Safety and Efficacy of CAR T Cell Therapy in Patients with R/r B-ALL
NCT ID: NCT06635330
Last Updated: 2024-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
5 participants
INTERVENTIONAL
2024-05-20
2027-09-22
Brief Summary
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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?
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Detailed Description
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Over the past few years, substantial advancements have been made in treatment of ALL, specifically in the R/R context. Chimeric antigen receptor T (CAR-T) cells are a type of cancer immunotherapy treatment that function through modification of patient T cells to express CAR antigen on their surface. CAR-T cells aimed at CD19 have demonstrated promising activity in treatment of r/r B-ALL. In this study we aim to evaluate safety and efficacy of Anti-CD19 CAR T cell therapy in children with R/R B-ALL.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Anti-CD19 CAR-T treatment group
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* Presence of disease in the bone marrow
* Able to tolerate the apheresis process
* Life expectancy \> 12 weeks
* Lansky or Karnofsky score \> 50%
* At least 7 days passed since the last chemotherapy and the last treatment with corticosteroids
* Informed consent
* Having potential donor for stem cell transplantation
Exclusion Criteria
* Chloroma and leukemic infiltration on MRI or significant neurological symptoms
* Any CNS disorder
* Presence of active GVHD
* Radiation therapy within last 14 days
* History of Anti-CD19 or Anti-CD20 therapy
* Donor lymphocyte injection or other cell therapy methods within the last 30 days
* Presence of severe active infection
* Organ dysfunction
2 Years
18 Years
ALL
No
Sponsors
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Kara Yakhteh Tajhiz Azma Company
NETWORK
Responsible Party
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Locations
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Pediatric cell and gene therapy research center, Children medical center
Tehran, Tehran Province, Iran
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IR.NREC.1403.003
Identifier Type: -
Identifier Source: org_study_id
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