A Double-Blind, Randomized, Placebo-Controlled Phase II Clinical Trial to Evaluate the Safety and Efficacy of L2-01 in Subjects With Crohn's Disease

Launched by L2 BIO, LLC · May 30, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment called L2-01 for people with Crohn's Disease, a condition that causes inflammation in the digestive tract. The goal of the study is to see if L2-01, which is made from special cells taken from the patient or their close relative's body fat, is safe to use and if it can help improve symptoms of Crohn's Disease. Participants will receive either L2-01 or a placebo (a substance with no active ingredients) to compare how well each option works in reducing inflammation and improving quality of life.

To be eligible for the trial, participants must be at least 18 years old and have been diagnosed with Crohn's Disease within the last year, but their disease should not be currently active. They should also meet a few other health criteria and be able to follow the study's requirements. If chosen to participate, individuals can expect to receive a single infusion of L2-01 and will be monitored closely for safety and effectiveness. This trial is not yet recruiting participants, but it represents an important step towards finding new treatments for Crohn's Disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with Crohn Disease (CD) diagnosed within 12 months before acceptance of clinical, endoscopical, anatomopathological and/or radiological criteria and have a non-active CD. (Crohn´s Disease Activity Index (CDAI)≤ 200)
• • 2. Any gender, \> 18 Years of age
• • 3. Negative pregnancy test in female subjects
• • 4. Patients voluntarily sign the informed consent before performance of any study-related procedures
• • 5. Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements
• Exclusion Criteria:
• • 1. Patients who have received infliximab or any other anti-TNF agent within 8 weeks before the cell treatment administration.
• • 2. Patients who have received tacrolimus or cyclosporine within 4 weeks before cell treatment.
• • 3. Patients with a history of alcohol or other addictive substance abuse within 6 months before inclusion.
• • 4. Severe uncontrolled diseases (chronic renal failure, cardio, pulmonary, etc.).
• • 5. Any type of medical or psychiatric disease which are considered an exclusion criterion, in the investigator's opinion.
• • 6. Patients with a diagnosis of malignant neoplasia, except basal cell or epidermoid carcinoma of the skin, or a previous history of malignant tumors, except those that have no evidence of relapse for at least 5 years.
• • 7. Subjects with congenital or acquired immunodeficiency.
• • 8. Subjects who tested positive for HIV 1/2, HBV, HCV, HTLV I/II, WNV, and syphilis
• • 9. Flu symptoms
• • 10. Patient had major surgery or serious trauma within 6 weeks before enrolment.
• • 11. Pregnant or breastfeeding women.
• • 12. Physical or psychological impossibility of following the protocol requirements
• • 13. Patients who are receiving or have received another investigational drug within 30 days prior to the first visit.