Last reviewed · How we verify
Regulator T Cells
Regulator T Cells is a Small molecule drug developed by Xuzhou Medical University. It is currently in Phase 1 development. Also known as: Regulatory T-Lymphocytes.
Regulator T cells are studied in clinical trials for various conditions, including hematologic diseases, graft failure, and vitiligo, often in the context of allogeneic hematopoietic stem cell transplantation. The mechanism of regulator T cells is classified as somatic cell supplemental therapy, according to ChEMBL.
-
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 | Regulator T Cells |
|---|---|
| Also known as | Regulatory T-Lymphocytes |
| Sponsor | Xuzhou Medical University |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Fatigue
- Anemia
- Productive cough
- Dysphagia
- Neutrophil count decreased
- Dyspnea
- Esophagitis
- Pneumonitis
- Nausea
- Pruritus
- Pain
- Anorexia
Key clinical trials
- Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD (PHASE1)
- Study of CD19 t-haNK and NAI With Rituximab in Participants With Indolent Non-Hodgkin Lymphoma (PHASE2)
- Study of Relapsed/ Refractory B-cell Non- Hodgkin Lymphoma (PHASE2)
- Controlling Hyperactive Immunity With Long-lived Lymphocytes (PHASE1, PHASE2)
- Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab+Chemotherapy in Advanced Solid Tumors - Cohort C (PHASE1, PHASE2)
- Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies (PHASE3)
- INS, B Cells and Microbiota
- Combination Immunotherapy in Rare Cancers Under InvesTigation (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:
- Regulator T Cells CI brief — competitive landscape report
- Regulator T Cells updates RSS · CI watch RSS
- Xuzhou Medical University portfolio CI
Frequently asked questions about Regulator T Cells
What is Regulator T Cells?
Who makes Regulator T Cells?
Is Regulator T Cells also known as anything else?
What development phase is Regulator T Cells in?
What are the side effects of Regulator T Cells?
Related
- Manufacturer: Xuzhou Medical University — full pipeline
- Also known as: Regulatory T-Lymphocytes
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing