RecruitingPhase 2NCT04083495

CD30 CAR for Relapsed/Refractory CD30+ T Cell Lymphoma

Phase II Study of the Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) for Relapsed/Refractory CD30+ Peripheral T Cell Lymphoma

Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

20 participants

Start Date

Sep 17, 2019

Study Type

INTERVENTIONAL

Conditions

Peripheral T Cell Lymphoma

Summary

This is a research study to determine the safety and tolerability of ATLCAR.CD30 for treating relapsed/refractory Peripheral T Cell Lymphoma. Blood samples will be collected from study participants and the immune T cells will be separated. T cells will be genetically modified in a laboratory at UNC-Chapel Hill to enable them to produce CD30 antibody. The modified T cells, called ATLCAR.CD30, will be able to target and attach to lymphoma cancer cells that carry the CD30 antigen. Once they are attached, the hope is that the T cells will attack and destroy the lymphoma cancer cells. To prepare the body for the ATLCAR.CD30 cells, participants will complete lymphodepletion with two chemotherapy agents. Lymphodepletion will happen over three days prior to ATLCAR.CD30 infusion. If participants respond to this treatment, and there are sufficient unused ATLCAR.CD 30 cells, they may be eligible to receive a second infusion. The second infusion will be given after a second lymphodepletion chemotherapy. Most of the clinic visits in this research will last between 1-8 hours. There are risks associated in participating in this research study. Risks of treatment include infection, fever, nausea, vomiting, neurotoxicity, and cytokine release syndrome which can include low blood pressure or difficulty breathing. Other risks are associated with study procedures, such as biopsies, imaging, infusion, and breach of confidentiality.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of immunotherapy called CAR T-cell therapy for a rare blood cancer called CD30-positive T-cell lymphoma. The treatment uses your own immune cells, which are collected, genetically modified in a lab to better attack cancer cells, and then infused back into your body. **You may be eligible if...** - You are 18 or older - You have been diagnosed with CD30-positive T-cell lymphoma confirmed by a biopsy - Your lymphoma has come back or stopped responding to at least two prior treatments - You are in generally good health (functional enough to do light activity) - You are not pregnant and willing to use contraception **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have an active HIV, HTLV, or Hepatitis C infection - You have active Hepatitis B infection - You are on high-dose steroids (equivalent to 10mg or more of prednisone daily) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALATLCAR.CD30 T cells

Autologous T Lymphocyte Chimeric Antigen Receptor cells targeted against the CD30 antigen at dose of 2 × 10\^8 CAR-T/m\^2 with a maximum dose of 5 × 10\^8 CAR-T cells

DRUGBendamustine

70 mg/m\^2 administered IV for 3 days for lymphodepletion 2-14 days prior to first cell infusion

DRUGFludarabine

30 mg/m\^2 administered IV for 3 days for lymphodepletion 2-14 days prior to first and second cell infusion

DRUGCyclophosphamide

300 mg/m\^2 administered IV for 3 days for lymphodepletion 2-14 days prior to second cell infusion and 2-14 days prior to the first cell infusion for subjects who have previously had hypersensitivity to bendamustine