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BAFFR CAR-T
BAFFR CAR-T is a CAR-T cell therapy Biologic drug developed by Guangzhou Bio-gene Technology Co., Ltd. It is currently in Phase 1 development for Relapsed or refractory B-cell non-Hodgkin lymphoma.
CAR-T cell therapy targeting BAFFR
CAR-T cell therapy targeting BAFFR Used for Relapsed or refractory B-cell non-Hodgkin lymphoma.
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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 | BAFFR CAR-T |
|---|---|
| Sponsor | Guangzhou Bio-gene Technology Co., Ltd |
| Drug class | CAR-T cell therapy |
| Target | BAFFR |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 1 |
Mechanism of action
BAFFR CAR-T is a type of immunotherapy that uses genetically modified T cells to target and kill cancer cells expressing BAFFR.
Approved indications
- Relapsed or refractory B-cell non-Hodgkin lymphoma
Common side effects
- Cytokine release syndrome
- Neutropenia
- Anemia
Key clinical trials
- Safety and Efficacy Study of BAFF-R CAR-T Cells in Adult Subjects With CD19-Negative Relapsed or Refractory B-Cell Lymphoma (PHASE1)
- B-Cell Activating Factor Receptor (BAFFR)-Based Chimeric Antigen Receptor T-Cells With Fludarabine and Cyclophosphamide Lymphodepletion for the Treatment of Relapsed or Refractory B-cell Hematologic Malignancies (PHASE1)
- BAFFR Targeting CAR-T Cells for the Treatment of Relapsed or Refractory B-cell ALL (PHASE1)
- CD19/BAFF-R in Vivo CAR-T Cell Therapy Targeting Relapsed/Refractory B Cell Acute Leukemia/Malignant Lymphoma (PHASE1)
- Clinical Study Evaluating the Safety and Efficacy of BAFFR CAR-T Therapy for Relapsed/Refractory B-cell Malignancies (NA)
- Multicenter, Single-Arm Exploratory Phase I Clinical Study (Assessment of Safety and Efficacy) of Fully Human BAFF-R Chimeric Antigen Receptor T-Cell Injection in Relapsed/Refractory BAFF-R-Positive B-Cell Lymphoma (PHASE1, PHASE2)
- BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-NHL (PHASE1)
- BAFFR CAR-T Treatment for Relapsed/Refractory B-cell Tumors (EARLY_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:
- BAFFR CAR-T CI brief — competitive landscape report
- BAFFR CAR-T updates RSS · CI watch RSS
- Guangzhou Bio-gene Technology Co., Ltd portfolio CI
Frequently asked questions about BAFFR CAR-T
What is BAFFR CAR-T?
How does BAFFR CAR-T work?
What is BAFFR CAR-T used for?
Who makes BAFFR CAR-T?
What drug class is BAFFR CAR-T in?
What development phase is BAFFR CAR-T in?
What are the side effects of BAFFR CAR-T?
What does BAFFR CAR-T target?
Related
- Drug class: All CAR-T cell therapy drugs
- Target: All drugs targeting BAFFR
- Manufacturer: Guangzhou Bio-gene Technology Co., Ltd — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Relapsed or refractory B-cell non-Hodgkin lymphoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing