One Trial to Evaluate the Safety, Tolerability and Efficacy of JCXH-213 in Patients With r/r B-NHL

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06618313

Enrollment

Registered

2024-10-01

Start date

2025-03-27

Completion date

2026-12-31

Last updated

2025-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-Cell Non-Hodgkin Lymphoma-Recurrent, B-Cell Non-Hodgkin Lymphoma-Refractory

Brief summary

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.

Interventions

DRUGJCXH-213,an mRNA-LNP based in vivo CAR therapy

JCXH-213 infusion

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
Dose limiting toxicity (DLT).	The DLT observation period is 21 days after first infusion of JCXH-213.

Countries

China

Contacts

Primary ContactKai Hu

HK13610956245@163.com+86 15810245863

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026