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CAR T-cell Therapy

CAR T Cell Therapy for Lymphoma (RELY-30 Trial)

Phase 1
Recruiting
Led By Carlos A Ramos, 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
CD30-positive tumor as assayed in a CLIA certified pathology laboratory
PROCUREMENT: Diagnosis of relapsed/refractory HL or NHL
Must not have
Symptomatic cardiac disease (NYHA Class III or IV disease)
Tumor in a location where enlargement could cause airway obstruction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether it's more effective to give patients with lymphoma genetically modified T cells that have been combined with an antibody, after they've received chemotherapy to decrease the level of circulating T cells.

Who is the study for?
This trial is for individuals aged 16-75 with relapsed/refractory Hodgkin's or Non-Hodgkin's Lymphoma, whose tumors express CD30 and have T cells available for modification. Participants must understand the consent form, have a certain level of physical fitness (Karnofsky/Lansky score >60%), stable organ function, no significant heart arrhythmias, not be pregnant or breastfeeding, and agree to use effective birth control.
What is being tested?
The study tests genetically modified T cells called CD30.CAR T cells in patients who've had chemotherapy. These special T cells are designed to recognize and kill lymphoma cancer cells by targeting the CD30 molecule on their surface. The trial examines if these CAR T Cells can effectively fight cancer after reducing other circulating T cells through 'lymphodepletion' chemotherapy.
What are the potential side effects?
Potential side effects may include reactions related to the infusion of CAR T Cells such as fever, fatigue, headache; immune system responses that could affect normal organs; and complications from prior lymphodepleting chemotherapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor is CD30-positive.
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My Hodgkin's or non-Hodgkin's lymphoma has come back or did not respond to treatment.
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I am mostly able to care for myself but may need occasional help.
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My T cells show at least 15% CD30CAR expression.
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My lung function tests are at least half of what is expected for someone healthy.
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I agree to use effective birth control during and 6 months after the study. I understand and have signed the informed consent.
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My Hodgkin's or non-Hodgkin's lymphoma has returned or is not responding to treatment.
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My kidney function is good.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have severe heart disease that limits my daily activities.
Select...
My tumor is located where it could block my airway if it grows.
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I am currently taking high doses of steroids.
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My cancer has formed a large tumor or affects the area near my lungs.
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I am currently experiencing bleeding when I urinate.
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My cancer quickly worsened despite previous chemotherapy.
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I currently have an active infection.
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I currently have an active infection.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Patients with Dose-Limiting Toxicities (DLT)
Secondary study objectives
Mean Number of T cells transduced with the vector
T-Lymphocyte
Overall Response Rate

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: CD30.CAR T CellsExperimental Treatment1 Intervention
Each patient will receive one infusion of CAR modified T cells.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,024 Previous Clinical Trials
6,029,450 Total Patients Enrolled
The Methodist Hospital Research InstituteOTHER
285 Previous Clinical Trials
81,626 Total Patients Enrolled
Carlos A Ramos, MDPrincipal InvestigatorBaylor College of Medicine
5 Previous Clinical Trials
176 Total Patients Enrolled

Media Library

CD30 CAR T Cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02917083 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: CD30.CAR T Cells
Non-Hodgkin's Lymphoma Clinical Trial 2023: CD30 CAR T Cells Highlights & Side Effects. Trial Name: NCT02917083 — Phase 1
CD30 CAR T Cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02917083 — Phase 1
~9 spots leftby Apr 2026
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