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CAR T-cell Therapy

Treatment Phase for Hodgkin's Lymphoma

Phase 1

Waitlist Available

Led By Premal Lulla, MD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Recovered from all acute non-hematologic toxic effects of all prior chemotherapy

Diagnosis and clinical course falling into one of the following categories: Hodgkin lymphoma, Aggressive non-Hodgkin lymphoma, ALK-negative anaplastic T cell lymphoma or other peripheral T-cell lymphoma, ALK-positive anaplastic T cell lymphoma, CD30-positive tumor as assayed in a CLIA certified Pathology Laboratory

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying a new treatment for lymphoma, a type of cancer that has not responded well to previous treatments. The treatment involves combining antibodies and T cells, which are special white blood cells that

Who is the study for?

This trial is for patients with certain types of lymphoma, including diffuse large B cell, natural killer/T-cell, or classical Hodgkin lymphoma that has persisted or returned after treatment. Participants must meet specific health criteria not detailed here.Check my eligibility

What is being tested?

The study tests C7R.CD30.CAR-EBVST cells on patients with lymphoma. It aims to improve upon previous CAR T cell therapies by using a modified version that may have longer and stronger effects against cancer.See study design

What are the potential side effects?

While the side effects are not explicitly listed in the provided information, typical CAR T cell therapy side effects include fever, fatigue, immune reactions, and potential complications from targeting healthy cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have recovered from all major side effects of my previous chemotherapy.

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My diagnosis is one of the specified types of lymphoma or I have a CD30-positive tumor.

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I am between 12 and 75 years old.

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My kidney function is good.

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I can care for myself but may need occasional help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Dose limiting toxicity rate (DLT) by CTCAE 5.0

Secondary outcome measures

Duration of SD

Duration of response

Progression free survival (PFS)

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment PhaseExperimental Treatment1 Intervention

Four dose levels will be evaluated based on safety data from our current study of CD30 CAR T cells. Cohorts of three patients will be enrolled at each dose level The dose is based on the number of CD.30 CAR-EBVT-expressing cells administered. The total number of dose levels evaluated will depend upon toxicities experienced. Dose level cohorts will be numbered sequentially. Dose Level 1: 4 × 10^7 C7R.CD30.CAR-EBVST cells Dose Level 2: 1 × 10^8 C7R.CD30.CAR-EBVST cells Dose Level 3: 4 × 10^8 C7R.CD30.CAR-EBVST cells Dose Level 4: 8 × 10^8 C7R.CD30.CAR-EBVST cells

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteOTHER

275 Previous Clinical Trials

80,455 Total Patients Enrolled

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,322 Total Patients Enrolled

Center for Cell and Gene Therapy, Baylor College of MedicineOTHER

111 Previous Clinical Trials

2,727 Total Patients Enrolled

Frequently Asked Questions

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

Are patients currently able to participate in this ongoing medical study?

"Based on the details provided by clinicaltrials.gov, this particular study is not currently seeking participants. The trial was initially posted on June 1st, 2024 and last updated on December 11th, 2023. However, it's worth noting that there are currently 1821 other trials actively accepting candidates for participation."

Answered by AI

Is the inclusion criteria for this research study limited to individuals who are younger than 35 years old?

"To be considered eligible for this trial, applicants must fall within the age range of 12 to 75. It is worth noting that there are a total of 333 ongoing clinical trials specifically targeting individuals under the age of 18 and an additional 1648 studies focused on patients over the age of 65."

Answered by AI

Has the treatment phase received official endorsement from the FDA?

"Based on our assessment, the safety rating for the Treatment Phase is 1. This determination aligns with it being a Phase 1 trial, where there is limited data available to support both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Constitutive IL7R (C7R) Modified Banked Allogeneic CD30.CAR EBVSTS for CD30-Positive Lymphomas

Premal Lulla 2024. "Constitutive IL7R (C7R) Modified Banked Allogeneic CD30.CAR EBVSTS for CD30-Positive Lymphomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06176690.

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