Long Term Follow up for the Detection of Delayed Adverse Events in Cal-1 Recipients

Active, not recruiting

• Conditions: Receipt of Cal-1 Modified Hematopoietic Cellular Products; HIV-1 Infection
• Interventions: Genetic: Blood tests

• Registration Number: NCT02390297
• Lead Sponsor: Calimmune, Inc.

Brief Summary

Long term safety follow-up of Cal-1 recipients

Detailed Description

Long Term Follow-up for the Detection of Delayed Adverse Events in Recipients of CD4+ T Lymphocytes and/or CD34+ Hematopoietic Stem/Progenitor Cells Transduced with LVsh5/C46 (Cal-1), a Dual Anti-HIV Gene Transfer Construct

Study Timeline

• Study First Submitted: 2015-03-11
• Study First Submitted QC: 2015-03-11
• Study First Posted: 2015-03-17
• Study Start: 2015-04
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12
• Primary Completion: 2031-10
• Study Completion: 2031-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Signed informed consent
• Previous treatment with the Cal-1 modified hematopoietic cellular products

Exclusion Criteria

• Inability to understand and provide informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single	Blood tests	Collection of blood samples for general health (complete blood count) and Cal-1 specific analyses

Primary Outcome Measures

Name	Time	Method
Detection of delayed clinical or molecular adverse events related to Cal-1, or the associated delivery procedures	15 years

Secondary Outcome Measures

Name	Time	Method
Assessment of the long term survival and activity of Cal-1 modified hematopoietic cells through evaluation of Cal-1 marking and expression in peripheral blood	15 yars

Trial Locations

Locations (2)

UCLA CARE Center; 🇺🇸 Los Angeles, California, United States

Quest Clinical Research; 🇺🇸 San Francisco, California, United States