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Clinical trial

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

ID
Name
CAL-INT-00
Description
Long term safety follow-up of Cal-1 recipients
Trial arms
Trial start
2015-04-01
Estimated PCD
2031-10-01
Trial end
2031-10-01
Status
Active (not recruiting)
Treatment
Blood tests
Collection of blood samples for general health (complete blood count) and Cal-1 specific analyses
Arms:
Single
Size
11
Primary endpoint
Detection of delayed clinical or molecular adverse events related to Cal-1, or the associated delivery procedures
15 years
Eligibility criteria
Inclusion Criteria: * Signed informed consent * Previous treatment with the Cal-1 modified hematopoietic cellular products Exclusion Criteria: * Inability to understand and provide informed consent
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Cryopreserved white blood cells and DNA and RNA extracted from peripheral blood'}, 'enrollmentInfo': {'count': 11, 'type': 'ACTUAL'}}
Updated at
2023-02-08

1 organization

1 product

2 indications

Product
Blood tests
Indication
HIV-1 Infection
Indication
Cal-1 Modified Hematopoietic Cellular Products
Organization
Calimmune