RecruitingEarly Phase 1NCT06890494

Clinical Study on the Safety and Efficacy of BiTE-EV in Relapsed/Refractory Acute B-Cell Leukemia

Clinical Study on the Safety and Efficacy of BiTE-EV Therapy in Relapsed/Refractory Acute B-Cell Lymphoblastic Leukemia

Sponsor

Beijing GoBroad Hospital

Enrollment

3 participants

Start Date

Jan 18, 2025

Study Type

INTERVENTIONAL

Conditions

Leukemia

Summary

The goal of this clinical trial is to learn if BiTE-EV works to treat relapsed/refractory acute B-cell leukemia in adults. It will also learn about the safety of BiTE-EV. The main questions it aims to answer are: Can BiTE-EV effectively treat relapsed/refractory acute B-cell lymphoblastic leukemia? What medical problems do participants have when taking BiTE-EV? Participants will: Take BiTE-EV every other day for 1 or 2 months Keep a diary of their symptoms during the medication period During the follow-up period, visit the clinic once every 4 weeks for checkups and tests

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests BiTE-EV — a type of engineered protein called a bispecific T-cell engager that links immune cells to cancer cells and helps destroy them — in people with relapsed or treatment-resistant acute B-cell leukemia (a fast-growing blood cancer). It is particularly for patients who did not respond to or relapsed after CAR-T therapy or stem cell transplant. **You may be eligible if...** - You have acute B-cell lymphocytic leukemia that relapsed after CAR-T therapy or transplant, is refractory, or your T cells cannot be used to make CAR-T cells - Your cancer cells are CD19-positive on testing - You are between 18 and 70 years old - Your organ function is adequate for treatment **You may NOT be eligible if...** - Your cancer does not express CD19 - You have active infections or serious other medical conditions - You are pregnant or breastfeeding - You have had recent major surgery or radiation 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.

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Interventions

DRUGBiTE-EV

Thi product organically combines extracellular vesicles with BiTEs, and enables stable expression of the bispecific antibody on the surface of mesenchymal stem cells. By collecting the culture supernatant, the bispecific vesicles BiTE-EV, which express both CD3 and CD19 antibodies on their surface, are enriched and isolated.