Last reviewed · How we verify
EBV-specific T cells: A
EBV-specific T cells: A is a Adoptive cell therapy Biologic drug developed by Baylor College of Medicine. It is currently in Phase 1 development. Also known as: LMP, BARF1 and EBNA1 specific CTLs.
Adoptive transfer of T cells specifically engineered or selected to recognize and eliminate cells infected with or transformed by Epstein-Barr virus.
EBV-specific T cells are being studied as a treatment for various conditions, including EBV-related Hodgkin lymphoma, lymphoproliferative disorder, non-Hodgkin's lymphoma, chronic active Epstein-Barr virus infection, and virus-associated hemophagocytic syndrome. EBV-specific T cells are administered as a form of somatic cell supplemental therapy, where a specific dose of cells is given to the patient, with doses ranging from 2 x 10^7 cells/m2 to 6 x 10^7 cells/m2.
-
Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | EBV-specific T cells: A |
|---|---|
| Also known as | LMP, BARF1 and EBNA1 specific CTLs |
| Sponsor | Baylor College of Medicine |
| Drug class | Adoptive cell therapy |
| Modality | Biologic |
| Phase | Phase 1 |
Mechanism of action
The therapy involves isolating and expanding T cells that recognize EBV-associated antigens. When infused into patients, these cells seek out and destroy EBV-infected or EBV-transformed cells through cytotoxic immune responses, providing targeted immunotherapy for EBV-related diseases.
Approved indications
Common side effects
Key clinical trials
- Most Closely Matched 3rd Party Rapidly Generated LMP, BARF1 And EBNA1 Specific CTL, EBV-Positive Lymphoma (MABEL) (PHASE1)
- Donor-Derived EBV-Specific T Cells for Life Threatening EBV-lymphoma (OLIP-EBV-TCL-01-HMR01) (NA)
- T-Lymphocytes for Prevention or Treatment of Viral Infections Following Hematopoietic Stem Cell Transplantation (PHASE1)
- Early Clinical Study on the Use of Donor-derived EBV-specific T Cells for the Prevention of EBV Infection After Allogeneic Hematopoietic Stem Cell Transplantation (EARLY_PHASE1)
- EBV-AST Cell Injection for EBV-Associated Lymphoproliferative Disorders (PHASE1, PHASE2)
- Cytotoxic T-Lymphocytes for EBV-positive Lymphoma, GRALE (PHASE1)
- A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy (PHASE3)
- A Study to Evaluate Tabelecleucel in Participants With Epstein Barr Virus (EBV) Associated Diseases (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- EBV-specific T cells: A CI brief — competitive landscape report
- EBV-specific T cells: A updates RSS · CI watch RSS
- Baylor College of Medicine portfolio CI
Frequently asked questions about EBV-specific T cells: A
What is EBV-specific T cells: A?
How does EBV-specific T cells: A work?
Who makes EBV-specific T cells: A?
Is EBV-specific T cells: A also known as anything else?
What drug class is EBV-specific T cells: A in?
What development phase is EBV-specific T cells: A in?
Related
- Drug class: All Adoptive cell therapy drugs
- Manufacturer: Baylor College of Medicine — full pipeline
- Also known as: LMP, BARF1 and EBNA1 specific CTLs
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing