Engineered T cells for CD30-positive lymphoma that has returned or not responded
Tests the safety of modified T cells in people with relapsed CD30-positive lymphoma.
Plain-language title generated from the registry record
Registry title: Autologous IC-Nine, CD30 CAR, and Constitutive IL7R Expressing EBVST for CD30 Lymphoma (ANCILE-30)
Key facts
- Where
- Houston, United StatesSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 75 years old?
Source: NCT07729397, who can take part
Where in United States
- Houston Methodist HospitalHouston, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Methodist Hospital Research Institute
- Trial code
- NCT07729397
- Record updated
- 27 July 2026
- Original description
This Phase I study will evaluate the safety of autologous Epstein-Barr virus-specific T lymphocytes modified to express a constitutively active IL7 receptor (C7R) and a chimeric antigen receptor (CAR) for CD30 (C7R.CD30-CAR-EBVSTs) in patients with relapsed or refractory CD30-positive lymphomas.Read full original descriptionShow less
Autologous IC-Nine, CD30 CAR, and Constitutive IL7R Expressing EBVST for CD30 Lymphoma (ANCILE-30)
This Phase I study will evaluate the safety of autologous Epstein-Barr virus-specific T lymphocytes modified to express a constitutively active IL7 receptor (C7R) and a chimeric antigen receptor (CAR) for CD30 (C7R.CD30-CAR-EBVSTs) in patients with relapsed or refractory CD30-positive lymphomas.
Participants who meet procurement eligibility criteria will undergo collection of peripheral blood mononuclear cells for manufacture of the investigational product. Participants with a successfully manufactured product who continue to meet treatment eligibility criteria will receive lymphodepleting chemotherapy followed by infusion of autologous C7R.CD30-CAR-EBVSTs.
The primary objective is to evaluate safety. Secondary and exploratory objectives include evaluation of antitumor effect, expansion and persistence of the infused cells, and the association between immunological parameters, safety, and clinical response.
Procurement Inclusion Criteria:; Participants must meet the protocol-defined procurement eligibility criteria before collection of peripheral blood mononuclear cells for manufacture of the investigational product, including:; Diagnosis of relapsed or refractory Hodgkin lymphoma or non-Hodgkin lymphoma; CD30 positive tumor (can be pending at this time) as assayed in a CLIA certified Pathology Laboratory; Age 16 to 75 years; Hemoglobin ≥7.0(may be transfused value); Karnofsky or Lansky score of > 60%; Informed consent explained to, understood by and signed by patient or guardian. Patient or guardian given copy of informed consent; Procurement Exclusion Criteria:; Active HIV or HTLV infection (testing may be pending at procurement); Active bacterial, fungal, or viral infection; ____________________________________________________________________________; Treatment Inclusion Criteria:; Participants with a successfully manufactured product must continue to satisfy the protocol-defined treatment eligibility criteria before receiving study treatment, including:; Diagnosis and clinical course falling into one of the following categories:; Hodgkin lymphoma; CD30+ aggressive B-cell lymphoma; ALK-negative anaplastic T cell lymphoma or other peripheral T- cell lymphoma; ALK-positive anaplastic T cell lymphoma; CD30 expression confirmed in a CLIA-certified laboratory. Recovered from all acute non-hematologic toxic effects of all prior chemotherapy; Age 16 to 75 years; Bilirubin ≤ 2 times the upper limit of normal (except for Gilbert syndrome, where the criteria will be Bilirubin ≤ 3 times the upper limit of normal); AST ˂ 3 times the upper limit of normal; Estimated GFR > 50 mL/min; Pulse oximetry of > 90% on room air; Karnofsky or Lansky score of > 60%; Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after study is concluded. Male partner should use a condom; Informed consent explained to, understood by and signed by patient/guardian. Patient/Guardian given copy of informed consent; Treatment Exclusion Criteria:; Received an investigational cell therapy or vaccine within the past 6 weeks; Received an investigational small molecule within the past 2 weeks; Received anti-CD30 antibody-based therapy within the previous 4 weeks; History of hypersensitivity reactions to murine protein-containing products; Pregnancy or breastfeeding; Tumor in a location where enlargement could cause airway obstruction (determined at the investigators' discretion); Current use of systemic corticosteroids at a dose equivalent to higher than 10 mg/day of prednisone; Active significant, uncontrolled bacterial, viral or fungal infection; Symptomatic cardiac disease (NYHA Class III or IV disease).