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CD38 CAR T-cells
CD38 CAR T-cells is a Biologic drug developed by Zhejiang University. It is currently in Phase 1 development.
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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 | CD38 CAR T-cells |
|---|---|
| Sponsor | Zhejiang University |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma (PHASE2)
- Plan Development for Giving Teclistamab in the Outpatient Setting (PHASE4)
- Combination CAR-T Cell Therapy Targeting Hematological Malignancies (PHASE1, PHASE2)
- Clinical Study of U32 in Patients With Acute Myeloid Leukemia (PHASE1, PHASE2)
- A Clinical Study to Evaluate the Safety and Efficacy of CLL1 and CD38 Dual-Target CAR-T Cell Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (PHASE1)
- The Predictability of CD19 Expression Across Primitive Cellular Fractions of Relapsed B-ALL on Outcomes of CD19-targeted CAR T-cells
- Clinical Study of CD38\CS1 Chimeric Antigen Receptor T Cells in the Treatment of Refractory/Recurrent Multiple Myeloma (EARLY_PHASE1)
- CAR-T Cells Therapy in Relapsed/Refractory Multiple Myeloma (NA)
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:
- CD38 CAR T-cells CI brief — competitive landscape report
- CD38 CAR T-cells updates RSS · CI watch RSS
- Zhejiang University portfolio CI
Frequently asked questions about CD38 CAR T-cells
What is CD38 CAR T-cells?
Who makes CD38 CAR T-cells?
What development phase is CD38 CAR T-cells in?
Related
- Manufacturer: Zhejiang University — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing