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CAR T-cell Therapy

Cohort 1: TCRT-ESO-A2: 0.3 × 1010 TCRT-ESO-A2 cells * ±30% for Solid Tumors

Phase 1
Waitlist Available
Led By Carlos Becerra, MD
Research Sponsored by Athenex, 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 baseline to disease progression averaging one year
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new treatment called TCRT-ESO-A2, which uses a patient's own modified immune cells to fight advanced cancers. It targets patients with specific cancers that have limited treatment options. The modified cells are designed to better recognize and attack cancer cells. TCRT-ESO-A2 has shown promising results in previous studies.

Eligible Conditions
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to disease progression averaging one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to disease progression averaging one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose Escalation: Evaluate up to Eighteen Subjects With Tumors Expressing TCRT-ESO-A1 and Having Dose Limiting Toxicity Adverse Events as Assessed by CTCAE-Version 5
Secondary study objectives
Dose Escalation: Monitor Presence of Potentially Replication-Competent Lentivirus After TCRT ESO A2 Infusion
Dose Escalation: Monitor Presence of Potentially Replication-Competent Lentivirus before TCRT ESO A2 Infusion
Dose Escalation: Persistence of Genetically Modified T Cells in Vivo and Antigen Specific CD8 + Cytotoxic T lymphocytes
+27 more
Other study objectives
:Explore Persistence of Genetically Modified T cells in vivo.
Explore Association Between Maximum Dose Concentration Time and Disease Appropriate Circulating Tumor Marker CA-125
Explore Association Between Maximum TCRT ESO A2 Concentration time and Systemic Cytokine IFN-γ Level
+33 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: Cohort 3: TCRT-ESO-A2 : 3.0 × 1010 TCRT-ESO-A2 cells ±30%Experimental Treatment1 Intervention
Subjects will be evaluated for DLTs up to 28 days post-TCRT-ESO-A2 infusion. Enrollment into a dose level will be suspended if two of no more than six subjects at a dose level experience dose-limiting toxicity. Prior to increasing the dose, a cohort management meeting will be held after the final enrolled subject has been followed for up to28 days. The decision to increase to the next dose level will be a joint decision of the clinical site Investigators and Sponsor. At each cohort, there will be at least 7 days between infusion of each subject in the cohort.
Group II: Cohort 2: TCRT-ESO-A2: 1.0 × 1010 TCRT-ESO-A2 cells ±30%Experimental Treatment1 Intervention
Subjects will be evaluated for DLTs up to 28 days post-TCRT-ESO-A2 infusion. Enrollment into a dose level will be suspended if two of no more than six subjects at a dose level experience dose-limiting toxicity. Prior to increasing the dose, a cohort management meeting will be held after the final enrolled subject has been followed for up to28 days. The decision to increase to the next dose level will be a joint decision of the clinical site Investigators and Sponsor. At each cohort, there will be at least 7 days between infusion of each subject in the cohort. The decision to increase to the next dose level will be a joint decision of the clinical site Investigators and Sponsor.
Group III: Cohort 1: TCRT-ESO-A2: 0.3 × 1010 TCRT-ESO-A2 cells * ±30%Experimental Treatment1 Intervention
Subjects will be evaluated for DLTs up to 28 days post-TCRT-ESO-A2 infusion. Enrollment into a dose level will be suspended if two of no more than six subjects at a dose level experience dose-limiting toxicity. Prior to increasing the dose, a cohort management meeting will be held after the final enrolled subject has been followed for up to28 days. The decision to increase to the next dose level will be a joint decision of the clinical site Investigators and Sponsor. At each cohort, there will be at least 7 days between infusion of each subject in the cohort.

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Who is running the clinical trial?

Athenex, Inc.Lead Sponsor
26 Previous Clinical Trials
1,968 Total Patients Enrolled
Carlos Becerra, MDPrincipal InvestigatorBaylor University Medical Cancer Hospital
5 Previous Clinical Trials
93 Total Patients Enrolled
~0 spots leftby Nov 2025
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