assignment
Recruiting

Safety and Preliminary Efficacy of CTX112 in Adults with Relapsed or Refractory Hematologic Autoimmune Disease

Trial ID
2025-523845-90-00
Protocol
CRSP-AID-501

Trial statistics

location_city
11
research sites
public
3
countries
medical_information
2
diseases
person_search
10
investigators

Objectives

The primary objective of this study is to evaluate the safety and preliminary efficacy of CTX112 in adults diagnosed with relapsed/refractory hematologic autoimmune disease. Assessment of these parameters is critical to determine the tolerability and potential clinical benefit of the intervention in a patient population that has failed standard treatment regimens.

Participants

The study involves 15 participants diagnosed with relapsed/refractory hematologic autoimmune disease. The study population consists of patients, including both males and females, within the 3 to 17 years of age range. The sponsor did not provide additional information regarding lifestyle considerations or specific selection methodologies.

Plans and Procedures

This Phase 3 clinical trial is designed to evaluate the safety and preliminary efficacy of CTX112 in adult participants diagnosed with relapsed/refractory hematologic autoimmune disease. The research methodology utilizes a controlled study design. The sequence of study procedures begins with a screening visit to determine eligibility. Following screening, participants proceed through scheduled follow-up visits to monitor clinical outcomes and safety parameters. The protocol concludes with an end-of-study visit. The total duration of the study is projected to extend from July 2026 through December 2030. Early termination from the study may occur based on predefined clinical conditions or safety protocols.

Treatment

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Efficacy

Efficacy assessment in this Phase 3 clinical trial focuses on the management of relapsed/refractory hematologic autoimmune disease. The evaluation of therapeutic effectiveness will be determined through predefined clinical endpoints designed to measure disease response and stability.

Trial Status by Country

Country Status Start of Recruitment Planned Patients
France FranceNot Yet Recruiting31 Jul 202610
Germany GermanyRecruiting31 Jul 202630
Spain SpainRecruiting31 Jul 202615

Sites & Investigators

Conditions Studied in This Trial