Compassionate Use Re-Infusion of ATLCAR.CD30

2019-04-17 12:55:22 | BioPortfolio


This protocol for compassionate use combines 2 different ways of fighting disease: antibodies and T cells. Both antibodies and T cells have been used to treat patients with cancers, and both have shown promise, but neither alone has been sufficient to cure most patients. This protocol combines both T cells and antibodies to create a more effective treatment. The investigational treatment is called autologous T lymphocyte chimeric antigen receptor cells targeted against the CD30 antigen (ATLCAR.CD30) administration.

Prior studies have shown that a new gene can be put into T cells and will increase their ability to recognize and kill cancer cells. The new gene that is put in the T cells in this study makes a piece of an antibody called anti-CD30. This antibody sticks to leukemia cells because they have a substance on the outside of the cells called CD30. For this protocol, the anti-CD30 antibody has been changed so that instead of floating free in the blood part of it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. These CD30 chimeric (combination) receptor-activated T cells seem to kill some of the tumor, but they do not last very long in the body and so their chances of fighting the cancer are unknown.

The primary purpose of this protocol is to treat a single patient with a second dose of ATLCAR.CD30 T cells.


Lymphodepleting Chemotherapy:

The patient will receive a lymphodepleting regimen of bendamustine 70mg/m2/day over 3 consecutive days and fludarabine 30mg/m2/day over 2 consecutive days. Bendamustine and fludarabine will be administered concomitantly. Dose reduction of bendamustine may occur per treating physician discretion based on prior toxicities and the clinical status of the patient.

Administration of ATLCAR.CD30 T cells:

Post lymphodepletion, if the patient meets eligibility criteria for cellular therapy, then will receive ATLCAR.CD30 T cells within 2-14 days after completing the pre-conditioning chemotherapy regimen. We will administer ATLCAR.CD30 T cells post lymphodepletion at a dose of 2 x 10^8 cells/m2.

Duration of Therapy:

Therapy under this compassionate use protocol involves 1 infusion of ATLCAR.CD30 cells.

Duration of Follow-up:

The patient will be followed for up to 15 years for replication-competent retrovirus evaluation or until death, whichever occurs first.

Study Design


Hodgkin Lymphoma, Adult


ATLCAR.CD30, Bendamustine, Fludarabine


Lineberger Comprehensive Cancer Center at University of North Carolina
Chapel Hill
North Carolina
United States


No longer available


UNC Lineberger Comprehensive Cancer Center

Results (where available)

View Results


Published on BioPortfolio: 2019-04-17T12:55:22-0400

Clinical Trials [2493 Associated Clinical Trials listed on BioPortfolio]

Phase I of CAR-T Cells Expressing CD30 and CCR4 for r/r CD30+ HL and NHL

The body has different ways of fighting infection and disease. No single way is perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies...

A Phase II Study With Bendamustine Plus Brentuximab Vedotin in Hodgkin's Lymphoma and CD30+ Peripheral T-cell Lymphoma in First Salvage Setting: the BBV Regimen

This is a single-arm, open-label, multicenter, phase 2 clinical trial aimed at evaluating the efficacy and safety of the combination of bendamustine and brentuximab vedotin as a first salv...

Study of CD30 CAR for Relapsed/Refractory CD30+ HL and CD30+ NHL

The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibod...

CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas

CAR-T cells have been validated effective in treating CD19 positive B cell lymphoma. Other lymphomas like Hodgkin's lymphoma and anaplastic large cell lymphoma are CD30 positive. In this s...

Administration of T Lymphocytes for Prevention of Relapse of Lymphomas

The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibod...

PubMed Articles [4995 Associated PubMed Articles listed on BioPortfolio]

First-Line Treatment of Patients With Indolent Non-Hodgkin Lymphoma or Mantle-Cell Lymphoma With Bendamustine Plus Rituximab Versus R-CHOP or R-CVP: Results of the BRIGHT 5-Year Follow-Up Study.

The BRIGHT study ( identifier: NCT00877006) was initiated to compare the efficacy and safety of bendamustine plus rituximab (BR) with either rituximab plus cyclophosphamide, doxorub...

Bendamustine for patients with indolent B cell lymphoproliferative malignancies including chronic lymphocytic leukaemia - an updated meta-analysis.

The question of which chemotherapy induction provides the best results for indolent lymphoma patients is yet unanswered. Different regimens have been compared, none of which has been shown to improve ...

Pregnancy Screening and Contraceptive Counseling in Young Women with Hodgkin Lymphoma: A Single Center Retrospective Review.

Chemotherapeutic agents used to treat Hodgkin lymphoma are teratogenic. Pregnancy screening before the start of chemotherapy is supported by clinical guidelines. There are limited data on pregnancy sc...

Non-Hodgkin Lymphoma in the Middle East Is Characterized by Low Incidence Rates With Advancing Age.

In the Middle East, incidence rate ratios (IRRs) of non-Hodgkin lymphoma (NHL) to Hodgkin lymphoma (HL) are more than 50% lower than the United States.

18F-FDG-PET metabolic metrics and International Prognostic Score for risk assessment in HIV-infected patients with Hodgkin lymphoma.

Baseline metabolic metrics on fluorine-18-fluorodeoxyglucose PET (F-FDG PET) have prognostic value in Hodgkin lymphoma. International Prognostic Score (IPS) is used in the risk stratification of Hodgk...

Medical and Biotech [MESH] Definitions

A nitrogen mustard compound that functions as an ALKYLATING ANTINEOPLASTIC AGENT and is used in the treatment of CHRONIC LYMPHOCYTIC LEUKEMIA and NON-HODGKIN'S LYMPHOMA.

Two or more distinct types of malignant lymphoid tumors occurring within a single organ or tissue at the same time. It may contain different types of non-Hodgkin lymphoma cells or both Hodgkin and non-Hodgkin lymphoma cells.

A systemic, large-cell, non-Hodgkin, malignant lymphoma characterized by cells with pleomorphic appearance and expressing the CD30 ANTIGEN. These so-called "hallmark" cells have lobulated and indented nuclei. This lymphoma is often mistaken for metastatic carcinoma and MALIGNANT HISTIOCYTOSIS.

A form of non-Hodgkin lymphoma having a usually diffuse pattern with both small and medium lymphocytes and small cleaved cells. It accounts for about 5% of adult non-Hodgkin lymphomas in the United States and Europe. The majority of mantle-cell lymphomas are associated with a t(11;14) translocation resulting in overexpression of the CYCLIN D1 gene (GENES, BCL-1).

Any of a group of malignant tumors of lymphoid tissue that differ from HODGKIN DISEASE, being more heterogeneous with respect to malignant cell lineage, clinical course, prognosis, and therapy. The only common feature among these tumors is the absence of giant REED-STERNBERG CELLS, a characteristic of Hodgkin's disease.

More From BioPortfolio on "Compassionate Use Re-Infusion of ATLCAR.CD30"

Quick Search


Relevant Topics

An antibody is a protein produced by the body's immune system when it detects harmful substances, called antigens. Examples of antigens include microorganisms (such as bacteria, fungi, parasites, and viruses) and chemicals. Antibodies may be produc...

Bioinformatics is the application of computer software and hardware to the management of biological data to create useful information. Computers are used to gather, store, analyze and integrate biological and genetic information which can then be applied...

  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...

Searches Linking to this Trial