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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

RELY-30 Trial 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.Check my eligibility

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.See study design

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.

RELY-30 Trial 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.

Select...

My Hodgkin's or non-Hodgkin's lymphoma has returned or is not responding to treatment.

Select...

My kidney function is good.

RELY-30 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

Number of Patients with Dose-Limiting Toxicities (DLT)

Secondary outcome measures

Mean Number of T cells transduced with the vector

T-Lymphocyte

Overall Response Rate

RELY-30 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.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,152 Total Patients Enrolled

The Methodist Hospital Research InstituteOTHER

272 Previous Clinical Trials

80,395 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

Frequently Asked Questions

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

Is this trial open to individuals who are beyond 45 years of age?

"The age restriction for this study is 12 years or older to 75 years and below."

Answered by AI

How many participants are presently involved in this research?

"Affirmative. Information provided on clinicaltrials.gov reveals that this trial, which was initially created on the 8th of May 2017 and updated most recently in July 2022, is actively looking for 66 volunteers from 2 sites."

Answered by AI

Are there currently any openings to take part in this research?

"Affirmative. As indicated by clinicaltrials.gov, this experiment is actively seeking participants having originally been uploaded on the 8th of May 2017 and last updated on 20th July 2022. Two sites are looking to recruit a total of 66 individuals in total."

Answered by AI

How secure are the applications of CAR T Cells for human use?

"CAR T cells have a safety rating of 1, as this trial is presently in Phase 1 and the efficacy and security has yet to be established."

Answered by AI

Could I qualitatively participate in this trial?

"This medical trial is enrolling 66 individuals between the ages of 12 and 75 who have lymphoma. The initial three patients in each dose level must be aged 16 to 75, however, if no dose-limiting toxicity occurs then participants as young as 12 can receive the same treatment. Additionally, hemoglobin levels need to be equal or greater than 7 (which may account for transfused values) and Karnofsky/Lansky score has to exceed 60%."

Answered by AI

Are there any other research projects that have explored the use of CAR T Cells?

"Currently, 889 clinical trials are researching the efficacy and safety of CAR T Cells with 161 studies at Phase 3. While most of these experiments can be found in Philadelphia, Pennsylvania, there is a total 28446 sites conducting research related to this cell type."

Answered by AI

What are CAR T Cells typically utilized to address?

"CAR T Cells has shown to be a powerful treatment for multiple sclerosis, as well as mixed-cell type lymphoma, leukemia, myelocytic acute and retinoblastomas."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Anti-cd30 CAR-T Cell Therapy in Relapsed and Refractory Hodgkin Lymphoma

Ramos, Carlos A., Natalie S. Grover, Anne W. Beaven, Premal D. Lulla, Meng-Fen Wu, Anastasia Ivanova, Tao Wang, et al.. 2020. “Anti-cd30 CAR-T Cell Therapy in Relapsed and Refractory Hodgkin Lymphoma”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.20.01342.

clinicaltrials.govStudy

CD30 CAR T Cells, Relapsed CD30 Expressing Lymphoma (RELY-30)

Carlos Ramos 2017. "CD30 CAR T Cells, Relapsed CD30 Expressing Lymphoma (RELY-30)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02917083.

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