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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02390297

Enrollment

Registered

2015-03-17

Start date

2015-04-30

Completion date

2031-10-31

Last updated

2025-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

GENETICBlood tests

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

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Inability to understand and provide informed consent

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026