CD6 targeted chimeric antigen receptors for treatment of certain autoimmune disorders

Inventors

Casemiro, Jose Enrique MonteroRoep, Bart OttoBrown, Christine E.

Assignees

City of Hope

Interested in licensing this patent?

MTEC can help explore whether this patent might be available for licensing for your application.

Publication Number

US-12281151-B2

Patent

Publication Date

2025-04-22

Expiration Date


Abstract

Provided herein are, inter alia, CD6 targeting CAR-T cell compositions and methods useful for treating autoimmune diseases (e.g., Type I diabetes).

Core Innovation

The disclosed invention relates to chimeric antigen receptor (CAR) constructs targeted to CD6. A CAR includes a single chain variable fragment targeted to CD6 comprising an amino acid sequence selected from SEQ ID NO: 38, 39, 40 and 41, together with a spacer comprising the amino acid sequence of SEQ ID NO: 91.

The CAR further includes a transmembrane domain selected from a CD4 transmembrane domain comprising the amino acid sequence of SEQ ID NO: 23, a CD8 transmembrane domain comprising the amino acid sequence of SEQ ID NO: 25, and a CD28 transmembrane domain comprising the amino acid sequence of SEQ ID NO: 7 or SEQ ID NO: 8. The CAR also includes a CTLA4 co-stimulatory domain comprising the amino acid sequence of SEQ ID NO: 17 and a CD3 zeta signaling domain comprising the amino acid sequence of SEQ ID NO: 92.

The disclosure contextualizes these CARs in regulatory T cell (Treg) formats and provides phenotype-marker options including CD4+CD25high, CD127low/negative, and CD6low/negative. The invention emphasizes therapeutic use in autoimmune diseases such as Type I diabetes, GvHD, and lupus, and describes CAR Tregs with CTLA4 signaling as outperforming in suppressing Teff proliferation.

Claims Coverage

The document includes two independent claims. Both independent claims cover CD6-targeted CARs with defined sequence-based modular components, and dependent claims further specify allowable sequence embodiments and regulatory T cell phenotype/marker constraints. Across the independent claims, there are five principal inventive features.

CD6-targeted CAR defined by scFv, spacer, transmembrane, CTLA4, and CD3 zeta sequences

A nucleic acid molecule encoding a chimeric antigen receptor (CAR) comprising a single chain variable fragment targeted to CD6 comprising an amino acid sequence selected from SEQ ID NO: 38, 39, 40 and 41; a spacer comprising the amino acid sequence of SEQ ID NO: 91; a transmembrane domain selected from the group consisting of a CD4 transmembrane domain comprising SEQ ID NO: 23, a CD8 transmembrane domain comprising SEQ ID NO: 25, and a CD28 transmembrane domain comprising SEQ ID NO: 7 or SEQ ID NO: 8; a CTLA4 co-stimulatory domain comprising SEQ ID NO: 17; and a CD3 zeta signaling domain comprising SEQ ID NO: 92.

CD6-targeted CAR defined by scFv, spacer, transmembrane, CTLA4, and CD3 zeta sequences

A chimeric antigen receptor (CAR) comprising a single chain variable fragment targeted to CD6 comprising an amino acid sequence selected from SEQ ID NO: 38, 39, 40 and 41; a spacer comprising the amino acid sequence of SEQ ID NO: 91; a transmembrane domain selected from the group consisting of a CD4 transmembrane domain comprising SEQ ID NO: 23, a CD8 transmembrane domain comprising SEQ ID NO: 25, and a CD28 transmembrane domain comprising SEQ ID NO: 7 or SEQ ID NO: 8; a CTLA4 co-stimulatory domain comprising SEQ ID NO: 17; and a CD3 zeta signaling domain comprising SEQ ID NO: 92.

Across the two independent claims, the coverage centers on CD6-targeted CARs and nucleic acid encoding such CARs built from explicitly identified sequence options for the CD6 single chain variable fragment, the spacer, one of specified CD4/CD8/CD28 transmembrane domains, a CTLA4 co-stimulatory domain, and a CD3 zeta signaling domain. Dependent claims further narrow permitted sequence embodiments and relate the CAR to regulatory T cell populations defined by marker-based phenotype proportions.

Stated Advantages

Inhibit pro-inflammatory CD6+ immune activity.

Avoid damage from beta-cell targeting.

Reduce activation.

Reduce cytokine release syndrome.

Reduce T-cell exhaustion.

Improve persistence/half-life.

CAR Tregs with CTLA4 signaling outperform in suppressing Teff proliferation.

Documented Applications

Treating autoimmune disease by administering engineered T lymphocytes/Tregs expressing the disclosed CD6-targeted CAR.

Autoimmune diseases, notably Type 1 diabetes.

Therapeutic use in autoimmune diseases, including Type I diabetes, GvHD, and lupus, using CD6 CARs in regulatory T cells with CTLA4 signaling.

JOIN OUR MAILING LIST

Stay Connected with MTEC

Keep up with active and upcoming solicitations, MTEC news and other valuable information.