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Phase I Study of the Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor for Relapsed CD30+ Hodgkin's Lymphoma and CD30+ Non-Hodgkin's Lymphoma (CART CD30)


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

Thank you

Trial Information

Phase I Study of the Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor for Relapsed CD30+ Hodgkin's Lymphoma and CD30+ Non-Hodgkin's Lymphoma (CART CD30)


When the patient enrolls on this study, they will be assigned a dose of CD30 chimeric
receptor-activated T cells. The dose level of cells that they will receive will not be based
on a medical determination of what is best for the patient, instead the dose is based on the
order in which the patient enrolled 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 the patient will need to have recovered from toxic
effects of previous chemotherapy for at least one week and not be receiving any other
investigational agents. The patient cannot have received any tumor vaccines within the
previous six weeks.

The patient will be given an injection of CD30 chimeric receptor-activated T cells into the
vein through an IV line at the assigned dose. The injection will take 1-10 minutes. We will
follow you in the clinic after the injection for up to 4 hours.

Medical tests before study treatment—

Before being treated, the patient will receive a series of standard medical tests:

- Physical exam

- Blood tests to measure blood cells, kidney and liver function

- Pregnancy test for women of child bearing potential

- Measurements of the tumor by scans and/or bone marrow studies

Medical tests during and after study treatment—

The patient will receive standard medical tests when they are getting the infusions and
after:

- Physical exams

- Blood tests to measure blood cells, kidney and liver function

- Measurements of the tumor by scans (CT/MRI/or PET) and/or bone marrow studies at time
of infusion and at 6 weeks after the infusion

To learn more about the way the CD30 chimeric receptor-activated T cells are working and how
long they last in the body, extra blood will be drawn.

If the patient has stable disease (the lymphoma did not grow) or there is a reduction in the
size of the lymphoma on imaging studies after the T-cell infusion, s/he can receive up to
six additional doses of the T cells at 8 to 12 weeks intervals if s/he wishes. After each
T-cell infusion, s/he will be monitored as described above.

Inclusion Criteria


INCLUSION CRITERIA:

PROCUREMENT:

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

- Diagnosis of recurrent 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 stem cell
transplantation

- CD30 positive tumor (result 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.

- Karnofsky or Lansky score greater than 60%

TREATMENT:

Diagnosis - CD30+ HL or CD30+ NHL:

1. During the Dose Escalation Phase: only adult patients with active disease failing
standard therapy

2. After Dose Escalation: any patient (children or adults) newly diagnosed, 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. (During dose escalation: only adult patients (age 18 and
older; After Dose Escalation: any patient (children ages 0-17 or adults)

- CD30 positive tumor

- 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 T cells with 15% or more expression of CD30CAR determined
by flow-cytometry.

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

- Adequate pulmonary function with FEV1, FVC and DLCO greater than or equal to 50%
of expected corrected for hemoglobin.

- 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:

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

TREATMENT:

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

- Received anti-CD30 antibody-based therapy within the previous 4 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:

Number of participants with adverse events as a measure of safety and tolerability of escalating doses of autologous activated T lymphocytes

Outcome Description:

To evaluate the safety of escalating doses of autologous activated T lymphocytes (ATL), genetically modified to express an artificial chimeric antigen receptor (CAR) that targets the CD30 molecule (CAR.CD30) and also contains the CD28 endodomain, 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

Authority:

United States: Food and Drug Administration

Study ID:

H-27721-CART CD30

NCT ID:

NCT01316146

Start Date:

December 2011

Completion Date:

December 2029

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Hodgkin's Lymphoma
  • Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma
  • Lymphoma
  • T lymphocytes
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

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