NCT02390297

Brief Summary

Long term safety follow-up of Cal-1 recipients

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
66mo left

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Apr 2015Oct 2031

First Submitted

Initial submission to the registry

March 11, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
15 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
16.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2031

Last Updated

October 10, 2025

Status Verified

October 1, 2025

Enrollment Period

16.5 years

First QC Date

March 11, 2015

Last Update Submit

October 9, 2025

Conditions

HIV-1 InfectionReceipt of Cal-1 Modified Hematopoietic Cellular Products

Outcome Measures

Primary Outcomes (1)

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

    15 years

Secondary Outcomes (1)

  • 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

Study Arms (1)

Single

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

Genetic: Blood tests

Interventions

Blood testsGENETIC

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

Single

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • Inability to understand and provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCLA CARE Center

Los Angeles, California, 90035, United States

Location

Quest Clinical Research

San Francisco, California, 94115, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cryopreserved white blood cells and DNA and RNA extracted from peripheral blood

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Raphael Landovitz, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2015

First Posted

March 17, 2015

Study Start

April 1, 2015

Primary Completion (Estimated)

October 1, 2031

Study Completion (Estimated)

October 1, 2031

Last Updated

October 10, 2025

Record last verified: 2025-10

Locations

US(2)