MedTrace Logo

Novel Anti-CD19 Universal CAR-T Cells for r/r CD19+ B-ALL

NCT05639179 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-12-08

No results posted yet for this study

Summary

This is a single-arm, single-center, open-labeled clinical study to evaluate the safety and efficacy of UCAR-T Cells injection for patients with relapsed/refractory(r/r) B-cell Acute Lymphoblastic Leukemia(B-ALL).

Conditions

Interventions

BIOLOGICAL

UCAR-T Cells

UCAR-T Cellswill be administered by vein. The trial includes two portions. The first portion is a"3+3"dose escalation study, in which three dose groups are set:Dose level one:1×10\^6 cells/kg;Dose level two:2×10\^6 cells/kg;Dose level three:5×10\^6 cells/kg. Each dose group requires at least three subjects. The trial will start from dose level one. The second portion includes a dosage extended cohort and will start after the finish of the"3+3"dose escalation study. Twelve subjects will get infusion of UCAR-T Cells at the best dose verified in the first portion.

Sponsors & Collaborators

  • 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

    lead OTHER

Principal Investigators

  • Wang Sanbin, Doctor · 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-05
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05639179 on ClinicalTrials.gov