Know Cancer

or
forgot password

Administration of Tumor-Associated Antigen (TAA)-Specific Cytotoxic T-Lymphocytes to Patients With Active or Relapsed Hodgkin or Non-Hodgkin Lymphoma


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

Thank you

Trial Information

Administration of Tumor-Associated Antigen (TAA)-Specific Cytotoxic T-Lymphocytes to Patients With Active or Relapsed Hodgkin or Non-Hodgkin Lymphoma


The patient will give blood to make TAA specific cytotoxic T cells in the lab. These cells
will be grown and frozen. The time from the collection of the blood to make the T cells to
when the cells are given back to the patient is about 1 to 2 months.

The cells will then be injected by IV into the patient over 10 minutes. Initially, two doses
of T cells will be given two weeks apart. The patient may be eligible to receive up to six
additional doses of the T cells at 6-8 week intervals. All of the treatments will be given
by the Center for Cell and Gene Therapy at the Methodist Hospital or Texas Children's
Hospital.

There are 2 stages of this study: an antigen-escalation phase and a dose-escalation stage.

The antigen-Escalation phase will be first. Patients will receive TAA-specific T cells
targeting first 1 and then 2 TAAs. Once this schedule proves safe, the next group of
patients will receive TAA-specific T cells targeting first 2 and then 3 TAAs. This process
will continue until all 4 levels are studied. This means that the final cohort of patients
will receive TAA-specific T cells targeting first 4 and then 5 TAAs. If the side effects are
too severe, the number of TAAs being targeted will be lowered or the T cell injections will
be stopped.

After the antigen escalation phase the dose escalation phase will begin. Patients will be
started on the lowest dose (1 of 4 different levels) of T cells. Once that dose schedule
proves safe, the next group of patients will be started at a higher dose. This process will
continue until all 4 dose levels are studies. If the side effects are too severe, the dose
will be lowered or the T cell injections will be stopped.

For both stages, patients will be followed after the injections up to one year from the last
infusion.

Study Duration: Patients will be on study for approximately one year. If patients receive
additional doses of the T cells as described above, the patient will be followed until 1
year after the last dose of T-cells.


Inclusion Criteria:



PROCUREMENT:

1. Any patient, at least 18 years old regardless of sex with a diagnosis of Hodgkin's or
non-Hodgkin's Lymphoma:

- Group A:

- with active disease.

- in second or subsequent relapse

- in first relapse for indolent lymphoma after first line therapy for relapse

- or first relapse if immunosuppressive chemotherapy contraindicated.

- primary refractory disease or if persistent disease after first line
therapy of relapse.

- or multiply relapsed patients in remission who are at a high risk of relapse

- or the Lymphoma is a second malignancy e.g. a Richters transformation of CLL
after failing frontline therapy

OR

- Group B: After autologous or syngeneic SCT (as adjuvant therapy)

2. Life expectancy of 6 weeks or greater.

3. Hgb greater than 8.0

4. Patient, parent/guardian able to give informed consent.

Inclusion Criteria:



TREATMENT:

1. Any patient, at least 18 yrs old regardless of sex, with a diagnosis of Hodgkin's or
non-Hodgkin's Lymphoma:

Group A:

- with active disease

- in second or subsequent relapse

- in first relapse for indolent lymphoma after first line therapy for relapse

- or first relapse if immunosuppressive chemotherapy contraindicated

- primary refractory disease or if persistent disease after first line
therapy of relapse

- or multiply relapsed patients in remission who are at a high risk of relapse)

- or the Lymphoma is a second malignancy e.g. a Richters transformation of CLL
after failing front line therapy.

OR

- Group B: After autologous or syngeneic SCT (as adjuvant therapy)

2. Life expectancy of 6 weeks or greater.

3. Karnofsky/Lansky score of 50 or greater.

4. Bilirubin 2x or less of upper limit of normal, AST 3x or less than the upper limit of
normal, and Hgb >8.0

5. Creatinine 2x or less of upper limit of normal for age.

6. Patients should have been off other investigational therapy for one month prior to
entry in this study.

7. Patients should have been off conventional therapy for at least 1 week prior to entry
in this study

8. Patient able to give informed consent.

9. Due to unknown effects of this therapy on a fetus, pregnant women are excluded from
this research. The male partner should use a condom Females of child-bearing
potential should use of at least two forms of contraception unless female has had a
hysterectomy or tubal ligation.

Exclusion Criteria:

PROCUREMENT:

1. Patients with severe intercurrent infection.

2. Donors who are HIV positive at time of procurement. (test can be pending)

TREATMENT:

1. Patients with severe intercurrent infection.

2. Patients receiving systemic corticosteroids.

3. Pregnant.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Assessment of patients with adverse events

Outcome Description:

To determine the safety of 2 intravenous injections of autologous TAA-specific cytotoxic T-lymphocytes (CTL) in patients with Hodgkin's or non-Hodgkin's lymphoma.

Outcome Time Frame:

8 weeks

Safety Issue:

Yes

Principal Investigator

Catherine M Bollard, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor College of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

H-27471-TACTAL

NCT ID:

NCT01333046

Start Date:

January 2012

Completion Date:

January 2019

Related Keywords:

  • Hodgkin Lymphoma
  • Non-Hodgkin Lymphoma
  • Hodgkin Disease
  • Hodgkin Lymphoma
  • Non-Hodgkin Lymphoma
  • CTL
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Texas Children's Hospital Houston, Texas  
The Methodist Hospital Houston, Texas  77030