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CAR T-cell Therapy

CD30 CAR T-Cells for Lymphoma (CARCD30 Trial)

Phase 1

Waitlist Available

Led By Helen E Heslop, 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

Available autologous transduced EBV-specific cytotoxic T lymphocytes with 15% or more expression of CD30CAR determined by flow-cytometry.

CD30 positive tumor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

CARCD30 Trial Summary

This trial tests whether combining two ways of fighting disease--antibodies and T cells--can create a more effective way of fighting cancer.

Who is the study for?

This trial is for children and adults with relapsed CD30+ Hodgkin's or Non-Hodgkin's Lymphoma, or those who can't complete standard therapy. Participants must be EBV positive, not pregnant, willing to use effective birth control, have a certain level of blood oxygenation and organ function, and sign informed consent.Check my eligibility

What is being tested?

The study tests genetically modified T cells that target lymphoma by combining an anti-CD30 antibody with EBV-specific T cells. This aims to create long-lasting 'chimeric receptor' T cells capable of recognizing and killing lymphoma more effectively than previous treatments.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include immune reactions due to the introduction of modified T cells into the body, similar to other cell therapies which can cause fever, fatigue, headache, or allergic reactions.

CARCD30 Trial Eligibility Criteria

Inclusion Criteria

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

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My treatment involves a specific immune cell therapy with at least 15% CD30CAR expression.

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My tumor is CD30 positive.

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I have recovered from the side effects of my last chemotherapy, which was over a month ago.

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My cancer is CD30 positive.

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I can care for myself but may need occasional help.

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I am an adult with a disease that did not improve with standard treatments.

CARCD30 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 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

To evaluate the safety of escalating doses of autologous EBV-specific cytotoxic T-lymphocytes (CTLs)

Secondary outcome measures

To measure the anti-tumor effects of CAR.CD30 transduced CTLs

To measure the survival of CAR.CD30 transduced EBV-CTLs in vivo.

CARCD30 Trial Design

1Treatment groups

Experimental Treatment

Group I: autologous CAR.CD30 EBV specific-CTLsExperimental Treatment1 Intervention

Group One Dose (CTLs CAR.CD30) at Day 0: 2x10^7 cells/m2 Group Two Dose (CTLs CAR.CD30) at Day 0: 5x10^7 cells/m2 Group Three Dose (CTLs CAR.CD30) at Day 0: 1x10^8 cells/m2

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,162 Total Patients Enrolled

Center for Cell and Gene Therapy, Baylor College of MedicineOTHER

111 Previous Clinical Trials

2,799 Total Patients Enrolled

The Methodist Hospital Research InstituteOTHER

271 Previous Clinical Trials

80,357 Total Patients Enrolled

Media Library

autologous CAR.CD30 EBV specific-CTLs (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01192464 — Phase 1

Non-Hodgkin's Lymphoma Research Study Groups: autologous CAR.CD30 EBV specific-CTLs

Non-Hodgkin's Lymphoma Clinical Trial 2023: autologous CAR.CD30 EBV specific-CTLs Highlights & Side Effects. Trial Name: NCT01192464 — Phase 1

autologous CAR.CD30 EBV specific-CTLs (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01192464 — Phase 1

Frequently Asked Questions

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

What dangers have been identified in utilizing autologous CAR.CD30 EBV specific-CTLs therapeutically?

"The safety of autologous CAR.CD30 EBV specific-CTLs is rated as a 1, since this particular trial only has preliminary evidence in regards to its efficacy and potential dangers."

Answered by AI

Are new participants still eligible to join this research endeavor?

"Accurate. The information posted on clinicaltrials.gov states that this particular medical trial is not currently sourcing participants, as the last update was made in February 4th 2022. Nonetheless, there are 1784 other trials actively searching for candidates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

EBV CTLs Expressing CD30 Chimeric Receptors For CD 30+ Lymphoma

Helen Heslop 2011. "EBV CTLs Expressing CD30 Chimeric Receptors For CD 30+ Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01192464.

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