Engineered immune cells take aim at Hard-to-Treat lymphoma
NCT ID NCT01192464
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This early-phase study tests a new treatment for people with Hodgkin or non-Hodgkin lymphoma that has returned or not responded to standard therapy. Researchers take a patient's own immune cells (T cells), add a special receptor that targets the CD30 protein found on lymphoma cells, and also train them to recognize the common EBV virus to help them last longer in the body. The main goal is to check the safety of these modified cells and see if they can shrink tumors.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2011
- Expected to finish
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Oct 2033
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
INCLUSION CRITERIA: PROCUREMENT Inclusion Criteria: * 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 Inclusion Criteria: 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 Criteria: * 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 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 6 weeks. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Houston Methodist Hospital
Houston, Texas, 77030, United States
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Texas Children's Hospital
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Engineered t cells with a kill switch aim to make stem cell transplants safer
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- Engineered t cells take on lymphoma in early trial
- New 'In-Body' CAR-T therapy takes aim at Hard-to-Treat lymphoma
- Experimental 'In-Situ' vaccine aims to train immune system against three cancers