Basiliximab
| Evidence Level: L2 | Predicted Indications: 10 |
Table of Contents
Basiliximab: From Transplant Immunosuppression to Plasma Cell Myeloma
One-Sentence Summary
Basiliximab is an anti-CD25 (IL-2 receptor alpha chain) monoclonal antibody, marketed in Singapore as Simulect. The TxGNN model predicts it may be useful for plasma cell myeloma, but only as immunomodulatory support around stem cell transplantation, not as a direct anti-myeloma drug. Currently 3 clinical trials (all small) and 4 publications support this direction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the Singapore licence data compiled for this report |
| Predicted New Indication | Plasma cell myeloma |
| TxGNN Prediction Score | 95.61% |
| Evidence Level | L2 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 1 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Basiliximab blocks the IL-2 receptor alpha chain (CD25) on activated T cells. In myeloma transplant settings, it is used to deplete activated T cells and regulatory T cells (Tregs). The goals are either to prevent graft-versus-host disease (GVHD) after non-myeloablative allogeneic transplantation, or to enhance anti-tumour immunity after autologous transplantation, where rapidly recovering Tregs may suppress immune responses against myeloma cells.
The link is therefore supportive and immunomodulatory, not a direct anti-myeloma effect. Basiliximab's established use is in preventing transplant rejection, and the prediction reflects its use around myeloma transplants rather than treatment of the cancer itself. Detailed mechanism-of-action data are not available in the data compiled for this report, so this explanation relies on the described mechanistic rationale.
Other predictions are much weaker. Bronchitis appears to reflect a mapping to bronchiolitis obliterans after lung transplantation. Indolent myeloma, gastric carcinoma, diffuse gastric adenocarcinoma and several rare genetic conditions have no supporting trials or literature. Hemoglobinopathy (thalassemia major) has trial evidence, but only for GVHD prevention in transplantation.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT00975975 | Phase 2 | Completed | 17 | Basiliximab plus cyclosporine to prevent GVHD after non-myeloablative allotransplant in blood cancers including myeloma; small single-arm study |
| NCT01526096 | Phase 1 | Completed | 30 | Pilot of regulatory T-cell depletion in autologous stem cell transplantation for myeloma; focused on feasibility, safety and immune effects |
| NCT00594308 | Phase NA | Terminated | 10 | Basiliximab plus cyclosporine vs cyclosporine alone for GVHD prevention; early termination limits interpretation |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 12476283 | 2002 | Cohort | Bone Marrow Transplant | Basiliximab was well tolerated and effective in 17 patients with steroid-refractory acute GVHD after allogeneic transplantation (one patient with myeloma) |
| 31940591 | 2020 | Cohort (pilot) | J Immunother Cancer | Regulatory T-cell depletion around autologous transplantation for myeloma, based on the idea that rapidly reconstituting Tregs inhibit anti-myeloma immunity |
| 28320553 | 2017 | Case report | Am J Kidney Dis | Four patients with kidney failure from myeloma underwent kidney transplantation after treatment response |
| 42379467 | 2026 | Case report/Review | Am J Kidney Dis | Kidney transplantation after CAR T-cell therapy in myeloma; context for transplant in selected patients |
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN10441P | SIMULECT FOR INJECTION 20 mg/vial | Injection, powder, for solution | Not stated in the data compiled |
Safety Considerations
Drug Interactions: 69 interactions were identified in the data compiled for this report. Examples include:
- Major: adalimumab, baricitinib, certolizumab pegol, BCG live vaccine (additive immunosuppression and infection risk)
- Moderate: alemtuzumab, anakinra, azathioprine, canakinumab, roflumilast, several vaccines
- Minor: zinc salts
Package insert warnings and contraindications were not available. Please refer to the package insert for further safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The evidence is limited to small early-phase or single-arm studies of basiliximab as transplant-supportive immunomodulation, not as treatment of myeloma. The TxGNN score is high, but the clinical support is exploratory, and no Phase 3 data exist. Enrolled populations are mixed, and the best-matched trial is a Phase 1 pilot.
To proceed, the following is needed:
- Package insert warnings and contraindications from the HSA, and the approved indications for Simulect in Singapore
- Mechanism-of-action data from DrugBank
- Results and outcomes from NCT00975975 and NCT01526096, and any comparative data in myeloma transplant populations
- A clear research question defining whether the aim is GVHD prevention or Treg depletion for anti-myeloma immunity
- An infection-risk and immunosuppression review given the many major interactions
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.