One Trial to Evaluate the Safety, Tolerability and Effica... | NCT06618313

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

NCT06618313

Sponsor

Beijing GoBroad Hospital

Status

Recruiting

Last Update Posted

Jun 3, 2025Actual

Enrollment

8Estimated

Phase

Not Applicable

Conditions

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

Interventions

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

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 27, 2025Actual

Primary Completion Date

Aug 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Sep 26, 2024

First Submission Date that Met QC Criteria

Sep 26, 2024

First Posted Date

Oct 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2025

Last Update Posted Date

Jun 3, 2025Actual

Name	Class
Ruijin Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
JCXH-213,an mRNA-LNP based in vivo CAR therapy	Drug	JCXH-213 infusion	JCXH-213 experimental group

Measure	Description	Time Frame
Dose limiting toxicity (DLT).		The DLT observation period is 21 days after first infusion of JCXH-213.

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kai Hu	Contact	+86 15810245863		HK13610956245@163.com

Overall Officials

Name	Affiliation	Role
Kai Hu, Chief Physician	Beijing GoBroad Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Lymphoma and Myeloma, Yuhengnan Road, Changping District, Beijing	Recruiting	Beijing			China