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

Beijing GoBroad Hospital

Status: Enrolling

Conditions: B-Cell Non-Hodgkin Lymphoma-Recurrent; B-Cell Non-Hodgkin Lymphoma-Refractory

Treatments: Drug: JCXH-213,an mRNA-LNP based in vivo CAR therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06618313

JCXH-213-001

Details and patient eligibility

About

Evaluate the Safety and Efficacy of JCXH-213 in Patients with Relapsed/Refractory B-cell non-Hodgkin Lymphoma

Full 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.

Enrollment: 8 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

---

8 participants in 1 patient group

JCXH-213 experimental group

Experimental group

Description:

4 dose groups will be set in this part, following the dose escalation pattern (accelerated titration combined with a "3 + 3").

Treatment:

Drug: JCXH-213,an mRNA-LNP based in vivo CAR therapy