B-cell non-Hodgkin lymphoma
Conditions
Interventions
JCXH-213 experimental group:JCXH-213 infusion,an mRNA-LNP based in vivo CAR therapy
Sponsors
Bejing GoBroad Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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. 2.Relapsed/refractory large B-cell lymphoma and there is no standard treatment at present, defined as meeting one or more of the following: 1) Definition of relapse: achieving response (PR and CR) after second-line or beyond therapies, and then relapse. 2) Refractory Definition: A) No response to second-line or beyond treatments: PD or SD as best response to last treatment (SD requires at least 2 cycles of treatment). B) Relapse or progression within 12 months after autologous stem cell transplant (ASCT) and received salvage therapy, without response to last therapy (SD or PD). 3.Patients must have received prior adequate therapy including at least: 1) Anti-CD20 monoclonal antibody unless the investigator determines the tumor is CD20 negative. 2) Chemotherapy containing anthracycline. 3) Patients with transformed follicular lymphoma (tFL) who had previously received chemotherapy for follicular lymphoma (FL) presented refractory to chemotherapy with transformation DLBCL. 4. ECOG performance status 0 to 1. 5. 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
Exclusion criteria: 1. 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. 2. B-cell non-Hodgkin lymphoma with active primary or secondary central nervous system involvement. 3. Life expectancy less than 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity (DLT); | — |
Countries
China
Contacts
Public ContactHuKai
Bejing GoBroad Hospital
Outcome results
None listed