NCT06307600

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: All
• Age: 3 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The study completes the enrollment of all evaluable subjects for DLT during the dose escalation phase, followed by DLT observation, and enters a efficacy exploration phase lasting up to 1 year. After safety conclusions are drawn for each group, investigators may choose to expand cases in the corresponding dose group based on treatment response, but the total number of cases should not exceed 12 (expanded cases are not subjected to DLT evaluation).

Conditions

• B Lymphoblastic Leukemia/Lymphoma

Interventions

Type	Name	Description
DRUG	RD06-03 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

Timeline

• Start date: 2024-03-15
• Primary completion: 2025-03-15
• Completion: 2027-04-01
• First posted: 2024-03-13
• Last updated: 2025-01-23

Locations

2 sites across 1 country: China