Lymphoma, B-CellNCT06850285
CD30 CAR-T in the Treatment of CD30 Positive Relapsed/Refractory Lymphoma
A study testing chimeric antigen receptor gene modified T cells in people with Lymphoma, B-Cell, run by Shanxi Bethune Hospital at 1 site in China.
Trial summary
The is a prospective, open-label, dose-climbing 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 15 to 80 years
- Conditions the study is for
- Lymphoma, B-Cell
- 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
- 5 Sep 2025to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age≥15 years and ≤80years，female and male；
- CD30+ lymphocyte malignancies;
- CD30 expression >10% by immunohistochemistry；
- At least 1 measurable lesion can be measured according to theLugano 2014 evaluation criteria;
- Not suitable for autologous hematopoietic stem cell transplantation or recurrence after autologous hematopoietic stem cell transplantation;
- Not suitable for BV treatment or relapse after BV treatment, and the expression of CD30 was confirmed by histology;
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- 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.
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. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanxi Bethune Hospital
Taiyuan, Shangxi
jia wei, 13986102084, jiawei@tjh.tjmu.edu.cn
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 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 effect of CD30 CAR-T on CD30 positive relapsed/refractory lymphoma. The main questions it aims to answer are:
To evaluate the safety 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
- Being tested
- chimeric antigen receptor gene modified T cells
- Keywords
- CD30 CAR-T; lymphoma;
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma
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
Also called CAR-T
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 |
|---|---|---|
| Group1 | Experimental | Subjects received a single low-dose CD30 CAR-T therapy(1*10^6/kg CAR+T cells) Receives: Drug: chimeric antigen receptor gene modified T cells |
| Group2 | Experimental | Subjects received a single low-dose CD30 CAR-T therapy(2*10^6/kg CAR+T cells) Receives: Drug: chimeric antigen receptor gene modified T cells |
| Group3 | Experimental | Subjects received a single low-dose CD30 CAR-T therapy(5*10^6/kg CAR+T cells) 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.
Overall response rate
Including complete remission (CR) and partial remission (PR)
Measured: 6 months
To evaluate safety and dose limiting toxicities (DLT) of autologous CD30 CAR-T and establish the recommended Phase dose
Incidence of DLTs and occurrence of study related adverse events
Measured: 28 days
Secondary outcomes (2)
Disease-free survival
DFS was calculated from the first CAR-T cell infusion to death, progression of the disease, relapse or gene recurrence, whichever came first, or last visit.
Measured: 3years
Overall Survival
OS was calculated from the first CAR-T cell infusion to death or last follow-up
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 posted27 Feb 2025
- Study start5 Sep 2025 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, B-CellStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanxi Bethune Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jia wei, Principal investigator, Shanxi Bethune Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850285
- Sponsor's protocol ID
- ICT-CD30-2311-1
- Status last verified
- Mar 2024
- First submitted
- 23 Feb 2025
- Last updated
- 27 Feb 2025
- 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 27 Feb 2025. 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
- NCT06850285
- Acronym / sponsor ID
- ICT-CD30-2311-1
- Conditions
- Lymphoma, B-Cell
- Keywords
- CD30 CAR-T; lymphoma;
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shanxi Bethune HospitalUniversity, hospital or other
- Study start
- 5 Sep 2025 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 27 Feb 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 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 effect of CD30 CAR-T on CD30 positive relapsed/refractory lymphoma. The main questions it aims to answer are:
To evaluate the safety 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 |
|---|---|---|
| Group1 | Experimental | Drug: chimeric antigen receptor gene modified T cellsSubjects received a single low-dose CD30 CAR-T therapy(1*10^6/kg CAR+T cells) |
| Group2 | Experimental | Drug: chimeric antigen receptor gene modified T cellsSubjects received a single low-dose CD30 CAR-T therapy(2*10^6/kg CAR+T cells) |
| Group3 | Experimental | Drug: chimeric antigen receptor gene modified T cellsSubjects received a single low-dose CD30 CAR-T therapy(5*10^6/kg CAR+T cells) |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Age≥15 years and ≤80years，female and male；
- CD30+ lymphocyte malignancies;
- CD30 expression >10% by immunohistochemistry；
- At least 1 measurable lesion can be measured according to theLugano 2014 evaluation criteria;
- Not suitable for autologous hematopoietic stem cell transplantation or recurrence after autologous hematopoietic stem cell transplantation;
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 cellsAlso: CAR-TThe 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 | Group1, Group2, Group3 |
Primary outcome
Overall response rate
Time frame: 6 months
Including complete remission (CR) and partial remission (PR)
To evaluate safety and dose limiting toxicities (DLT) of autologous CD30 CAR-T and establish the recommended Phase dose
Time frame: 28 days
Incidence of DLTs and occurrence of study related adverse events
2 secondary outcomes
Disease-free survival
Time frame: 3years
Overall Survival
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
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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.
jia wei principal investigator
Shanxi Bethune Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chimeric antigen receptor gene modified T cells in people with Lymphoma, B-Cell, run by Shanxi Bethune Hospital 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 13 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: looking for participants now, as of the sponsor's last update on 27 Feb 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jia wei (13986102084, iawei@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: 6 months). The study lists 2 primary outcomes in all. 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 27 Feb 2025.