LymphomaEarly Phase 1CAR-T，MTDNCT07048353
CD30 CAR-T in the Treatment of CD30 Positive Lymphoma
A Early Phase 1 study testing chimeric antigen receptor gene modified T cells in people with Lymphoma and B Cell Lymphoma, run by Shandong Qilu Cell Therapy Engineering Technology Co., Ltd at 1 site in China.
Trial summary
The is a prospective, open-label, dose-climbing multicenter clinical study assessing the efficacy and safety of CD30 CAR-T in the treatment of r/r CD30+ lymphoma. Plan to recruit 15 subjects with r/r CD30+ lymphoma。 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lymphoma, B Cell Lymphoma, CD30+ Peripheral T-cell Lymphoma
- What is being tested?
- chimeric antigen receptor gene modified T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 28 Jul 2029
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital Affiliated to Tongji Medical College of HUST
Wuhan, Hubei
About this study
Official title: Clinical Study on the Safety and Efficacy of Chimeric Antigen Receptor Gene Modified T Cells Targeting CD30 in the Treatment of CD30 Positive Relapsed/Refractory Lymphoma
The is a prospective, open-label, dose-climbing multicenter clinical study assessing the efficacy and safety of CD30 CAR-T in the treatment of r/r CD30+ lymphoma. Plan to recruit 15 subjects with r/r CD30+ lymphoma。
Read the detailed description
The goal of this clinical trial is to explore the efficacy and safety of CD30 CAR-T on CD30 positive relapsed/refractory lymphoma. The main questions it aims to answer are:
To evaluate the safety and maximum tolerated dose of autologous CD30 CAR-T therapy in CD30-positive relapsed/refractory lymphoma; To evaluate the efficacy of autologous CD30 CAR-T therapy for CD30-positive relapsed/refractory lymphoma; To evaluate the metabolism of CD30 CAR-T cells in vivo; Preliminary evaluation of the correlation between CAR T cell dose and clinical efficacy.
- Conditions
- Lymphoma, B Cell Lymphoma, CD30+ Peripheral T-cell Lymphoma
- Being tested
- chimeric antigen receptor gene modified T cells
- Keywords
- CD30 CAR-T, lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chimeric antigen receptor gene modified T cellsDrug
The rate of intravenous infusion of CD30 CAR T cells was 10 mL to 20 mL/min, and the infusion was performed using a blood transfusion apparatus with a filter screen. Use saline rinsing tube prior to infusion; Rinse the infusion bag with 10 mL~30 mL normal saline.
| Study group | Role | What they receive |
|---|---|---|
| low-dose group | Experimental | Subjects received a single low-dose CD30 CAR-T therapy Receives: Drug: chimeric antigen receptor gene modified T cells |
| medium-dose group | Experimental | Subjects received a single medium-dose CD30 CAR-T therapy Receives: Drug: chimeric antigen receptor gene modified T cells |
| High-dose group | Experimental | Subjects received a single high-dose CD30 CAR-T therapy Receives: Drug: chimeric antigen receptor gene modified T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Incidence of DLTs and occurrence of study related adverse events
Measured: 28 days
Secondary outcomes (3)
Overall response rate
Including complete remission (CR) and partial remission (PR)
Measured: 3,6,12months
Overall Survival
OS was calculated from the first CAR-T cell infusion to death or last follow-up
Measured: 3 years
Progression-free survival
PFS was calculated from the first CAR-T cell infusion to death or rogression of the disease.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start1 Mar 2026
- Primary completion28 Jul 2029 (estimated)
- Study completion28 Jul 2029 (estimated)
Why it stopped: Because of changes in domestic regulations, we need to complete the local filing process first before continuing the research.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Qilu Cell Therapy Engineering Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tongji Hospital Affiliated to Tongji Medical College of HUST, Shanxi Bethune Hospital, Wuhan Central Hospital, Yichang Central People's Hospital, First Affiliated Hospital of Guangxi Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048353
- Sponsor's protocol ID
- ICT-C30-235-1
- Acronym
- CAR-T，MTD
- Status last verified
- Sep 2026
- First submitted
- 24 Jun 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Efficacy of Chimeric Antigen Receptor Gene Modified T Cells Targeting CD30 in the Treatment of CD30 Positive Relapsed/Refractory Lymphoma
- ClinicalTrials.gov ID
- NCT07048353
- Acronym / sponsor ID
- CAR-T，MTD / ICT-C30-235-1
- Conditions
- Lymphoma, B Cell Lymphoma, CD30+ Peripheral T-cell Lymphoma
- Keywords
- CD30 CAR-T, lymphoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Because of changes in domestic regulations, we need to complete the local filing process first before continuing the research.
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shandong Qilu Cell Therapy Engineering Technology Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Tongji Hospital Affiliated to Tongji Medical College of HUST, Shanxi Bethune Hospital, Wuhan Central Hospital, Yichang Central People's Hospital, First Affiliated Hospital of Guangxi Medical University
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 28 Jul 2029 (estimated)
- Study completion
- 28 Jul 2029 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The is a prospective, open-label, dose-climbing multicenter clinical study assessing the efficacy and safety of CD30 CAR-T in the treatment of r/r CD30+ lymphoma. Plan to recruit 15 subjects with r/r CD30+ lymphoma。
Detailed description
The goal of this clinical trial is to explore the efficacy and safety of CD30 CAR-T on CD30 positive relapsed/refractory lymphoma. The main questions it aims to answer are:
To evaluate the safety and maximum tolerated dose of autologous CD30 CAR-T therapy in CD30-positive relapsed/refractory lymphoma; To evaluate the efficacy of autologous CD30 CAR-T therapy for CD30-positive relapsed/refractory lymphoma; To evaluate the metabolism of CD30 CAR-T cells in vivo; Preliminary evaluation of the correlation between CAR T cell dose and clinical efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low-dose group | Experimental | Drug: chimeric antigen receptor gene modified T cellsSubjects received a single low-dose CD30 CAR-T therapy |
| medium-dose group | Experimental | Drug: chimeric antigen receptor gene modified T cellsSubjects received a single medium-dose CD30 CAR-T therapy |
| High-dose group | Experimental | Drug: chimeric antigen receptor gene modified T cellsSubjects received a single high-dose CD30 CAR-T therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chimeric antigen receptor gene modified T cellsThe rate of intravenous infusion of CD30 CAR T cells was 10 mL to 20 mL/min, and the infusion was performed using a blood transfusion apparatus with a filter screen. Use saline rinsing tube prior to infusion; Rinse the infusion bag with 10 mL~30 mL normal saline. | Drug | High-dose group, low-dose group, medium-dose group |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 28 days
Incidence of DLTs and occurrence of study related adverse events
3 secondary outcomes
Overall response rate
Time frame: 3,6,12months
Overall Survival
Time frame: 3 years
Progression-free survival
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing chimeric antigen receptor gene modified T cells in people with Lymphoma and B Cell Lymphoma, run by Shandong Qilu Cell Therapy Engineering Technology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.