RecruitingEarly Phase 1NCT06307600

The Safety and Efficacy of RD06-03 CART Cell Injection in Patients With R/R Acute B-lymphoblastic Leukemia

The Safety and Efficacy of RD06-03 CART Cell Injection in Patients With Relapsed or Refractory B-lymphoblastic Leukemia


Sponsor

Anhui Provincial Hospital

Enrollment

9 participants

Start Date

Mar 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is designed to explore the safety and efficacy for patients with relapsed and/or refractory B-cell lymphoblastic leukemia.


Eligibility

Min Age: 3 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests the safety and effectiveness of a CAR-T cell therapy (called RD06-03) — where a patient's own immune cells are genetically engineered to attack leukemia — for people with relapsed or refractory acute B-cell lymphoblastic leukemia (B-ALL), a type of blood cancer. **You may be eligible if...** - You are between 3 and 70 years old - You have been diagnosed with B-cell ALL and your cancer has either relapsed (come back) or did not respond to standard chemotherapy (refractory) - You meet specific criteria for relapse (e.g., cancer returned within 12 months after first remission) or refractory disease (e.g., failed 2 cycles of standard treatment) - Your general health and organ function are adequate **You may NOT be eligible if...** - You are under 3 or over 70 years old - Your leukemia is not the B-cell type - You do not meet the relapsed or refractory criteria - You have serious organ dysfunction or infections that cannot be controlled 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

DRUGRD06-03 cell injection

The patients in this intervention will use RD06-03 cell injection with 3 dose dose 1: 1×10\^5 CAR+ T Cells/kg dose 2: 3×10\^5 CAR+ T Cells/kg dose 3: 5×10\^5 CAR+ T Cells/kg Dosage form: IV injection Frequency of administration:1 time


Locations(2)

Anhui Provincial Hospital

Hefei, Anhui, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

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NCT06307600