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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%

Must not have

Positive for hepatitis B surface antigen or hepatitis B core antibody with positive viral load

Active infection with HIV, HTLV, HCV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active hepatitis B infection.

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I do not have an active infection with HIV, HTLV, or HCV.

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I am currently taking 10 mg or more of prednisone daily or its equivalent.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

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: 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

Bendamustine

2015

Completed Phase 3

~3230

Fludarabine

2012

Completed Phase 4

~1830