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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
No Placebo-Only Group

Summary

This trial is testing a new treatment using specially modified immune cells called NeoTCR-P1 T cells. These cells are designed to find and destroy cancer cells in patients with solid tumors. The study aims to see if this treatment is safe and effective. These modified T cells have shown promise in treating cancers with unique mutations.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of manufacturing NeoTCR-P1
Incidence of adverse events as defined as DLTs
Maximum Tolerated Dose (MTD) of NeoTCR-P1
+1 more
Secondary study objectives
Duration of Response mediated by neoTCR-P1 administered as a single agent or in combination with nivolumab to participants with solid tumors
Objective Response Rate (ORR) in participants with solid tumors following infusion of NeoTCR-P1 as a single agent or in combination with nivolumab
Overall survival (OS) in participants with solid tumors following infusion of NeoTCR-P1 as a single agent or in combination with nivolumab
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~5250
IL-2
2007
Completed Phase 4
~1100

Find a Location

Who is running the clinical trial?

PACT Pharma, Inc.Lead Sponsor
~3 spots leftby Dec 2025
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