Trials Sponsors Conditions Drugs Pricing

Conditions

Chimeric Antigen Receptor T-cell Non-hodgkin Lymphoma Refractory Lymphoma

Outcome Measures

Primary Outcomes (1)

Complete remission (CR)
Complete remission rate was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Up to 3 months

Secondary Outcomes (2)

Recurrence free survival time (RFS)
Up to 24 months
Overall survival（OS）
Up to 24 months

Study Arms (4)

Low dose group

EXPERIMENTAL

GB5005 chimeric antigen receptor T-cell injection（1 × 10 \^ 6 cells/kg）

Drug: GB5005 CART

Median dose group

EXPERIMENTAL

GB5005 chimeric antigen receptor T-cell injection（2 × 10 \^ 6 cells/kg）

Drug: GB5005 CART

Medium to high dose group

EXPERIMENTAL

GB5005 chimeric antigen receptor T-cell injection（3 × 10 \^ 6 cells/kg）

Drug: GB5005 CART

Interventions

GB5005 CARTDrug

Included patients will receive GB5005 chimeric antigen receptor T-cell injection: A sterile syringe will be used to draw the assigned dose volume (calculated based on the patient's weight and converted to volume). The cells will be slowly infused intravenously at a rate of about 10 mL/min.

Also known as: GB5005 chimeric antigen receptor T-cell injection

High dose groupLow dose groupMedian dose groupMedium to high dose group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

The candidate is able to communicate effectively with researchers and sign informed consent forms in writing;
Age greater than or equal to 18 years old and less than or equal to 70 years old, regardless of gender; Sign informed consent form;

Sponsors & Collaborators

The First Affiliated Hospital of Xiamen University
Otherlead

Study Sites (1)

Bing Xu

Xiamen, Fujian, 361000, China

RECRUITING

Bing XuCONTACT+8618750918842 xubingzhangjian@126.com

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

Bing Xu
The First Aiffiliated hosptical of xiamen University
PRINCIPAL INVESTIGATOR

Central Study Contacts

Bing Xu

CONTACT

18750918842 xubingzhangjian@126.com

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

March 8, 2025

First Posted

March 13, 2025

Study Start

April 30, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

May 31, 2026

You may not qualify if:

Patients with a history of allergies to serum albumin and DMSO in the past;
Active hepatitis B virus (HBV) (HBV-DNA positive), hepatitis C virus antibody (HCV) (HCV-RNA positive), or human immunodeficiency virus (HIV) infection;
Within the past 2 years, terminal organ damage caused by autoimmune diseases such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, or the need for systemic use of immunosuppressive or other systemic disease control drugs;
History of unstable angina, myocardial infarction, coronary angioplasty, or significant heart disease within one year of enrollment;
Primary central nervous system tumors or hematological tumors with central nervous system metastases;
Uncontrolled mental illness;
Merge other life-threatening severe organ failure;
Participated in other clinical studies within 4 weeks;
Received live vaccination within 4 weeks of enrollment;
Using prohibited drugs: a. Hormones: Corticosteroids (defined as\>20mg/day prednisone or equivalent) used at therapeutic doses within 7 days prior to leukocyte collection. But the use of physiological substitutes, local and inhaled steroids is allowed. b. Chemotherapy: rescue chemotherapy, including tyrosine kinase inhibitors (TKIs), received within 1 week before leukocyte collection. c. Donor lymphocyte infusion (DLI) received within 4 weeks before leukocyte collection. d. graft-versus-host disease (GvHD) treatment: systemic anti GVHD treatment received within 3 months before GB5005 cell infusion. e. Alenumab used within 6 months before leukocyte collection, or chlorofarabin or cladribin used within 3 months. f. Checkpoint inhibitors or stimulants used before enrollment (excluding those with more than 3 biological half lives);
Patients with known history of lung injury or hemorrhagic cystitis associated with cyclophosphamide treatment;
Women who are already pregnant, preparing for pregnancy during the trial period, or breastfeeding;
：As per the investigator's judgment, the subject is unlikely to complete all required visits or procedures stipulated in the protocol (including the follow-up period) or has insufficient compliance with the study.

GB5005 CART-cell Injection in the Treatment of Patients With CD19-positive RR B-NHL

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (4)

Low dose group

Median dose group

Medium to high dose group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

High dose group

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (4)

Low dose group

Median dose group

Medium to high dose group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

High dose group

You may not qualify if:

Data Sharing

Source record

Locations