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Autologous T cells-Based Immunotherapy
Autologous T cells-Based Immunotherapy is a Biologic drug developed by Shanghai AbelZeta Ltd.. It is currently in Phase 1 development. Also known as: TCM.
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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 | Autologous T cells-Based Immunotherapy |
|---|---|
| Also known as | TCM |
| Sponsor | Shanghai AbelZeta Ltd. |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors (PHASE1, PHASE2)
- Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia (NA)
- Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies (PHASE1)
- T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer (PHASE2)
- Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer (PHASE2)
- Tisagenlecleucel in Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma (PHASE3)
- IL13Rα2 CAR-T Cells Secreting Anti-PD-L1 Antibody for Recurrent Malignant Glioma (PHASE1)
- Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2/IL-13Ralpha2 CAR (E-SYNC) T Cells (PHASE1)
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:
- Autologous T cells-Based Immunotherapy CI brief — competitive landscape report
- Autologous T cells-Based Immunotherapy updates RSS · CI watch RSS
- Shanghai AbelZeta Ltd. portfolio CI
Frequently asked questions about Autologous T cells-Based Immunotherapy
What is Autologous T cells-Based Immunotherapy?
Who makes Autologous T cells-Based Immunotherapy?
Is Autologous T cells-Based Immunotherapy also known as anything else?
What development phase is Autologous T cells-Based Immunotherapy in?
Related
- Manufacturer: Shanghai AbelZeta Ltd. — full pipeline
- Also known as: TCM
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing