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An early-stage clinical trial evaluating CK0803, <a href="https://cellenkosinc.com/">Cellenkos</a>&#8216; regulatory T-cell-based therapy for people with <a href="https://alsnewstoday.com/what-is-als/">amyotrophic lateral sclerosis</a> (ALS), has completed dosing its first patient group, the company announced in a <a href="https://www.prnewswire.com/news-releases/michael-e-debakey-va-medical-center-va-hospital-announces-new-cell-therapy-clinical-trial-for-amyotrophic-lateral-sclerosis-302039441.html">press release</a>.
The six patients, all adults, were treated at the Columbia University Irving Medical Center, in New York City, in the Phase 1 run-in period of the <a href="https://clinicaltrials.gov/ct2/show/NCT05695521">REGALS Phase 1/1b clinical trial (NCT05695521)</a>, which focused on safety. The trial now will enroll another 60 adults with ALS in its randomized Phase 1b part to continue to examine the treatment’s safety and efficacy.
The participants to date have been recruited at the single New York study site, but a U.S. Department of Veteran Affairs (VA) hospital in Houston has <a href="https://www.va.gov/houston-health-care/stories/new-hope-for-als-veterans/#:~:text=DeBakey%20VA%20Medical%20Center%20in,treatment%20for%20the%20neurodegenerative%20disease.">announced it will recruit 10 patients</a> for the clinical trial, slated to span about six months.
The Michael E. DeBakey Veteran Affairs Medical Center is the first and only VA hospital in the U.S. to join REGALS — and provide military veterans the opportunity to receive the cell-based therapy, which is designed to reduce neuroinflammation and balance the activity of the immune system.
&#8220;We are thrilled that our veterans will get the opportunity to receive such a cutting edge therapeutic that could be life altering,&#8221; said James Orengo, MD, PhD, principal investigator of the study at the DeBakey VA Medical Center.
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<h3>VA hospital &#8216;excited&#8217; to be among first sites to test novel therapy</h3>
&#8220;The incidence of ALS is elevated in veterans and novel therapies are desperately needed,&#8221; Orengo said.
Indeed, it&#8217;s estimated that more than 16% of all ALS patients are veterans, who are <a href="https://alsnewstoday.com/causes-of-als/">twice as likely to develop the disease</a> as are individuals in the general population.
Scientists have suggested that this increased prevalence likely is related to increased exposure to chemicals, strenuous physical conditions, and trauma during military service.
&#8220;We made a conscious decision to make this novel cell therapy available to the veterans and remain committed to provide our continued support to those who have served our country,&#8221; said Tara Sadeghi, Cellenkos&#8217; chief operating officer, noting that &#8220;there is an urgent need for novel treatments for all forms of ALS.&#8221;
Altogether, the REGALS trial will involve a total of 66 ALS patients with disease onset in the previous five years. All will receive the cell-based therapy through intravenous or into-the-vein infusions. The first four treatment doses are given weekly, followed by monthly infusions for the next five months.
[quote=&#8221;center&#8221;]We made a conscious decision to make this novel cell therapy available to the veterans and remain committed to provide our continued support to those who have served our country.[/quote]
In the <a href="https://alsnewstoday.com/news/patient-dosed-trial-potential-als-cell-based-therapy-ck0803/">Phase 1 part of the trial</a>, which is now complete, researchers assessed the treatment&#8217;s safety and efficacy. The main goals of the Phase 1b part are to determine the incidence and severity of side effects as well as changes in a combined assessment of function and survival.
Secondary efficacy measures include changes in the rate of disease progression, quality of life, lung function, and muscle strength.
For its part, the Houston VA clinic is &#8220;excited to be one of the first sites [to test this] novel T regulatory cells therapy for ALS,&#8221; Barbara W. Trautner, the center&#8217;s deputy associate chief of staff for clinical research, said in the VA announcement.
&#8220;We hope this is the first of many trials that we can open to develop new therapies for veterans with neurodegenerative disorders,” Trautner said, noting that the center&#8217;s neurologists &#8220;jumped at the chance to offer this to our veterans.&#8221;
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<h3>Cell-based therapy aims to reduce inflammation in ALS</h3>
People with ALS generally have high levels of inflammatory T-cells, which aid in the progressive dysfunction and death of motor neurons, the nerve cells that control voluntary movements. Conversely, immunosuppressive regulatory T-cells, known as Tregs, usually are found at lower levels than are normal in these patients, and are also less effective.
Tregs are immune cells that help suppress excessive inflammation and maintain the immune system&#8217;s healthy functioning. As such, they&#8217;re believed to help reduce some of the inflammation that causes damage in ALS.
CK0803 is a cell-based therapy that uses Tregs isolated from healthy umbilical cord blood, without the need to match patient and donor. These cells are then enriched and differentiated to target a given condition using the company&#8217;s proprietary <a href="https://cellenkosinc.com/ourscience/index.html">CRANE technology</a>.
The technology enables the production of several CK0803 doses from a single umbilical cord blood unit, and the final product can be frozen and stored for long periods — making treatments readily available for patients when needed.
“We are very excited to open this first cell therapy trial for ALS in the VA,” Orengo, also a professor of neurology at Baylor College of Medicine, in Houston, said in the Veteran Affairs announcement.
“We know that neuroinflammation fuels the ALS disease process. We believe that this new treatment, which involves calming the immune system in the central nervous system, holds great promise in halting this disease,” Orengo said.

Trial of cell-based therapy CK08031 finishes dosing 1st patient group

<a href="https://cellenkosinc.com/">Cellenkos</a> has dosed the first patient in the Phase 1/1b clinical trial that&#8217;s evaluating its regulatory T-cell-based therapy CK0803 for the treatment of <a href="https://alsnewstoday.com/what-is-als/">amyotrophic lateral sclerosis</a> (ALS).
The patient will be one of six participants included in the Phase 1 run-in period of the <a href="https://clinicaltrials.gov/ct2/show/NCT05695521">REGALS clinical trial (NCT05695521)</a>, which will examine the therapy&#8217;s safety and tolerability before an additional 60 patients are added to the randomized Phase 1b part.
&#8220;The dosing of the first patient marks an exciting milestone for our company. The initiation of this study of CK0803 is an important achievement that brings us closer to delivering a potential new treatment which may have a life-changing impact for ALS,&#8221; Tara Sadeghi, chief operating officer at Cellenkos, said in a <a href="https://www.prnewswire.com/news-releases/cellenkos-announces-first-patient-dosed-with-ck0803-cell-therapy-for-treatment-of-amyotrophic-lateral-sclerosis-301812682.html">press release</a>.
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Regulatory T-cells (Tregs) are immune cells that act as a so-called peacekeeper, helping to suppress excessive inflammatory responses, and contributing to maintain a healthy equilibrium of the immune system.
Previous studies have indicated that ALS patients have higher levels of inflammatory T-cells, but their Tregs are found at lower levels and also are less effective at dampening immune responses. This suggests that increasing Treg numbers and boosting their function may slow ALS disease progression and ease symptoms.
CK0803 is a donor-derived Treg-based treatment product that&#8217;s designed to travel preferentially to sites of inflammation in the central nervous system (the brain and spinal cord), where they can help to balance the immune response.
The cells in CK0803 are derived specifically from umbilical cord blood. This means it can be used as an off-the-shelf therapy in multiple patients without the need to match patients and donors.
<h3>CRANE technology</h3>
Cellenkos uses its proprietary <a href="https://cellenkosinc.com/ourscience">CRANE technology</a> to produce its Treg products, in which the collected cells are enriched and differentiated to become tailored to a treat a specific disease.
The technology also enables the production of multiple doses of CK0803 from a single umbilical cord blood unit. And the final product can be frozen and stored for long periods, being readily available for patients when needed in an outpatient setting.
&#8220;Promising data from six ALS patients previously treated with allogeneic cord blood Treg cells through an expanded access program at our Center supports the clinical development of CK0803,&#8221; said Neil Shneider, MD, PhD, principal investigator for the CK0803 clinical study.
”We are grateful to Cellenkos for their commitment to applying their technology to ALS,&#8221; added Shneider, who also is an associate professor of neurology and director of Columbia University&#8217;s Eleanor and Lou Gehrig ALS Center in New York.
The recently started clinical trial follows an <a href="https://alsnewstoday.com/news/fda-clears-als-clinical-study-cellenkos-treg-cell-therapy-ck0803/">approval</a> by the U.S. Food and Drug Administration allowing Cellenkos to begin clinical testing of CK0803 in ALS patients.
Participants will receive the investigational cell-based therapy via into-the-vein (intravenous) infusion. The first four infusions will be given weekly, and additional infusions will be administered monthly for the next five months.
<h3>Two trial phases</h3>
The initial run-in part of REGALS will assess the safety and tolerability of multiple doses of CK0803. Then the placebo-controlled Phase 1b trial step will continue to examine safety and establish some preliminary signs of efficacy.
That phase&#8217;s main goal is to assess CK0803&#8217;s effect on the combined assessment of function and survival, a combined measure of survival and disease progression. Secondary measures include changes in neurofilament light chain levels, a marker of nerve damage, in the blood and spinal fluid.
Top-line data is expected by May 2026 and the trial is estimated to end by late 2027.
“We believe that CK0803 has the potential to provide a much-needed treatment option for patients. We are enthusiastic to move forward with this trial and to further explore the potential of CK0803 in ALS and other neurodegenerative diseases,” Sadeghi said.

Tag: CK0803

Trial of cell-based therapy CK08031 finishes dosing 1st patient group

First ALS patient dosed in Cellenkos’ trial of CK0803