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T-Cell Infusion Dose Level -1
T-Cell Infusion Dose Level -1 is a Cellular Immunotherapy Biologic drug developed by Baylor College of Medicine. It is currently in Phase 1 development.
Infusion of T-cells to enhance immune response against disease targets.
There is no information provided about T-Cell Infusion Dose Level -1. However, based on the given facts, T-Cell Infusion is being studied in various conditions including Rhabdomyosarcoma, Gastrointestinal Tumors, Leukemia, Multiple Myeloma, and Sickle Cell Disease.
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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 | T-Cell Infusion Dose Level -1 |
|---|---|
| Sponsor | Baylor College of Medicine |
| Drug class | Cellular Immunotherapy |
| Modality | Biologic |
| Phase | Phase 1 |
Mechanism of action
The therapy involves administering T-cells, which are immune cells that can recognize and attack specific targets. Dose Level -1 represents a de-escalated dose tier, typically used in Phase 1 trials when standard starting doses show toxicity concerns.
Approved indications
Common side effects
Key clinical trials
- Metabolically Fit CD19 CAR T-cell Therapy With CD34 Selection in Patients With CD19+ Relapsed/Refractory NHL, CLL/SLL (PHASE1, PHASE2)
- ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors (PHASE1, PHASE2)
- A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma (PHASE3)
- RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy (PHASE2, PHASE3)
- GB-5267 for the Treatment Platinum-Resistant Ovarian, Peritoneal, or Fallopian Tube Cancer (PHASE1)
- Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID) (PHASE1, PHASE2)
- Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers (PHASE1, PHASE2)
- Study of CAR T-Cells Targeting the GD2 With IL-15+iCaspase9 for Relapsed/Refractory Neuroblastoma or Relapsed/Refractory Osteosarcoma (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:
- T-Cell Infusion Dose Level -1 CI brief — competitive landscape report
- T-Cell Infusion Dose Level -1 updates RSS · CI watch RSS
- Baylor College of Medicine portfolio CI
Frequently asked questions about T-Cell Infusion Dose Level -1
What is T-Cell Infusion Dose Level -1?
How does T-Cell Infusion Dose Level -1 work?
Who makes T-Cell Infusion Dose Level -1?
What drug class is T-Cell Infusion Dose Level -1 in?
What development phase is T-Cell Infusion Dose Level -1 in?
Related
- Drug class: All Cellular Immunotherapy drugs
- Manufacturer: Baylor College of Medicine — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing