B-Cell Non-Hodgkin Lymphoma-RecurrentNCT06618313
One Trial to Evaluate the Safety, Tolerability and Efficacy of JCXH-213 in Patients With r/r B-NHL
A study testing JCXH-213,an mRNA-LNP based in vivo CAR therapy in people with B-Cell Non-Hodgkin Lymphoma-Recurrent and B-Cell Non-Hodgkin Lymphoma-Refractory, run by Beijing GoBroad Hospital at 1 site in China.
Trial summary
Evaluate the Safety and Efficacy of JCXH-213 in Patients with Relapsed/Refractory B-cell non-Hodgkin Lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-Cell Non-Hodgkin Lymphoma-Recurrent, B-Cell Non-Hodgkin Lymphoma-Refractory
- What is being tested?
- JCXH-213,an mRNA-LNP based in vivo CAR therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2025to Dec 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cytologically or histopathologically confirmed CD19-positive B-cell Hodgkin lymphoma according to WHO 2022 criteria, including but not limited to pathologically confirmed (1) diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS); (2) follicular lymphoma (FL); (3)histologically transformed into diffuse large B-cell lymphoma; (4) primary mediastinal large B-cell lymphoma (PMBCL); (5) High-grade B-cell lymphoma (HGBCL) etc.
- ECOG performance status 0 to 1.
- Existing measurable lesions (Lugano 2014 criteria, as detailed in Appendix 2), meeting one of the following conditions: 1) nodal lesions with a long axis length exceeding 15 mm (short axis length is measurable); 2) extra-nodal lesions with both long axis and short axis lengths exceeding 10 mm.
Who cannot join
- Patients with other malignant tumors within 5 years before screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local radical prostatectomy, radical ductal carcinoma in situ, and radical thyroidectomy.
- B-cell non-Hodgkin lymphoma with active primary or secondary central nervous system involvement.
- Life expectancy less than 3 months.
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
Department of Lymphoma and Myeloma, Yuhengnan Road, Changping District, Beijing
Beijing
Kai Hu, doctor
About this study
Official title: Open-label, Single-arm，Exploratory Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of JCXH-213 in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Evaluate the Safety and Efficacy of JCXH-213 in Patients with Relapsed/Refractory B-cell non-Hodgkin Lymphoma
Read the detailed description
Patient will receive study treatment in the treatment observation period. After the end of the treatment observation period, patients will be allowed to continue to receive treatment if there is no major safety problems and the investigator judges that the patient may continue to benefit.
- Being tested
- JCXH-213,an mRNA-LNP based in vivo CAR therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JCXH-213,an mRNA-LNP based in vivo CAR therapyDrug
JCXH-213 infusion
| Study group | Role | What they receive |
|---|---|---|
| JCXH-213 experimental group | Experimental | 4 dose groups will be set in this part, following the dose escalation pattern (accelerated titration combined with a "3 + 3"). Receives: Drug: JCXH-213,an mRNA-LNP based in vivo CAR therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT).
Measured: The DLT observation period is 21 days after first infusion of JCXH-213.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start27 Mar 2025
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-Cell Non-Hodgkin Lymphoma-RecurrentStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing GoBroad Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital
- Responsible party
- Principal investigator, Kai Hu, Beijing GoBroad Hospital
- Investigators
- Kai Hu, Chief Physician, Principal investigator, Beijing GoBroad Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618313
- Sponsor's protocol ID
- JCXH-213-001
- Status last verified
- May 2025
- First submitted
- 26 Sep 2024
- Last updated
- 3 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Single-arm，Exploratory Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of JCXH-213 in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT06618313
- Acronym / sponsor ID
- JCXH-213-001
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Beijing GoBroad HospitalUniversity, hospital or other
- Collaborators
- Ruijin Hospital
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Oct 2024 (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.
Evaluate the Safety and Efficacy of JCXH-213 in Patients with Relapsed/Refractory B-cell non-Hodgkin Lymphoma
Detailed description
Patient will receive study treatment in the treatment observation period. After the end of the treatment observation period, patients will be allowed to continue to receive treatment if there is no major safety problems and the investigator judges that the patient may continue to benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JCXH-213 experimental group | Experimental | Drug: JCXH-213,an mRNA-LNP based in vivo CAR therapy4 dose groups will be set in this part, following the dose escalation pattern (accelerated titration combined with a "3 + 3"). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cytologically or histopathologically confirmed CD19-positive B-cell Hodgkin lymphoma according to WHO 2022 criteria, including but not limited to pathologically confirmed (1) diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS); (2) follicular lymphoma (FL); (3)histologically transformed into diffuse large B-cell lymphoma; (4) primary mediastinal large B-cell lymphoma (PMBCL); (5) High-grade B-cell lymphoma (HGBCL) etc.
- ECOG performance status 0 to 1.
- Existing measurable lesions (Lugano 2014 criteria, as detailed in Appendix 2), meeting one of the following conditions: 1) nodal lesions with a long axis length exceeding 15 mm (short axis length is measurable); 2) extra-nodal lesions with both long axis and short axis lengths exceeding 10 mm.
Key exclusion criteria (3 listed)
- Patients with other malignant tumors within 5 years before screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local radical prostatectomy, radical ductal carcinoma in situ, and radical thyroidectomy.
- B-cell non-Hodgkin lymphoma with active primary or secondary central nervous system involvement.
- Life expectancy less than 3 months.
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 |
|---|---|---|
| JCXH-213,an mRNA-LNP based in vivo CAR therapyJCXH-213 infusion | Drug | JCXH-213 experimental group |
Primary outcome
Dose limiting toxicity (DLT).
Time frame: The DLT observation period is 21 days after first infusion of JCXH-213.
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 3 Jun 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.
Kai Hu, Chief Physician principal investigator
Beijing GoBroad 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 JCXH-213,an mRNA-LNP based in vivo CAR therapy in people with B-Cell Non-Hodgkin Lymphoma-Recurrent and B-Cell Non-Hodgkin Lymphoma-Refractory, run by Beijing GoBroad 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 3 inclusion and 3 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 3 Jun 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 Kai Hu (+86 15810245863, HK13610956245@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT). (time frame: The DLT observation period is 21 days after first infusion of JCXH-213.). 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 3 Jun 2025.