Status:
ACTIVE_NOT_RECRUITING
EBV CTLs Expressing CD30 Chimeric Receptors For CD 30+ Lymphoma
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Center for Cell and Gene Therapy, Baylor College of Medicine
The Methodist Hospital Research Institute
Conditions:
Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
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: antibodies and T ce...
Detailed Description
The EBV CTLs will be made for specific patients. First blood will be collected from the patient and then the the CD30 chimeric-EBV CTLs will be created in the lab. The cells will then be grown and fro...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- PROCUREMENT
- 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 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
- 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
Key Trial Info
Start Date :
May 10 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2033
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01192464
Start Date
May 10 2011
End Date
October 1 2033
Last Update
February 4 2025
Active Locations (2)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030
2
Texas Children's Hospital
Houston, Texas, United States, 77030