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NCT Number: NCT06618313

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Beijing, China

Location status: Recruiting

Location contact

Kai Hu, doctor

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

JCXH-213 infusion

Primary outcomes

  1. Dose limiting toxicity (DLT).

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Beijing GoBroad Hospital

Other

Collaborators

  • Ruijin Hospital

Registry information

Official study title

Open-label, Single-arm,Exploratory Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of JCXH-213 in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 1, 2024
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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