CD30 CAR for Relapsed/Refractory CD30+ T Cell Lymphoma

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT04083495
Phase
PHASE2
Status
Recruiting
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Conditions

  • Peripheral T Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • ATLCAR.CD30 T cells — BIOLOGICAL
    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
  • Bendamustine — DRUG
    70 mg/m\^2 administered IV for 3 days for lymphodepletion 2-14 days prior to first cell infusion
  • Fludarabine — DRUG
    30 mg/m\^2 administered IV for 3 days for lymphodepletion 2-14 days prior to first and second cell infusion
  • Cyclophosphamide — DRUG
    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

Study Details

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.

Key Dates

Start date
Sep 17, 2019
Status verified
Sep 2025
Primary completion
Feb 23, 2028
Completion
Aug 31, 2038

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ATLCAR.CD30 cells
    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

Primary Outcome Measure

Progression free survival (PFS) after administration of the ATLCAR.CD30 in subjects with relapsed/refractory CD30+ peripheral T cell lymphoma [ Time Frame: 8 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Lineberger Comprehensive Cancer Center at University of North CarolinaChapel HillNorth Carolina27599
Catherine Cheng
[email protected]
919-445-4208
Caroline Babinec
[email protected]
919-962-7426
Anne Beaven, MD (PRINCIPAL_INVESTIGATOR)
Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157
Jana Hall Project Manager
[email protected]
919-966-4432
Caroline Jones Dinkins
[email protected]
919-966-4432
Rakhee Vaidya, MD (PRINCIPAL_INVESTIGATOR)

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Lineberger Comprehensive Cancer Center at University of North Carolina· Chapel Hill, NCWake Forest Baptist Medical Center· Winston-Salem, NC

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