Latest FDA grants Fast Track designation to CK0803 in ALS

Cord blood regulatory T cell therapeutics

Cellenkos is a clinical-stage biotechnology company developing allogeneic, tissue-directed, cord blood-derived T-regulatory cell therapies to resolve inflammation in autoimmune, neurodegenerative and inflammatory diseases.

Explore the pipeline How Tregs work
FDA Fast Track · CK0803 · ALSPhase 2 cleared · CK0801 · Aplastic anemiaIND cleared · CK0802 · Steroid-refractory GVHDOrphan Drug · CK0804 · MyelofibrosisOrphan Drug · CK0803 · ALSOrphan Drug · CK0801 · Aplastic anemiaU.S. Patent US12472182B2
0Patients treated across Cellenkos clinical programs
0Dose-limiting toxicities observed across the Treg platform
0FDA designations: Fast Track and three Orphan Drug
0Product candidates spanning five therapeutic areas

Our science

Restoring the immune system's peacekeepers

Animated diagram of regulatory T cells, effector T cells and tissue Healthy tissue CK0801 Cord blood Tregs
01

Tregs protect the body from attack by T cells

Regulatory T cells (Tregs) suppress inflammation and keep T cells and other compartments of the immune system from attacking our own body.

02

Defective Tregs lead to autoimmune disease

Defective Tregs can no longer protect the body from the harmful effect of T cells, leading to autoimmune diseases including lupus, multiple sclerosis and rheumatoid arthritis, inflammatory disorders like Crohn's disease, and bone marrow failure syndromes like aplastic anemia.

03

A first-in-class, cord blood-derived Treg product

Clinically manufactured using Cellenkos' proprietary CRANE® platform from a single qualified umbilical cord blood unit, CK0801 shows superior T cell suppression and anti-inflammatory properties.

04

Infusion overcomes the existing Treg defect

CK0801 infusion replaces the defective Tregs and protects the body from T cell attack — releasing IL-10, consuming IL-2 that fuels aggressive T cells, and neutralizing antigen-presenting cells.

05

Restoring immune homeostasis

By preventing T cell attack against one's own body, CK0801 helps restore immune homeostasis — creating the conditions for disease control and tissue recovery.

The CRANE® platform

Tissue-directed Tregs that go where inflammation is

CRANE® generates disease-specific Treg products enriched for homing markers, so each candidate travels to the tissue driving disease. Select a program to trace its route.

Body map showing where each Treg product homes after IV infusion IV

CK0803

Neurotropic Tregs that cross into the CNS

Engineered to express high levels of CXCR3 and CD11a (LFA-1), CK0803 cells are designed to traffic across the blood-brain and blood-spinal cord barriers and migrate along CXCL10 gradients toward inflamed microglia.

Indication
Amyotrophic lateral sclerosis
Homing
CXCR3 / CXCL10 axis
Status
Phase 1/1b · FDA Fast Track
Cell therapy cleanroom with a scientist handling a cryopreserved cord blood product
  • Off-the-shelfCryopreserved product with a reported shelf life of nearly three years, ready for immediate use.
  • No matchingNo HLA or ABO matching required — derived from qualified U.S. public cord blood units (21 CFR Part 1271).
  • OutpatientPeripheral IV infusion without conditioning chemotherapy or IL-2 support.
  • Protected IPU.S. patent US12472182B2, granted November 18, 2025, covering compositions of regulatory T cells and methods of producing and using them.

Our pipeline

Six Treg programs across five therapeutic areas

Program Indication PreclinicalPhase 1Phase 2Phase 3

All product candidates are investigational and have not been approved by the FDA for any indication.

News center

Latest press releases

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Publications

Peer-reviewed clinical evidence

Cellenkos' clinical work has been published in NEJM Evidence and presented at the American Society of Hematology Annual Meeting.

  • 2025
    NEJM Evidence

    Off-the-shelf cord blood Treg therapy in ALS: clinical safety and preliminary efficacy under a compassionate-use regimen.

  • 2025
    ASH Annual Meeting · Abstract #5602

    Dose-intensive CK0804 regimen in JAK inhibitor-resistant or suboptimal myelofibrosis.

  • 2024
    NEJM Evidence

    Phase 1 study of CK0801 in bone marrow failure syndromes: no dose-limiting toxicities; 2 of 3 transfusion-dependent aplastic anemia patients achieved durable transfusion independence.

  • 2024
    ASH Annual Meeting · Oral presentation

    Phase 1b clinical data of CK0804 in myelofibrosis.

Fluorescent regulatory T cells under a microscope

Join our team

Build the next class of living medicines in Houston

We are growing our footprint in the Houston life sciences ecosystem. If you work in cell therapy manufacturing, clinical operations, translational science or quality, we would like to hear from you.

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Contact

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Address
5416 Chaucer Drive
Houston, TX 77005
Fax
(866) 277-0396
Media & investors
contact@cellenkosinc.com