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WT-gag-TCR modified T cells

Phase 1

HIV Infections | Monoclonal antibody | Infectious Disease |Adaptimmune Therapeutics PLC Sponsored ADR|Last Updated: Oct 10, 2019

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment2

FDA Designations

No designations recorded

Clinical trial landscape

WT-gag-TCR modified T cells · 1 trial · 1 indication

Phase 1 1
NCT00991224Redirected High Affinity Gag-Specific Autologous T Cells for HIV Gene TherapyHIV Infections
COMPLETED2 Analytics
PHASE1COMPLETED
Redirected High Affinity Gag-Specific Autologous T Cells for HIV Gene Therapy
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine optimal dose and to evaluate the safety and tolerability of the study drug.
3 years from end of study
To monitor for delayed adverse events associated with lentiviral vector gene transfer (RCL and insertional oncogenesis)
3 years from end of study

Secondary Endpoints

To determine the antiviral effects of WT-gag-and α/6-gag- TCR transduced cells in patients with low and high antigen load (presence and absence of viremia)
3 years from end of study
To monitor engraftment of vector modified cells in the peripheral circulation
3 years from end of study
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelFACTORIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTALSubjects who are HIV positive, taking medication to control virus, have an undetectable viral load, CD4 count greater than 450 at the time of enrollment, a CD4 nadir \>200 and a recorded historical viral load setpoint, will receive a WT-gag-TCR modified autologous T cells, followed one week later by a 16 week treatment interruption.
Arm 2EXPERIMENTALSubjects who are HIV positive, taking medication to control virus, have an undetectable viral load, CD4 count greater than 450 at the time of enrollment, a CD4 nadir \>200 and a recorded historical viral load setpoint, will receive a α/6-gag-TCR modified autologous T cells, followed one week later by a 16 week treatment interruption.
Arm 3EXPERIMENTALSubjects who are HIV positive, taking medication to control virus, have an undetectable viral load, CD4 count greater than 450 and a CD4 nadir \>200. Subject will undergo an 16 week treatment interruption during which a single infusion of WT-gag-TCR modified autologous T cells at 8 weeks post STI.
Arm 4EXPERIMENTALSubjects who are HIV positive, taking medication to control virus, have an undetectable viral load, CD4 count greater than 450 and a CD4 nadir of \>200. Subject will undergo a 16-week treatment interruption during which a single infusion of α/6-gag-TCR modified autologous T cells at 8 weeks post STI.

Interventions

NameTypeDescription
WT-gag-TCR modified T cellsBIOLOGICALSingle dose of WT-gag-TCR modified T cells infused over 3 consecutive days.
α/6-gag-TCR modified T cellsBIOLOGICALSingle dose of WT-gag-TCR modified T cells infused over 3 consecutive days.
STI or Drug HolidayOTHERSubjects will stop taking antiviral medications for 16 weeks.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Age 18 years or older * Karnofsky Performance of 80 or higher * HLA-A2 Positive * Chronic HIV-1 infection * On stable HAART regimen (with no changes within 4 weeks of study entry) * Willing to undergo a limited treatment interruption of antiretroviral medication * CD4+ T cell ...

Countries:United States
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Frequently asked questions about WT-gag-TCR modified T cells

What is WT-gag-TCR modified T cells used for?

WT-gag-TCR modified T cells is an investigational cell therapy being studied for the treatment of HIV infections. It is a monoclonal antibody modality currently in Phase 1 clinical development. The therapy is designed to target HIV through genetically modified T cells, though it remains investigational and is not yet approved.

What does WT-gag-TCR modified T cells target?

WT-gag-TCR modified T cells targets the HIV Gag protein. The therapy involves redirecting high-affinity Gag-specific autologous T cells to recognize and attack HIV-infected cells. This approach is being evaluated in a Phase 1 clinical trial for patients with HIV infections.

Who makes WT-gag-TCR modified T cells?

WT-gag-TCR modified T cells is being developed by Adaptimmune Therapeutics PLC, which trades under the ticker ADAP. The company is conducting clinical research on this investigational therapy for HIV infections, with the therapy currently in Phase 1 development.

What phase is WT-gag-TCR modified T cells in?

WT-gag-TCR modified T cells is in Phase 1 clinical development. It is an investigational therapy for HIV infections and has not been approved by regulatory authorities. The Phase 1 trial has been completed, with a total enrollment of 2 participants.

What clinical trials is WT-gag-TCR modified T cells in?

WT-gag-TCR modified T cells has one completed Phase 1 clinical trial, identified as NCT00991224, titled 'Redirected High Affinity Gag-Specific Autologous T Cells for HIV Gene Therapy.' The trial enrolled 2 participants with HIV infections in the United States and was a controlled, non-randomized study.

Is WT-gag-TCR modified T cells the same as redirected high affinity Gag-specific autologous T cells?

Yes, WT-gag-TCR modified T cells is the same as redirected high affinity Gag-specific autologous T cells. The clinical trial NCT00991224 uses this description to refer to the therapy, which involves genetically modified T cells targeting the HIV Gag protein for the treatment of HIV infections.