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CAR T-cell Therapy

NeoTCR-P1 adoptive cell therapy for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by PACT Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This study is evaluating whether a type of white blood cell called T-cells may help treat solid tumors.

Eligible Conditions
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of manufacturing NeoTCR-P1
Incidence of adverse events as defined as DLTs
Maximum Tolerated Dose (MTD) of NeoTCR-P1
+1 more
Secondary outcome measures
Area-under-the-concentration-vs-time-curve (AUC) in the peripheral blood
Duration of Response mediated by neoTCR-P1 administered as a single agent or in combination with nivolumab to participants with solid tumors
Maximum concentration of NeoTCR-P1 (Cmax) in the peripheral blood
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: NeoTCR-P1 plus nivolumabExperimental Treatment2 Interventions
Single dose of NeoTCR-P1 plus nivolumab 480mg IV every four weeks for up to 6 doses.
Group II: NeoTCR-P1 plus IL-2Experimental Treatment2 Interventions
Single dose of NeoTCR-P1 plus IL-2 500,000 IU/m2 SC twice daily (BID) for 7 days.
Group III: NeoTCR-P1Experimental Treatment1 Intervention
Single dose of NeoTCR-P1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nivolumab
2016
Completed Phase 3
~4960
IL-2
2007
Completed Phase 4
~1180

Find a Location

Who is running the clinical trial?

PACT Pharma, Inc.Lead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Colorado
How old are they?
65+
What site did they apply to?
City of Hope
Northwestern University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Average response time
  • < 2 Days
Most responsive sites:
  1. Northwestern University Medical Center: < 48 hours
Recent research and studies
Cancer CellJournal
Fast Track to Personalized TCR T Cell Therapies
Levy, Pierre L., and Alena Gros. 2022. “Fast Track to Personalized TCR T Cell Therapies”. Cancer Cell. Elsevier BV. doi:10.1016/j.ccell.2022.04.013.
clinicaltrials.govStudy
A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors
2019. "A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03970382.
~4 spots leftby Apr 2025
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