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T cell vaccination

Hadassah Medical Organization · Phase 3 active Biologic Under review

T cell vaccination is a Biologic drug developed by Hadassah Medical Organization. It is currently in Phase 3 development for Treatment of various types of cancer.

T cell vaccination stimulates the body's immune system to recognize and attack cancer cells.

Researchers have been studying T cell vaccination in various conditions, including COVID-19, Non-hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Mantle Cell Lymphoma, and HIV Infections, using different interventions such as the hAd5-S-Fusion+N-ETSD vaccine and CD19.CAR-multiVST. The concept of T-cell vaccination involves immunizing against autoreactive T cells, which is analogous to classical vaccination against infectious diseases, but targets a pathogenic T-cell population instead.

Likelihood of approval
61.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • Baseline phase 3 → approval rate +58.3pp
    Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
  • Oncology Phase 3 boost +3.0pp
    Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2028–2030
EMA EU 2029–2031 +0.7 yr
MHRA GB 2029–2031 +0.7 yr
Health Canada CA 2029–2032 +0.9 yr
TGA AU 2029–2032 +1.2 yr
PMDA JP 2029–2032 +1.5 yr
NMPA CN 2030–2033 +2.3 yr
MFDS KR 2029–2032 +1.4 yr
CDSCO IN 2029–2033 +1.8 yr
ANVISA BR 2030–2033 +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 nameT cell vaccination
SponsorHadassah Medical Organization
ModalityBiologic
Therapeutic areaOncology
PhasePhase 3

Mechanism of action

This is achieved through the introduction of antigens from cancer cells to T cells, which then recognize and target these cells for destruction. The goal is to induce a long-term immune response against cancer cells.

Approved indications

Common side effects

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 T cell vaccination

What is T cell vaccination?

T cell vaccination is a Biologic drug developed by Hadassah Medical Organization, indicated for Treatment of various types of cancer.

How does T cell vaccination work?

T cell vaccination stimulates the body's immune system to recognize and attack cancer cells.

What is T cell vaccination used for?

T cell vaccination is indicated for Treatment of various types of cancer.

Who makes T cell vaccination?

T cell vaccination is developed by Hadassah Medical Organization (see full Hadassah Medical Organization pipeline at /company/hadassah-medical-organization).

What development phase is T cell vaccination in?

T cell vaccination is in Phase 3.

What are the side effects of T cell vaccination?

Common side effects of T cell vaccination include Injection site reactions, Fatigue, Pain.

Related

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