- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03773328
A Clinical Trial of CK0801 (a New Drug) In Patients With Treatment-Resistant Guillain-Barré Syndrome (GBS)
Phase I Trial To Evaluate The Safety Of CK0801 In Treatment-Resistant Guillain-Barré Syndrome (GBS)
Study Overview
Detailed Description
Study Type
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Tara Sadeghi
- Phone Number: 713-806-4787
- Email: tara.sadeghi@cellenkosinc.com
Study Contact Backup
- Name: Stacy Minor
- Phone Number: 800-217-8247
- Email: stacy.minor@cellenkosinc.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subject fulfills the diagnostic criteria for Guillain-Barré syndrome (GBS) (Appendix 1).
- HLA matched (≥ 3/6 at HLA-A, HLA-B, and HLA-DRB1) cord blood unit available for CK0801 generation.
- Subjects age 18 to 70 years.
- Subject has GBS disability scale score of 4 and unchanged 1 week after IVIG or PE treatment (Appendix 2).
- Subject has completed IVIG/PE treatment ≥ 4 weeks prior to CK0801 infusion.
- Subject has modified Erasmus GBS outcome score (mEGOS score) of ≥7 at the time of presentation and unchanged 1 week after IVIG or PE treatment (Table 3).
- Bilirubin ≤ 2 x ULN and, ALT ≤ 2 x ULN (unless Gilbert's syndrome).
- Calculated creatinine clearance of > 50mL/min using the Cockroft-Gault equation for adult patients 18 - 70 years old.
- Female subjects of child bearing potential (FPCP) must have a negative urine or serum pregnancy test. NOTE: FPCP is defined as premenopausal and not surgically sterilized. FPCP must agree to use maximally effective birth control or to abstain from heterosexual activity throughout the study. Effective contraceptive methods include intra-uterine device, oral and/or injectable hormonal; contraception, or 2 adequate barrier methods (e.g., cervical cap with spermicide, diaphragm with spermicide).
- Subject has agreed to abide by all protocol required procedures including study-related assessments, visits and long term follow up.
- Subject is willing and able to provide written informed consent. If subject is temporarily unable to sign the consent due to disease-related complications (e.g., upper extremity paralysis), a legally authorized representative (LAR) will be used. The subject will sign the consent as soon as they are capable.
Exclusion Criteria:
- Subject has received immunotherapy, chemotherapy, biologic or investigational agent within 4 weeks prior to CK0801 infusion.
- Subject has received prior CB Treg therapy.
- Subject has uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. The Protocol PI is the final arbiter of eligibility.
- Subject has received a vaccination with a Live virus (e.g., Measles, Mumps, Rubella, Varicella).
- Subject is pregnant or breastfeeding.
- HIV seropositivity
- Subjects who are unable to provide consent or who, in the opinion of the Investigator will be unlikely to fully comply with protocol requirements.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CK0801, 50ml
All subjects will receive adoptive therapy with an infusion of unrelated cord blood-derived regulatory T cells: CK0801. Subjects will receive one 50mL intravenous dose of CK0801 (Treg cells) on study Day 0. A total of three cohorts will be evaluated. Cohort dosing will be as follows: Dose level 1 = 1x10e6/kg Treg cells per kg recipient ideal body weight (IBW); Dose level 2 = 3x10e6/kg Treg cells per kg recipient ideal body weight (IBW); Dose level 3 = 1x10e7/kg Treg cells per kg recipient ideal body weight (IBW). |
CK0801 (Cord blood-derived T-regulatory cells)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Severe Infusion Toxicity as Assessed by CTCAE v4.0
Time Frame: 24 hours post-intervention
|
Number of Participants with Severe (Grade 3 or 4) Toxicity
|
24 hours post-intervention
|
Number of Participants with Severe Cytokine Release Syndrome (CRS)
Time Frame: 30 days post-intervention
|
Number of Participants with Severe (Grade 3 or 4) CRS
|
30 days post-intervention
|
Number of Participants with Regimen Related Death
Time Frame: 30 days post-intervention
|
• severe (grade 3 or 4) cytokine release syndrome (CRS) within 30 days
|
30 days post-intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Tara Sadeghi, Sponsor GmbH
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CK0801-201-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Guillain-Barré Syndrome
-
Hoffmann-La RocheChugai Pharmaceutical Co., Ltd. (Sponsor in Taiwan and Japan)Withdrawn
-
Annexon, Inc.International Centre for Diarrhoeal Disease Research, Bangladesh; ResearchPoint...CompletedGuillain-Barré SyndromeDenmark, Bangladesh
-
International Centre for Diarrhoeal Disease Research...Erasmus Medical Center; GBS-CIDP Foundation International; National Institute...CompletedGuillain-Barré SyndromeBangladesh
-
Nihon Pharmaceutical Co., LtdCompletedGuillain-Barré SyndromeJapan
-
Japan Blood Products OrganizationCompleted
-
National Taiwan University HospitalUnknownGuillain Barré SyndromeTaiwan
-
Centro de Reabilitacao do NorteAveiro UniversityRecruitingGuillain-Barré SyndromePortugal
-
Hansa Biopharma ABCompletedGuillain-Barré Syndrome (GBS)France, Netherlands, United Kingdom
-
University of VersaillesAssistance Publique - Hôpitaux de ParisCompletedAcute Respiratory Failure | Guillain Barré SyndromeFrance
-
Erasmus Medical CenterActive, not recruitingGuillain-Barré Syndrome | Miller Fisher SyndromeUnited States, Netherlands, United Kingdom, Bangladesh, Australia, Denmark, China, France, Germany, Spain, Argentina, Italy, Puerto Rico, South Africa, Belgium, Switzerland, Canada, Greece, Japan, Malaysia, Taiwan
Clinical Trials on CK0801
-
Cellenkos, Inc.Active, not recruitingBone Marrow DiseaseUnited States