NCT06671236 Clinical Study of Regulatory T Cells (Tregs) in the Treatment of Neurodegenerative Diseases
| NCT ID | NCT06671236 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Novabio Therapeutics |
| Condition | Amyotrophic Lateral Sclerosis (ALS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2024-11-21 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2024-11-21 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
An open, multi- center phase Ⅰ clinical study evaluating the safety and efficacy of autologous human polyclonal regulatory T cell injection (NP001 cell injection) in patients with Neurodegenerative diseases (ALS).
Eligibility Criteria
Inclusion Criteria: \- Patients must meet all of the following criteria to be eligible for enrollment in this study: 1. Male or female patients aged 18 to 70 years; 2. According to current international diagnostic criteria: ALS: defined by the Gold Coast Diagnostic Criteria (Shefner, 2020) as having a diagnosis of sporadic or familial amyotrophic lateral sclerosis (ALS), diagnosed as a probable, probable, or definite patient with laboratory support according to the World Federation of Neurology El Escorial criteria; 3. If there is a stable dose for more than one month prior to study entry. For example, patients with ALS can continue treatment with riluzole (Rilutek®) and/or edaravone (Radicava®); 4. Patients must have \> two weeks after the end of major surgery and after the completion of participation in other research trials; 5. Patients must have recovered from clinical toxicity (CTCAE \[5th Edition\] toxicity values have resolved to \< 2); 6. Serum creatinine less than or equal to 2.0 mg/dL; 7. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x upper limit of normal; 8. Bilirubin \< 1.5 (except Gilbert's disease); 9. Lung slow vital capacity (SVC) \> 70% of predicted normal; 10. No history of abnormal bleeding tendency; 11. Informed consent must be obtained prior to performing any study-related procedures that are not part of standard medical care, with the understanding that the participant may withdraw from the study without influence for the future medical care. Exclusion Criteria: \- Subjects with any of the following cannot be enrolled in this study: 1. uncontrolled infection; 2. \< 3 drugs do not adequately control hypertension; 3. Documented history of pulmonary embolism within 6 months of enrollment; 4. Clinically significant cardiology, defined as: myocardial infarction, NYHA-graded class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmia, or ECG evidence of acute ischemia or abnormal conduction system within 6 months prior to enrollment; 5. Patients with a history of coronary artery bypass grafting or angioplasty will be evaluated by cardiology and considered on a case-by-case basis; 6. Seropositive for HIV, hepatitis B or hepatitis C; 7. Pregnant or lactating patients; 8. Patients of childbearing potential or males with partners of childbearing potential who are unwilling to use contraception; 9. Participation in any other interventional study; 10. Treatment with another investigational drug, biologic, or device within 30 days or 5 half-lives (whichever is longer) of the screening period. Patient participation in observational/non-interventional clinical studies will be discussed with the Medical Monitor; 11. Prior treatment with ALS gene or cell therapy; 12. History of clinically significant tumor, liver or kidney disease, or other uncontrolled disease; 13. presence of a feeding tube; 14. Current use of antipsychotics, antiepileptic drugs (except benzodiazepines, gabapentin, pre-Bahrain) or class 1 (e.g., flecainide) or class 3 (e.g., amiodarone) antiarrhythmic drugs; 15. Subjects who, in the opinion of the investigator, are at significant risk of suicide; 16. Other conditions that the investigator considers unsuitable for enrollment.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06671236 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Amyotrophic Lateral Sclerosis (ALS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06671236 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06671236 currently recruiting?
Yes, NCT06671236 is actively recruiting participants. Contact the research team at lumingqi@novabiotx.com for enrollment information.
Where is the NCT06671236 trial being conducted?
This trial is being conducted at Zhengzhou, China.
Who is sponsoring the NCT06671236 clinical trial?
NCT06671236 is sponsored by Novabio Therapeutics. The trial plans to enroll 12 participants.
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