Last reviewed 2026-05-18 · How we verify

Allo-QuadCAR01-T

AvenCell Therapeutics, Inc. · Phase 2 active Small molecule Quality 35/100

Allo-QuadCAR01-T is a CAR-T cell therapy Small molecule drug developed by AvenCell Therapeutics, Inc.. It is currently in Phase 2 development.

Allogeneic CAR-T cells engineered to target four tumor-associated antigens simultaneously for enhanced cancer cell recognition and elimination.

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 name	Allo-QuadCAR01-T
Sponsor	AvenCell Therapeutics, Inc.
Drug class	CAR-T cell therapy
Modality	Small molecule
Phase	Phase 2

Mechanism of action

Allo-QuadCAR01-T uses donor-derived T cells modified to express four different chimeric antigen receptors (CARs), enabling recognition of multiple tumor surface markers. This multi-targeting approach may reduce tumor escape and improve efficacy compared to single-target CAR-T therapies.

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.

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:

Allo-QuadCAR01-T CI brief — competitive landscape report
Allo-QuadCAR01-T updates RSS · CI watch RSS
AvenCell Therapeutics, Inc. portfolio CI

Frequently asked questions about Allo-QuadCAR01-T

What is Allo-QuadCAR01-T?

Allo-QuadCAR01-T is a CAR-T cell therapy drug developed by AvenCell Therapeutics, Inc..

How does Allo-QuadCAR01-T work?

Allogeneic CAR-T cells engineered to target four tumor-associated antigens simultaneously for enhanced cancer cell recognition and elimination.

Who makes Allo-QuadCAR01-T?

Allo-QuadCAR01-T is developed by AvenCell Therapeutics, Inc. (see full AvenCell Therapeutics, Inc. pipeline at /company/avencell-therapeutics-inc).

What drug class is Allo-QuadCAR01-T in?

Allo-QuadCAR01-T belongs to the CAR-T cell therapy class. See all CAR-T cell therapy drugs at /class/car-t-cell-therapy.

What development phase is Allo-QuadCAR01-T in?

Allo-QuadCAR01-T is in Phase 2.

Drug class: All CAR-T cell therapy drugs
Manufacturer: AvenCell Therapeutics, Inc. — full pipeline

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