Can a smart immune cell with a kill switch beat tough lymphomas?
NCT ID NCT07729397
First seen Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time
Summary
This Phase 1 trial tests a new type of cell therapy for people with relapsed or refractory CD30-positive lymphomas, including Hodgkin lymphoma and certain non-Hodgkin lymphomas. The treatment uses a patient's own immune cells that are genetically engineered to recognize and attack CD30 on cancer cells, plus a built-in safety switch to control side effects. The main goal is to see if the treatment is safe, while also checking whether it can shrink tumors and how long the engineered cells last in the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- engineered immune cells (C7R.CD30-CAR-EBVSTs) that target CD30 on lymphoma cells and include a safety switch
- What this could lead to
- If successful, this approach could offer a new treatment option for people with hard-to-treat CD30-positive lymphomas, potentially leading to durable remissions.
- What could go wrong
- This is an early Phase 1 trial with only 21 participants, so safety and effectiveness are not yet established. There are risks of serious side effects like cytokine release syndrome and organ toxicity.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 21 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Feb 2044
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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16 to 75 years
- 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.
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: 1. Diagnosis of relapsed or refractory Hodgkin lymphoma or non-Hodgkin lymphoma. 2. CD30 positive tumor (can be pending at this time) as assayed in a CLIA certified Pathology Laboratory. 3. Age 16 to 75 years. 4. Hemoglobin ≥7.0(may be transfused value). 5. Karnofsky or Lansky score of \> 60% 6. Informed consent explained to, understood by and signed by patient or guardian. Patient or guardian given copy of informed consent. Procurement Exclusion Criteria: 1. Active HIV or HTLV infection (testing may be pending at procurement). 2. 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: 1. 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 2. CD30 expression confirmed in a CLIA-certified laboratory. Recovered from all acute non-hematologic toxic effects of all prior chemotherapy 3. Age 16 to 75 years. 4. 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). 5. AST ˂ 3 times the upper limit of normal 6. Estimated GFR \> 50 mL/min 7. Pulse oximetry of \> 90% on room air 8. Karnofsky or Lansky score of \> 60% 9. 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 10. Informed consent explained to, understood by and signed by patient/guardian. Patient/Guardian given copy of informed consent. Treatment Exclusion Criteria: 1. Received an investigational cell therapy or vaccine within the past 6 weeks. 2. Received an investigational small molecule within the past 2 weeks. 3. Received anti-CD30 antibody-based therapy within the previous 4 weeks. 4. History of hypersensitivity reactions to murine protein-containing products 5. Pregnancy or breastfeeding. 6. Tumor in a location where enlargement could cause airway obstruction (determined at the investigators' discretion) 7. Current use of systemic corticosteroids at a dose equivalent to higher than 10 mg/day of prednisone. 8. Active significant, uncontrolled bacterial, viral or fungal infection. 9. Symptomatic cardiac disease (NYHA Class III or IV disease).
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Houston Methodist Hospital
Houston, Texas, 77030, United States
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- Patient's own t cells engineered to hunt lymphoma in early trial
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- Can a calming drug make cord blood transplants safer?
- Can a tiny device speed up cancer diagnosis for people with HIV?