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Phase I Study of the Administration of EBV CTLs Expressing CD30 Chimeric Receptors for Relapsed CD30+ Hodgkin's Lymphoma and CD30+ Non-Hodgkin's Lymphoma (CAR CD 30)


Phase 1
N/A
N/A
Open (Enrolling)
Both
Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma

Thank you

Trial Information

Phase I Study of the Administration of EBV CTLs Expressing CD30 Chimeric Receptors for Relapsed CD30+ Hodgkin's Lymphoma and CD30+ Non-Hodgkin's Lymphoma (CAR CD 30)


Earlier, patients gave us blood to make CD30 chimeric-EBV CTLs in the lab. These cells were
grown and frozen for the patient. To get the CD30 antibody to attach to the surface of the T
cell, we inserted the antibody gene into the T cell. This is done with a virus called a
retrovirus that has been made for this study and will carry the antibody gene into the T
cell. Because the patient will have received cells with a new gene in them they will be
followed for a total of 15 years to see if there are any long term side effects of gene
transfer.

When the patient is enrolled on this study, they will be assigned to one of the following
dose levels of CD30 chimeric receptor-EBV CTLs.

- 2×10^7 cells/m2

- 5x10^7 cells/m2

- 1×10^8 cells/m2

The dose level of cells that they will receive will not be based on a medical determination
of what is best for them, instead the dose is based on the order in which the patient
enrolls on the study relative to other participants. Subjects enrolled earlier in the study
will receive a lower dose of cells than those enrolled later in the study. The risks of harm
and discomfort from the study treatment may bear some relationship to the dose level. The
potential for direct benefit, if any, may also vary with the dose level. To enroll on this
study they will need to have recovered from toxic effects of previous chemotherapy for at
least one week and not be receiving any other investigational agents. Patients cannot have
received any tumor vaccines within the previous six weeks.


INCLUSION CRITERIA:

PROCUREMENT

Inclusion Criteria:



- Referred patients will initially be consented for procurement of blood for generation
of the transduced CTL Line. Eligibility criteria at this stage include:

- Diagnosis of recurrent HL or NHL, or newly diagnosed patients unable to receive or
complete standard therapy OR diagnosis of relapsed/refractory HL or NHL with a
treatment plan that will include high dose therapy and stem cell transplantation

- CD30 positive tumor (can be pending at this time)

- EBV seropositivity (can be pending at this time)

- Hgb > 8.0

- Informed consent explained to, understood by and signed by patient/guardian.
Patient/guardian given copy of informed consent.

TREAMENT

Inclusion Criteria:

Patients must meet the following eligibility criteria to be
included for treatment:

- Diagnosis - CD30+ HL or CD30+ NHL

- During the dose escalation phase: only adult patients (age 18 and older) with active
disease failing standard therapy

- After dose escalation: any patient (children or adults) with relapsed CD30+ HL or
CD30+ NHL or newly diagnosed patients unable to receive or complete standard therapy
OR diagnosis of relapsed/refractory CD30+ HL or CD30+ NHL with a treatment plan that
will include high dose therapy and autologous stem cell transplantation.

- CD30 positive tumor

- EBV seropositivity.

- Recovered from acute toxic effects of all prior chemotherapy at least one week and 30
days from prior chemotherapy before entering this study.

- Bilirubin 1.5 times or less than upper limit of normal.

- AST 3 times or less than upper limit of normal.

- Serum creatinine 1.5 times or less than upper limit of normal.

- Pulse oximetry of > 90% on room air

- Karnofsky or Lansky score of > 60%.

- Available autologous transduced EBV-specific cytotoxic T lymphocytes with 15% or more
expression of CD30CAR determined by flow-cytometry.

- Adequate pulmonary function with FEV1, FVC and DLCO 50% or greater of expected
corrected for hemoglobin. Exceptions may be allowed for patients with pulmonary
involvement after discussing with PI.

- Sexually active patients must be willing to utilize one of the more effective birth
control methods during the study and for 6 months after the study is concluded. The
male partner should use a condom.

- Patients or legal guardians must sign an informed consent indicating that they are
aware this is a research study and have been told of its possible benefits and toxic
side effects. Patients or their guardians will be given a copy of the consent form.

EXCLUSION CRITERIA:

PROCUREMENT Exclusion Criteria:

- Active infection with HIV, HTLV, HBV, HCV (can be pending at this time).

- Received rituximab within 4 months of blood collection for LCL initiation (unless
circulating CD19+ B are =/>2%)

TREATMENT Exclusion Criteria:

- Currently receiving any investigational agents or received any tumor vaccines within
the previous six weeks.

- Received anti-CD30 antibody-based therapy within the previous 6 weeks.

- History of hypersensitivity reactions to murine protein-containing products.

- Pregnant or lactating.

- Tumor in a location where enlargement could cause airway obstruction.

- Current use of systemic corticosteroids.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety of escalating doses of autologous EBV-specific cytotoxic T-lymphocytes (CTLs),

Outcome Description:

To evaluate the safety of escalating doses of autologous EBV-specific cytotoxic T-lymphocytes (CTLs), genetically modified to express an artificial T-cell receptor (CAR) targeting the CD30 molecule (CAR.CD30), in patients with CD30+ refractory/relapsed Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL)

Outcome Time Frame:

6 weeks

Safety Issue:

Yes

Principal Investigator

Helen E Heslop, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor College of Medicine/Center for Cell and Gene Therapy

Authority:

United States: Institutional Review Board

Study ID:

26617-CAR CD 30

NCT ID:

NCT01192464

Start Date:

March 2011

Completion Date:

October 2026

Related Keywords:

  • Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma
  • Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Texas Children's HospitalHouston, Texas  
The Methodist HospitalHouston, Texas  77030