Last reviewed 2026-05-30 · How we verify

TSC-204-A0101

TScan Therapeutics, Inc. · Phase 1 active Biologic ✓ Verified May 2026

TSC-204-A0101 is a Biologic drug developed by TScan Therapeutics, Inc.. It is currently in Phase 1 development.

TSC-204-A0101 is a small molecule being studied in a Phase 1 basket study for the treatment of various solid tumors, including Head and Neck Cancer, Cervical Cancer, Non-small Cell Carcinoma, Melanoma, and Ovarian Cancer. This study is evaluating the safety and feasibility of T-Plex, a customized autologous TCR-T cell therapy, in patients with locally advanced or metastatic solid tumors.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	TSC-204-A0101
Sponsor	TScan Therapeutics, Inc.
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid Tumors (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:

TSC-204-A0101 CI brief — competitive landscape report
TSC-204-A0101 updates RSS · CI watch RSS
TScan Therapeutics, Inc. portfolio CI

Frequently asked questions about TSC-204-A0101

What is TSC-204-A0101?

TSC-204-A0101 is a Biologic drug developed by TScan Therapeutics, Inc..

Who makes TSC-204-A0101?

TSC-204-A0101 is developed by TScan Therapeutics, Inc. (see full TScan Therapeutics, Inc. pipeline at /company/tscan-therapeutics-inc).

What development phase is TSC-204-A0101 in?

TSC-204-A0101 is in Phase 1.

Manufacturer: TScan Therapeutics, Inc. — full pipeline

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