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Trial Title:
One Trial to Evaluate the Safety, Tolerability and Efficacy of JCXH-213 in Patients With r/r B-NHL
NCT ID:
NCT06618313
Condition:
B-Cell Non-Hodgkin Lymphoma-Recurrent
B-Cell Non-Hodgkin Lymphoma-Refractory
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JCXH-213,an mRNA-LNP based in vivo CAR therapy
Description:
JCXH-213 infusion
Arm group label:
JCXH-213 experimental group
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.
Criteria for eligibility:
Criteria:
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) follicular lymphoma with diffuse large B-cell
transformation; (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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
December 2024
Completion date:
December 2026
Lead sponsor:
Agency:
Beijing GoBroad Hospital
Agency class:
Other
Source:
Beijing GoBroad Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06618313
