RecruitingNot ApplicableNCT06940960

JY231(JY231) Injection for the Treatment of Relapsed/Refractory B Cell Lymphoma/ Leukemia

An Early Exploratory Clinical Study on the Safety, Tolerability and Preliminary Efficacy of JY231 Injection in the Treatment of Relapsed or Refractory B-Cell Lymphoma/Leukemia

Sponsor

Affiliated Hospital of Guangdong Medical University

Enrollment

20 participants

Start Date

May 30, 2025

Study Type

INTERVENTIONAL

Conditions

B Acute Lymphoblastic Leukemia B-Non Hodgkin Lymphoma

Summary

This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B cell lymphoma / leukemia. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B cell lymphoma / leukemia.

Eligibility

Min Age: 12 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing JY231, a CAR-T cell therapy (immune cells engineered to fight cancer) that targets a protein called CD19, for patients with B-cell lymphoma or B-cell leukemia that has returned or stopped responding to other treatments. **You may be eligible if...** - You are aged 12–75 - You have B-cell lymphoma (such as DLBCL, follicular lymphoma) or B-cell leukemia (B-ALL) that has relapsed or not responded to prior treatments - Your cancer cells test positive for the CD19 protein - You have not achieved remission after prior chemotherapy or your cancer came back **You may NOT be eligible if...** - You have active central nervous system involvement by lymphoma/leukemia - You have severe organ problems (heart, liver, kidneys, lungs) - You have active serious infections (HIV, hepatitis B/C) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGJY231 Injection

This is an open-label, single-arm study to evaluate the efficacy and safety of in vivo Chimeric Antigen Receptor T-Cell (CAR-T) therapy in patients with relapsed refractory B-cell lymphoma/ leukemia. Upon enrollment, subjects will receive an intravenous infusion of the JY231 preparation. Following the infusion, subjects will be hospitalized for one month for observation, and subjects will be evaluated for safety and efficacy. Subjects will be followed for up to 2 years to determine if the disease is under control.

Locations(1)

Affiliated Hospital of Guangdong Medical University

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06940960

Related Trials

A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)

NCT06124157144 locations

Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia

NCT06317662108 locations

Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia

NCT03150693461 locations

Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy

NCT03959085230 locations

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies

NCT054425151 location