TrialPath
Recruiting

CD30 CAR T Cells, Relapsed CD30 Expressing Lymphoma (RELY-30)

NCT02917083 · Baylor College of Medicine
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
Phase I Study of Relapsed CD30 Expressing Lymphoma Treated With CD30 CAR T Cells (RELY-30)
About this study
To prepare the CD30.CAR T cells, research staff will take some blood from the subject. This would be drawn as two separate blood collections. Alternatively, if the subject's blood counts are low, staff may collect the cells needed to prepare T cells by a pheresis procedure. This procedure will involve placing a needle in both arms, collecting the cells over 3 to 6 hours during which the subject will be required to lie relatively still. After the T cells have been collected, some of them will be activated stimulating them with antibodies and will then be infected with a retroviral vector (a special virus that can carries a new gene into cells) containing a new gene called anti-CD30 that will make an antibody to lymphoma cells. The trained cells are called CD30.CAR T cells. Then, the cells will be tested to make sure that they kill lymphoma cells that express the CD30 antigen and not normal cells. The cells generated will be frozen and stored to give back to the subject. This is a dose escalation study. This means that at the beginning, patients will be started on the lowest doses (1 of 3 different levels) of CD30.CAR 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 3 dose levels are studied. If the side effects are too severe, the dose will be lowered or the T cell infusions will be stopped. 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. Subjects will be given one injection of CD30.CAR T cells. The injection will be on Day 0. The subject may be given a dose of Benadryl and Tylenol before the injection of T cells to minimize any possible allergic reaction. The injection will take 1-10 minutes. The subject will be monitored in the clinic after each injection for at least 3 hours. At the discretion of the study doctor, if the subject has stable disease (the lymphoma did not grow) or there is a reduction in the size of the lymphoma on imaging studies at week 8 after the T-cell infusion or on subsequent evaluations, then the subject can receive up to six additional doses of the T cells at 8 to 12 weeks intervals. After each T cell injection, the subject will be monitored as described above. To learn more about the way the CD30.CAR T cells are working and how long they last in the body, extra blood will be drawn. On the day that the subject receives the cells, blood will be taken before the cells are given and several hours afterwards. For patients receiving lymphodepletion chemotherapy blood will also be collected prior to the start of chemotherapy. Other blood will be drawn at 1 week, 2 weeks, 3 weeks (optional), 4 weeks, 6 weeks and 8 weeks, every 3 months for 1 year, every 6 months for 4 years, then yearly for a total of 15 years.
Eligibility criteria
PROCUREMENT Inclusion Criteria: 1. Diagnosis of relapsed/refractory HL or NHL. 2. CD30 positive tumor as assayed in a CLIA certified pathology laboratory (result can be pending at this time) 3. Hgb ≥ 7.0 (may be a transfused value) 4. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. 5. Karnofsky or Lansky score of \> 60% TREATMENT Inclusion Criteria: 1. Diagnosis of relapsed/refractory HL or NHL. 2. CD30-positive tumor as assayed in a CLIA certified pathology laboratory. 3. Age 16 to 75 for the first three patients on a dose level; thereafter, if no DLT, patients aged 12 to 75 can be treated on that dose level. 4. Bilirubin 1.5 times or less than the upper limit of normal. 5. AST 3 times or less than the upper limit of normal. 6. Estimated GFR \> 70 mL/min. 7. Pulse oximetry of \> 90% on room air 8. EKG shows no significant arrhythmias 9. Karnofsky or Lansky score of \> 60%. 10. Available autologous T cells with greater than or equal to 15% expression of CD30CAR determined by flow-cytometry. 11. Recovered from all acute non-hematologic toxic effects of all prior chemotherapy. 12. Adequate pulmonary function with FEV1, FVC and DLCO (or DLCO/VA, as clinically appropriate) greater than or equal to 50% of expected corrected for hemoglobin. 13. 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. 14. Informed consent explained to, understood by and signed by patient or guardian. PROCUREMENT Exclusion Criteria: 1. Active infection with HIV or HTLV (can be pending at this time). 2. Active bacterial, fungal or viral infection. TREATMENT Exclusion Criteria: 1. Currently receiving any investigational agents or received any tumor vaccines within the previous six weeks. 2. Received anti-CD30 antibody-based therapy within the previous 4 weeks. 3. Subjects with rapidly progressive disease, defined as kinetic failure to previous chemotherapy. 4. Bulky disease (defined as a 10 cm or greater mass or mediastinal disease with a transverse diameter exceeding 33% of the transthoracic diameter). 5. History of hypersensitivity reactions to murine protein-containing products. 6. Pregnant or lactating. 7. Tumor in a location where enlargement could cause airway obstruction. 8. Current use of systemic corticosteroids at a dose equivalent to 0.5 mg/kg/day of prednisone or higher. 9. Active hemorrhagic cystitis. 10. Active bacterial, viral or fungal infection. 11. Symptomatic cardiac disease (NYHA Class III or IV disease).
Study design
Enrollment target: 60 participants
Allocation: na
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2017-05-08
Estimated completion: 2040-02
Last updated: 2026-06-10
Interventions
Genetic: CAR T Cells
Primary outcomes
  • Number of Patients with Dose-Limiting Toxicities (DLT) (6 weeks)
Sponsor
Baylor College of Medicine · other
With: The Methodist Hospital Research Institute
Contacts & investigators
ContactCarlos A Ramos, MD · contact · caramos@bcm.edu · 832-824-4817
ContactVicky Torrano, RN · contact · vxtorran@txch.org · 832-824-7821
InvestigatorCarlos A Ramos, MD · principal_investigator, Baylor College of Medicine
All locations (2)
Houston Methodist HospitalRecruiting
Houston, Texas, United States
Texas Children's HospitalRecruiting
Houston, Texas, United States
CD30 CAR T Cells, Relapsed CD30 Expressing Lymphoma (RELY-30) · TrialPath