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

NCT06618313 | Recruiting

• 1 other identifier: JCXH-213-001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Dose limiting toxicity (DLT).

  The DLT observation period is 21 days after first infusion of JCXH-213.

Study Arms (1)

JCXH-213 experimental group

EXPERIMENTAL

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

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

Interventions

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

JCXH-213 infusion

JCXH-213 experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing GoBroad Hospital: lead
• Ruijin Hospital: collaborator

Study Sites (1)

Department of Lymphoma and Myeloma, Yuhengnan Road, Changping District, Beijing

Beijing, China

RECRUITING

Study Officials

• Kai Hu, Chief Physician

  Beijing GoBroad Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai Hu

CONTACT

+86 15810245863; HK13610956245@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: March 27, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

CN (1)