One Trial to Evaluate the Safety, Tolerability and Efficacy of JCXH-213 in Patients With r/r B-NHL
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing GoBroad Hospital
About this trial
Evaluate the Safety and Efficacy of JCXH-213 in Patients with Relapsed/Refractory B-cell non-Hodgkin Lymphoma
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Sequential
Treatments tested in this trial
JCXH-213,an mRNA-LNP based in vivo CAR therapy
DrugJCXH-213 infusion
Treatment groups
8 Participants
are divided into 1 treatment groupGroup A: JCXH-213 experimental groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose limiting toxicity (DLT).
Time frame
The DLT observation period is 21 days after first infusion of JCXH-213.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing GoBroad Hospital
Lead sponsor
Ruijin Hospital
Collaborator
Source ClinicalTrials.gov