RecruitingNot ApplicableNCT06618313
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
Sponsor
Beijing GoBroad Hospital
Enrollment
8 participants
Start Date
Mar 27, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
Evaluate the Safety and Efficacy of JCXH-213 in Patients with Relapsed/Refractory B-cell non-Hodgkin Lymphoma
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- 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 Criteria3
- 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.
Interventions
DRUGJCXH-213,an mRNA-LNP based in vivo CAR therapy
JCXH-213 infusion
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06618313