Reprogrammed immune cells target CD30-Positive lymphoma in early trial
NCT ID NCT07048353
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
Researchers are testing a treatment called CD30 CAR-T cell therapy in adults with CD30-positive lymphoma that has returned or stopped responding to at least two prior treatments. The therapy involves collecting a patient's T cells, modifying them to recognize and attack CD30-positive cancer cells, and infusing them back. This early-phase study aims to find a safe dose and see how well the treatment works, measuring side effects and response rates in about 15 participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CD30-targeted CAR-T cell therapy, a treatment that reprograms a patient's own immune T cells to attack lymphoma cells
- What this could lead to
- If it works, this could offer a new treatment option for people whose CD30-positive lymphoma has come back or stopped responding to standard therapy.
- What could go wrong
- This is a very early, small study of 15 people, so it may not show clear benefit or may cause serious immune-related side effects. Results in this group may not apply to everyone with lymphoma.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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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18 to 65 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.
Inclusion Criteria: * Age≥18 years and ≤65years,female and male; * CD30+ recurrent/refractory malignant hematological malignancies, experienced recurrence (disease progression after treatment remission) or refractory (previous systemic treatment did not achieve CR) after ≥ 2-line systemic treatment; * CD30 expression \>10% by immunohistochemistry; * At least 1 measurable lesion can be measured according to theLugano 2014 evaluation criteria; * The estimated survival time ≥3 months; * ECOG performance status 0-2,KPS\>60%; * Sufficient organ function:ALT,AST≤2.5×ULN,patients with liver invasion can be relaxed to ≤ 5 x ULN;serum total bilirubin\<34 μmol/L;creatinine clearance rate\>30 mL/min;EF≥40%;No pericardial effusion and obvious arrhythmia;SpO2≥92%; * ALC ≥0.5×109/L,PLT\>30×109/L,Hb\>80 g/L and subjects had apheresis venous access and no contraindications for blood cell separation; * MRI showed no central involvement of lymphoma; * Patients with fertility must be willing to be able to use reliable contraceptive measures ; * The subject or legal guardian can understand and voluntarily sign the written informed consent. Exclusion Criteria: * Lymphoma-associated hemophagic cell syndrome; * Pregnant or lactating women, and women who have a pregnancy plan within six months; * Hepatitis B(HBsAg、HBsAb、HBeAg、HBeAb、HBcAb),Hepatitis C(Anti-HCV),Anti-HIV Ⅰ/Ⅱ and anti-TP positive(Hepatitis B DNA test is negative except); * Suffered from other malignant tumors, except for for skin basal cell carcinoma, skin squamous cell carcinoma and cervical carcinoma in situ undergoing the radical treatment; * Received Anti-CD30 Ab therapy within 4 weeks before enrollment; * Unresolved \> Grade 1 non-hematologic toxicity associated with any prior treatments; * Active uncontrolled bleeding or a known bleeding diathesis; * Autologous hematopoietic stem cell transplantation was performed within 6 weeks; * Uncontrollable active bacterial or fungal infection; * Known allergy to the study drug and its components; * Suffer from active autoimmune diseases that require systemic treatment ; * Persons with mental or mental illness who cannot cooperate with treatment and efficacy evaluation; * Participated in other clinical studies within 1 months prior to this study; * History of allogeneic hematopoietic stem cell transplantation; * patients with any condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject.
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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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Tongji Hospital Affiliated to Tongji Medical College of HUST
RECRUITINGWuhan, Hubei, China
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