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

Long term safety follow-up of Cal-1 recipients

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This study is active but is not currently recruiting participants.

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Key information

Conditions

HIV-1 Infection Receipt of Cal-1 Modified Hematopoietic Cellular Products

Sex eligibility

All sexes

Study type

Observational

Primary location

UCLA CARE Center, Los Angeles, California, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Inability to understand and provide informed consent

Treatment and study plan

Blood tests

Genetic

Collection of blood samples for general health (complete blood count) and Cal-1 specific analyses

Primary outcomes

Detection of delayed clinical or molecular adverse events related to Cal-1, or the associated delivery procedures

Time frame: 15 years

Secondary outcomes

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

Time frame: 15 yars

Sponsors and collaborators

Lead sponsor

Calimmune, Inc.

Industry

Registry information

Official study title

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, a Dual Anti-HIV Gene Transfer Construct

Important dates

Study start: 2015
Primary completion: 2031
Study completion: 2031
First posted: Mar 17, 2015
Registry last updated: Oct 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Active, Not Recruiting