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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-27

Study Completion Date

2026-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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JCXH-213 experimental group

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

JCXH-213 infusion

Interventions

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

JCXH-213 infusion

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No