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CAR T-cell Therapy

CD30 CAR T-Cell Therapy for Lymphoma

Phase 2

Recruiting

Led By Anne Beaven, MD

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Subjects relapsed after allogeneic stem cell transplantation are eligible provided the patient is ≥180 days from transplant, not on immunosuppresive therapy to treat/prevent graft-versus-host disease and has no evidence of active graft-versus-host disease.

Karnofsky score of >60%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

Study Summary

This trial is testing a new treatment for lymphoma that involves modifying a patient's T cells so that they will attack the cancer. There are risks associated with the treatment and with the study procedures, but the hope is that this will be an effective treatment for those who have relapsed or are refractory to other treatments.

Who is the study for?

This trial is for adults over 18 with CD30+ peripheral T-cell lymphoma who've had at least two prior treatments, or relapsed within a year after therapy or transplant. Candidates must have a Karnofsky score above 60%, indicating they can care for themselves. Pregnant women and those with active infections like HIV or hepatitis are excluded.Check my eligibility

What is being tested?

The study tests ATLCAR.CD30 T cells, which are the patient's own immune cells modified to target lymphoma cancer cells. Participants will undergo chemotherapy (Fludarabine, Cyclophosphamide, Bendamustine) before receiving these engineered T cells. Some may get a second infusion if they respond well and there are extra modified cells available.See study design

What are the potential side effects?

Risks include infection, fever, nausea, vomiting, neurotoxicity (nerve damage symptoms), and cytokine release syndrome which might cause low blood pressure or breathing difficulties. Procedures like biopsies could also pose risks such as bleeding or pain.

Eligibility Criteria

Inclusion Criteria

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

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I had a stem cell transplant over 6 months ago, am not on immunosuppressants, and don't have graft-versus-host disease.

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I am mostly able to care for myself but may need occasional help.

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I am 18 years old or older.

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My condition worsened after a stem cell transplant using my own cells.

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My lymphoma is CD30+ as confirmed by tests.

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My latest biopsy shows CD30+ disease after my last anti-CD30 treatment.

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I have undergone at least two treatments for my lymphoma.

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I had a relapse after my stem cell transplant.

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My lymphoma did not respond or came back within a year after treatment.

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My condition worsened after a stem cell transplant from a donor.

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I am 18 years old or older.

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

Progression free survival (PFS) after administration of the ATLCAR.CD30 in subjects with relapsed/refractory CD30+ peripheral T cell lymphoma

Secondary outcome measures

Best overall response rate (BOR) mediated by the ATLCAR.CD30 product administered in subjects with relapsed/refractory CD30+ peripheral T cell lymphoma

Antigens, CD30

Incidence of Dose Limiting Toxicity (DLT) (safety and tolerability) when administering two sequential infusions of the ATLCAR.CD30 product in subjects with relapsed/refractory CD30+ peripheral T cell lymphoma

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: ATLCAR.CD30 cellsExperimental Treatment4 Interventions

The cellular product consisting of ATLCAR.CD30 cells will be administered via intravenous injection over 5 - 10 minutes through either a peripheral or a central line. The volume of infusion will depend upon the concentration of the cells when frozen and the size of the subject. Administration to eligible subjects will occur within 2 - 14 days after completing the lymphodepleting chemotherapy regimen

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine

2012

Completed Phase 3

~1100

Bendamustine

2015

Completed Phase 3

~2950

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor

351 Previous Clinical Trials

88,313 Total Patients Enrolled

Anne Beaven, MDPrincipal InvestigatorUNC Chapel Hill

4 Previous Clinical Trials

45 Total Patients Enrolled

Media Library

ATLCAR.CD30 T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04083495 — Phase 2

Peripheral T-Cell Lymphoma Research Study Groups: ATLCAR.CD30 cells

Peripheral T-Cell Lymphoma Clinical Trial 2023: ATLCAR.CD30 T cells Highlights & Side Effects. Trial Name: NCT04083495 — Phase 2

ATLCAR.CD30 T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04083495 — Phase 2

Frequently Asked Questions

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

Does this research encompass adults aged 60 and over?

"This medical study is accepting candidates who are of legal age and younger than 99."

Answered by AI

Are more patients needed for this investigation?

"Per the clinicaltrials.gov database, this trial is still recruiting patients; it was initially advertised on September 17th 2019 and had its information most recently updated on March 4th 2022."

Answered by AI

What are the eligibility criteria for participation in this clinical experiment?

"This clinical trial requires 20 individuals, aged between 18 and 99 with a diagnosis of T-Cell Lymphoma. To be eligible for participation, participants must consent to the written informed consent and HIPAA authorization release of private medical information, have Karnofsky score higher than 60%, possess histological or cytological evidence/confirmation that their lymphoma is CD30+, received at least two prior lines of therapy which included brentuximab vedotin unless ineligibility has been proven, relapsed after autologous stem cell transplantation if applicable within 180 days from allogeneic stem cell transplantation without active signs of"

Answered by AI

Is ATLCAR.CD30 T cells a secure option for individuals?

"Taking into account the fact that this is a Phase 2 trial, which implies there is evidence of safety but no proof of efficacy yet, our team at Power rated ATLCAR.CD30 T cells as having an overall safety score of 2."

Answered by AI

How many participants are being recruited for this research endeavor?

"Affirmative. Per clinicaltrials.gov's records, this research endeavour was initially posted on September 17th 2019 and is currently recruiting participants. Only 20 patients are needed to be enrolled from two different medical facilities."

Answered by AI

Are there any precedents of utilizing ATLCAR.CD30 T cells in prior clinical experiments?

"Currently, 946 medical trials related to ATLCAR.CD30 T cells are underway worldwide; 176 of these studies have entered Phase 3 and the majority originate from Philadelphia, Pennsylvania. In total, there are 32473 unique clinical sites running such tests."

Answered by AI

What maladies is ATLCAR.CD30 T cell therapy typically employed for?

"ATLCAR.CD30 T cells is a medical intervention that can assist those with multiple sclerosis and other ailments like leukemia, myelocytic, acute, retinoblastoma and multiple myeloma."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CD30 CAR for Relapsed/Refractory CD30+ T Cell Lymphoma

2019. "CD30 CAR for Relapsed/Refractory CD30+ T Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04083495.

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