NCT01555892 Cytotoxic T-Lymphocytes for EBV-positive Lymphoma, GRALE
| NCT ID | NCT01555892 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Baylor College of Medicine |
| Condition | Hodgkin's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 136 participants |
| Start Date | 2013-01-14 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 136 participants in total. It began in 2013-01-14 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Subjects have a type of lymph gland disease called Hodgkin or non-Hodgkin Lymphoma or T/NK-lymphoproliferative disease or severe chronic active Epstein Barr Virus (CAEBV) which has come back, is at risk of coming back, or has not gone away after treatment, including the best treatment investigators know for these diseases. Some of these patients show signs of virus that is called Epstein Barr virus (EBV) that causes mononucleosis or glandular fever ("mono" or the "kissing disease") before or at the time of their diagnosis. EBV is found in the cancer cells of up to half the patients with HD and NHL, suggesting that it may play a role in causing Lymphoma. The cancer cells and some immune system cells infected by EBV are able to hide from the body's immune system and escape destruction. Investigators want to see if special white blood cells, called GRALE T cells, that have been trained to kill EBV infected cells can survive in the blood and affect the tumor. Investigators have used this sort of therapy to treat a different type of cancer called post transplant lymphoma. In this type of cancer the tumor cells have 9 proteins made by EBV on their surface. Investigators grew T cells in the lab that recognized all 9 proteins and were able to successfully prevent and treat post transplant lymphoma. However, in HD and NHL, T/NK-lymphoproliferative disease, and CAEBV, the tumor cells and B cells only express 4 EBV proteins. In a previous study, the investigators made T cells that recognized all 9 proteins and gave them to patients with HD. Some patients had a partial response to this therapy but no patients had a complete response. The investigators then did follow up studies where investigators made T cells that recognized the 2 EBV proteins seen in patients with lymphoma, T/NK-lymphoproliferative disease and CAEBV. Investigators have treated over 50 people on those studies. About 60% of those patients who had disease at the time they got the cells had responses including some patients with complete responses. This study will expand on those results and the investigators will try and make the T cells in the lab in a simpler faster way. These cells are called GRALE T cells. These GRALE T cells are an investigational product not approved by the FDA. The purpose of this study is to find the largest safe dose of LMP-specific cytotoxic GRALE T cells created using this new manufacturing technique. Investigators will learn what the side effects are and to see whether this therapy might help patients with HD or NHL or EBV associated T/NK-lymphoproliferative disease or CAEBV.
Eligibility Criteria
Inclusion Criteria at time of Procurement 1. Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non-Hodgkin's Lymphoma, (regardless of the histological subtype) or EBV (associated)-T/NK-lymphoproliferative disease or Severe Chronic Active EBV (CAEBV) who may subsequently be eligible for the treatment component 2. EBV positive tumor (can be pending at this time) 3. Weighs at least 12kg 4. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. Inclusion Criteria at time of Infusion 1. Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non-Hodgkin's Lymphoma (regardless of histologic subtype), or EBV (associated)-T/NK-lymphoproliferative disease or Severe Chronic Active EBV (CAEBV)\* and In second or subsequent relapse (or first relapse or with active disease if immunosuppressive chemotherapy contraindicated or multiply relapsed patients in remission who have a high risk of relapse)\*\* OR any patient with primary disease or in first remission if immunosuppressive chemotherapy is contraindicated, e.g. patients who develop Hodgkin disease after solid organ transplantation or if the Lymphoma is a second malignancy e.g. a Richter's transformation of CLL. (Group A) OR In remission or with minimal residual disease status after autologous or syngeneic SCT. (Group B) 2. EBV positive tumor 3. Patients with bilirubin less than or equal to 3x upper limit of normal, AST less than or equal 5x upper limit of normal, and hemoglobin greater than or equal to 7.0 (may be a transfused value). 4. Patients with a creatinine less than or equal to 2x upper limit of normal for age 5. Pulse oximetry of \> 90% on room air 6. Patients should have been off other investigational therapy for 4 weeks prior to entry in this study. PD1/PDL inhibitors will be allowed if medically indicated. 7. Patients with a Karnofsky/Lansky score of greater than or equal to 50 8. 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. 9. Informed consent explained to, understood and signed by patient/guardian. Patient/guardian given copy of informed consent. * CAEBV is defined as patients with high EBV viral load in plasma or PBMC (\> 4000 genomes per ug PBMC DNA) and/or biopsy tissue positive for EBV * Patients with relapsed or refractory lymphoma that are eligible for a stem cell transplant will not be treated on this study as an alternative to transplant. Exclusion Criteria at Time of Procurement 1\. Active infection with HIV, HTLV, HBV, HCV (can be pending at this time) Exclusion Criteria at Time of Infusion 1. Pregnant or lactating 2. Severe intercurrent infection. 3. Current use of systemic corticosteroids \> 0.5 mg/kg/day
Contact & Investigator
Helen E Heslop, MD
PRINCIPAL INVESTIGATOR
Baylor College of Medicine
Frequently Asked Questions
Who can join the NCT01555892 clinical trial?
This trial is open to participants of all sexes, studying Hodgkin's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT01555892 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT01555892 currently recruiting?
Yes, NCT01555892 is actively recruiting participants. Contact the research team at hheslop@bcm.edu for enrollment information.
Where is the NCT01555892 trial being conducted?
This trial is being conducted at Houston, United States, Houston, United States, Houston, United States.
Who is sponsoring the NCT01555892 clinical trial?
NCT01555892 is sponsored by Baylor College of Medicine. The principal investigator is Helen E Heslop, MD at Baylor College of Medicine. The trial plans to enroll 136 participants.