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New treatment option for Hodgkin's Lymphoma
Official title CD30 CAR T Cells, Relapsed CD30 Expressing Lymphoma (RELY-30)
ClinicalTrials.gov ID: NCT02917083
What this study is testing
What is CAR T Cells?
CAR T Cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hodgkin's lymphoma.
Also referred to as CD30.CAR T Cells.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The subject has a type of lymph gland cancer called Lymphoma. The body has different ways of fighting infection and disease.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 75
You may be able to join if
- PROCUREMENT
- Diagnosis of relapsed/refractory HL or NHL.
- CD30 positive tumor as assayed in a CLIA certified pathology laboratory (result can be pending at this time)
- Hgb ≥ 7.0 (may be a transfused value)
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
You likely can't join if
- Active infection with HIV or HTLV (can be pending at this time).
- Active bacterial, fungal or viral infection. TREATMENT Exclusion Criteria:
- 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.
- people with rapidly progressive disease, defined as kinetic failure to previous chemotherapy.
- Bulky disease (defined as a 10 cm or greater mass or mediastinal disease with a transverse diameter exceeding 33% of the transthoracic diameter).
See the full eligibility criteria
- PROCUREMENT
- Diagnosis of relapsed/refractory HL or NHL.
- CD30 positive tumor as assayed in a CLIA certified pathology laboratory (result can be pending at this time)
- Hgb ≥ 7.0 (may be a transfused value)
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
- Karnofsky or Lansky score of \> 60% TREATMENT
- Diagnosis of relapsed/refractory HL or NHL.
- CD30-positive tumor as assayed in a CLIA certified pathology laboratory.
- 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.
- Bilirubin 1.5 times or less than the upper limit of normal.
- AST 3 times or less than the upper limit of normal.
- Estimated GFR \> 70 mL/min.
- Pulse oximetry of \> 90% on room air
- EKG shows no significant arrhythmias
- Karnofsky or Lansky score of \> 60%.
- Available autologous T cells with greater than or equal to 15% expression of CD30CAR determined by flow-cytometry.
- Recovered from all acute non-hematologic toxic effects of all prior chemotherapy.
- 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.
- 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.
- Informed consent explained to, understood by and signed by patient or guardian. PROCUREMENT
- Active infection with HIV or HTLV (can be pending at this time).
- Active bacterial, fungal or viral infection. TREATMENT Exclusion Criteria:
- 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.
- people with rapidly progressive disease, defined as kinetic failure to previous chemotherapy.
- Bulky disease (defined as a 10 cm or greater mass or mediastinal disease with a transverse diameter exceeding 33% of the transthoracic diameter).
- 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 at a dose equivalent to 0.5 mg/kg/day of prednisone or higher.
- Active hemorrhagic cystitis.
- Active bacterial, viral or fungal infection.
- Symptomatic cardiac disease (NYHA Class III or IV disease).
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.