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Safety and Efficacy of CAR T Cell Therapy in Patients with R/r B-ALL

NCT06635330 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-10-10

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety and efficacy of CD19 CAR-T cells in pediatric patients of all genders, aged 2 to 18 years, with relapsing or refractory B cell acute lymphoblastic leukemia (r/r B-ALL). The main questions it aims to answer are as following:

1. What is the percentage of patients with overall remission rate (ORR) of complete response (CR) or complete remission with incomplete blood count recovery (CRi)?
2. What is the rate of Event-free survival at first month and 2-3 months after intervention?
3. What is the rate of Overall survival at first month and at 3 months after the intervention?

Conditions

  • Relapse/Refractory B-cell Acute Lymphoblastic Leukemia

Interventions

BIOLOGICAL

anti-CD19 CAR T cell therapy

Anti-CD19 CAR-T cell therapy for R/R B-ALL pediatric patients. For patients 50 kg and less: 0.2 to 5 in ten to the power of six live CAR+ T cells per kilogram of body weight/ For patients over 50 kg: 0.1 to 2.5 in ten to the power of eight live CAR+ T cells (without considering weight).

Sponsors & Collaborators

  • Kara Yakhteh Tajhiz Azma Company

    lead NETWORK

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-05-20
Primary Completion
2026-09-22
Completion
2027-09-22

Countries

  • Iran

Study Locations

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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 NCT06635330 on ClinicalTrials.gov