CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 9 enrolled
Drug / intervention
Autologous CD4 T-Cellsbiological
Likely dose
0.8-1.0 × 10^9 transduced CD4+ T-cells at dose level 1 (with potential escalation to higher dose levels); single infusionAI-extracted
Key inclusion· 11
  • ✓Documented HIV-1 infection confirmed by licensed Western blot or second antibody test
  • ✓Age ≥18 years
  • ✓Clinically stable on first or second HAART regimen with no changes within 4 weeks of enrollment
  • ✓Screening HIV-1 RNA ≤50 copies/mL within 30 days prior to enrollment
Key exclusion· 13
  • ✕Acute or chronic hepatitis B or hepatitis C infection
  • ✕Current or prior AIDS diagnosis
  • ✕History of cancer or malignancy (except successfully treated basal/squamous cell skin carcinoma)
  • ✕History or features of active or unstable cardiac disease or hemodynamic instability (though physician approval may allow history of cardiac disease)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03020524
NCT03020524Early Ph 1Completed
CompareCT.gov

A Pilot Study to Evaluate the Safety and Tolerability of Escalating Doses of Autologous CD4 T-Cells Modified With Lentiviral Vector Expressing an HR2, C34-peptide Conjugated to the CXCR4 N-terminus in HIV-infected Subjects

University of Pennsylvania·interventional·Posted Jan 13, 2017·Updated Nov 15, 2022

In Brief

A Early Phase 1 clinical trial evaluating Autologous CD4 T-Cells for Hiv. Completed, enrolled 9 participants across 1 site.

Detailed Summary

A single cohort, open-label pilot study of the safety and tolerability of a single infusion of autologous CD4+ T-cells genetically modified with an HR2, C34-peptide conjugated to the CXCR4 N-terminus using a lentiviral vector in HIV-infected subjects. This is a first in human study of C34-CXCR4 T cells

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHiv
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 13, 2017
Enrollment StartJan 1, 2017
Primary CompletionNov 1, 2019
Study CompletionMar 1, 2020
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 9.5 years ago

Interventions

Autologous CD4 T-Cellsbiological

all participants will receive a single infusion of C34-CXCR4-modified CD4+ T-cells at one of 3 dose levels. The first 3 subjects will receive dose level 1 of 0.8-1x109 transduced CD4+T-cells. Provided no dose limiting toxicity (DLT) is seen at the first dose level, the next 3 subjects will receive infusion at the 2nd dose level of 2.4-3x109 transduced CD4+ T-cells. If no DLT occurs at that dose, the final 3 subjects will receive the 3rd dose level of 0.8-1x1010 transduced CD4+ T-cells. In the event of a DLT (grade 3 or higher unexpected, related AE) recruitment will be paused pending DSMB decision