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

February 7, 2023 updated by: Calimmune, Inc.

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

Long term safety follow-up of Cal-1 recipients

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90035
        • UCLA CARE Center
      • San Francisco, California, United States, 94115
        • Quest Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Eligibility for this protocol is dependent on prior exposure to a Cal-1 modified hematopoietic cellular product. The study population will thus consist of individuals with HIV-1 infection, who have met criteria for participation in a Cal-1 phase I/II clinical trial and received a dose of Cal-1 modified hematopoietic cells as part of a previous study

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single
Collection of blood samples for general health (complete blood count) and Cal-1 specific analyses
Genetic: Blood tests
Collection of blood samples for general health (complete blood count) and Cal-1 specific analyses

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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
Time Frame: 15 yars
15 yars

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Calimmune, Inc.

Investigators

  • Principal Investigator: Ronald Mitsuyasu, MD, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2015

Primary Completion (ANTICIPATED)

October 1, 2031

Study Completion (ANTICIPATED)

October 1, 2031

Study Registration Dates

First Submitted

March 11, 2015

First Submitted That Met QC Criteria

March 11, 2015

First Posted (ESTIMATE)

March 17, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CAL-INT-00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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