CLN3

Chr 16AR

CLN3 lysosomal/endosomal transmembrane protein, battenin

Also known as: BTN1, BTS, JNCL, RP101, SLC29B1

This gene encodes a protein that is involved in lysosomal function. Mutations in this, as well as other neuronal ceroid-lipofuscinosis (CLN) genes, cause neurodegenerative diseases commonly known as Batten disease or collectively known as neuronal ceroid lipofuscinoses (NCLs). Many alternatively spliced transcript variants have been found for this gene. [provided by RefSeq, Jul 2008]

GeneReviewsOMIMResearchGenerating clinical summary…

Primary Disease Associations & Inheritance

Ceroid lipofuscinosis, neuronal, 3MIM #204200
AR
Retinitis pigmentosa 101MIM #621548
AR
Ceroid lipofuscinosis, neuronal, 3MIM #204200
AR

Clinical highlights

Gene-disease validity (ClinGen)
neuronal ceroid lipofuscinosis · ARDefinitivesufficient evidence for diagnostic panels
Interpreting a novel variant
Loss of function is the established mechanism, though the gene is not strongly LoF-constrained in the population — weigh truncating variants against that tolerance.Curated gene-level mechanism — a prior for triage, not a per-variant call.
11
Active trials
57
Pubs (1 yr)
P/LP submissions
P/LP missense
0.91
LOEUF
LOF
Mechanism· annotated
📖
GeneReview available — CLN3
Authoritative clinical overview · Recommended first read
Open GeneReview ↗

Population Genetics & Constraint

gnomAD v4 — loss-of-function & missense intolerance

Tolerant — LoF & missense variants common in population
LoF Constraint?
0.91LOEUF
pLI 0.000
Z-score 1.93
OE 0.59 (0.390.91)
Tolerant

Typical tolerance to LoF variation

Missense Constraint?
-0.15Z-score
OE missense 1.03 (0.931.14)
255 obs / 248.5 exp
Tolerant

Tolerant to missense variation

Observed / Expected Ratios?
LoF OE?0.59 (0.390.91)
00.351.4
Missense OE?1.03 (0.931.14)
00.61.4
Synonymous OE?1.13
01.21.6
LoF obs/exp: 15 / 25.5Missense obs/exp: 255 / 248.5Syn Z: -1.08

ClinVar Variant Classifications

0 submitted variants in ClinVar

Protein Context — Lollipop Plot

CLN3 · protein map & ClinVar variants

Showing all ClinVar variants across the protein. Search a specific variant to highlight its position.

Clinical Trials

Active and recruiting trials from ClinicalTrials.gov

Batten DiseaseCLN6

Natural History of Neuronal Ceroid Lipofuscinosis, Batten's CLN6 Diseae

ACTIVE NOT RECRUITING
NCT03285425Emily de los ReyesStarted 2017-01
Natural history
Neuronal Ceroid Lipofuscinosis Type 2

A First-in-Human, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of Gene Therapy With TTX-381 for the Ocular Manifestations Associated With Neuronal Ceroid Lipofuscinosis Type 2 (CLN2) Disease

RECRUITING
NCT05791864Phase PHASE1, PHASE2Tern Therapeutics, LLCStarted 2023-05-17
TTX-381
CLN7

Study for the Treatment for CLN7 Disease

ACTIVE NOT RECRUITING
NCT04737460Phase PHASE1Benjamin GreenbergStarted 2021-05-04
AAV9/CLN7
CLN6Batten Disease

Long-Term Follow Up of CLN6 Batten Disease Subjects Following Gene Transfer

ACTIVE NOT RECRUITING
NCT04273243Emily de los ReyesStarted 2020-01-24
AT-GTX-501
Neuronal Ceroid LipofuscinosisBatten DiseaseCLN1 Disease

Natural History and Longitudinal Clinical Assessments in NCL / Batten Disease, the International DEM-CHILD Database

RECRUITING
NCT04613089Universitätsklinikum Hamburg-EppendorfStarted 2020-04-08
Natural History
Rare DisordersUndiagnosed DisordersDisorders of Unknown Prevalence

Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford

RECRUITING
NCT01793168Sanford HealthStarted 2010-07
Batten DiseaseCLN2Neuronal Ceroid-Lipofuscinoses

Examining Developmental Outcomes of Children Diagnosed With CLN2 Disease

ENROLLING BY INVITATION
NCT03862274Jessica ScherrStarted 2018-12-01
CLN2 Treatment
CLN3Batten Disease

Gene Therapy for Children With CLN3 Batten Disease

ACTIVE NOT RECRUITING
NCT03770572Phase PHASE1, PHASE2Neela TherapeuticsStarted 2018-11-13
Low dose CLN-301High dose CLN-301
CLN6Batten DiseaseBatten's Disease

Gene Therapy Trial for CLN6 Batten Disease

NOT YET RECRUITING
NCT07582484Phase PHASE1, PHASE2The Charlotte and Gwenyth Gray FoundationStarted 2026-08
scAAV9.CB.CLN6 (dose: 1.5E14 vector genomes)
Eye Diseases HereditaryRetinal DiseaseAchromatopsia

Inherited Retinal Degenerative Disease Registry

RECRUITING
NCT02435940Foundation Fighting BlindnessStarted 2014-06
Neuronal Ceroid Lipofuscinosis CLN5

Gene Therapy Study for Children With CLN5 Batten Disease

ACTIVE NOT RECRUITING
NCT05228145Phase PHASE1, PHASE2Neurogene Inc.Started 2022-01-31
NGN-101