) — continuous SC weeklyREGIMEN-TECLISTAMAB-MONO-MM- Teclistamab BCMA × CD3 bispecific monotherapy — continuous SC weekly (post step-up)REGIMEN-TECLISTAMAB-STEP-UP-DOSING-MM- Teclistamab BCMA × CD3 bispecific — inpatient step-up dosing schedule