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Ex-vivo expanded effector cells

Dartmouth-Hitchcock Medical Center · Phase 2 active Biologic Quality 35/100

Ex-vivo expanded effector cells is a Cell therapy Biologic drug developed by Dartmouth-Hitchcock Medical Center. It is currently in Phase 2 development.

Immune effector cells are collected from patients, expanded in laboratory culture to increase their numbers, then reinfused to enhance immune response.

Likelihood of approval
15.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 2 → approval rate +15.3pp
    Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2031–2034
EMA EU 2032–2035 +0.7 yr
MHRA GB 2032–2035 +0.7 yr
Health Canada CA 2032–2036 +0.9 yr
TGA AU 2032–2036 +1.2 yr
PMDA JP 2032–2036 +1.5 yr
NMPA CN 2033–2037 +2.3 yr
MFDS KR 2032–2036 +1.4 yr
CDSCO IN 2032–2037 +1.8 yr
ANVISA BR 2033–2037 +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 nameEx-vivo expanded effector cells
SponsorDartmouth-Hitchcock Medical Center
Drug classCell therapy
ModalityBiologic
PhasePhase 2

Mechanism of action

The therapy involves harvesting immune effector cells from a patient, culturing them ex-vivo to dramatically increase their population, and then reinfusing the expanded cells back into the patient. This approach aims to boost the patient's immune system by providing a larger army of functional immune cells.

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Ex-vivo expanded effector cells

What is Ex-vivo expanded effector cells?

Ex-vivo expanded effector cells is a Cell therapy drug developed by Dartmouth-Hitchcock Medical Center.

How does Ex-vivo expanded effector cells work?

Immune effector cells are collected from patients, expanded in laboratory culture to increase their numbers, then reinfused to enhance immune response.

Who makes Ex-vivo expanded effector cells?

Ex-vivo expanded effector cells is developed by Dartmouth-Hitchcock Medical Center (see full Dartmouth-Hitchcock Medical Center pipeline at /company/dartmouth-hitchcock-medical-center).

What drug class is Ex-vivo expanded effector cells in?

Ex-vivo expanded effector cells belongs to the Cell therapy class. See all Cell therapy drugs at /class/cell-therapy.

What development phase is Ex-vivo expanded effector cells in?

Ex-vivo expanded effector cells is in Phase 2.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing