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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02390297
Other study ID # CAL-INT-00
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 2015
Est. completion date October 2031

Study information

Verified date February 2023
Source Calimmune, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Long term safety follow-up of Cal-1 recipients


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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 11
Est. completion date October 2031
Est. primary completion date October 2031
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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


Related Conditions & MeSH terms

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

Intervention

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

Locations

Country Name City State
United States UCLA CARE Center Los Angeles California
United States Quest Clinical Research San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Calimmune, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Detection of delayed clinical or molecular adverse events related to Cal-1, or the associated delivery procedures 15 years
Secondary 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
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