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Trial Title:
Safety and Efficacy of CAR T Cell Therapy in Patients with R/r B-ALL
NCT ID:
NCT06635330
Condition:
Relapse/Refractory B-cell Acute Lymphoblastic Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
anti-CD19 CAR T cell therapy
Description:
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).
Arm group label:
Anti-CD19 CAR-T treatment group
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?
Detailed description:
B-cell acute lymphoblastic leukemia (B-ALL), as the most common type of pediatric tumor,
is identified by unregulated cell proliferation of immature lymphoid cells that can
infiltrate the bone marrow and blood. Also, relapse and refractory B-ALL (R/R B-ALL) is
the main reason of global mortality due to the constraints of combination chemotherapy.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Ages 2 to 18 years with relapsed or refractory CD19+ B-ALL
- 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:
- Presence of active malignancy other than the disease under study
- 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
Gender:
All
Minimum age:
2 Years
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Pediatric cell and gene therapy research center, Children medical center
Address:
City:
Tehran
Zip:
1419733151
Country:
Iran, Islamic Republic of
Status:
Recruiting
Contact:
Last name:
Amir Ali Hamidieh
Phone:
+989121593270
Email:
aahamidieh@tums.ac.ir
Start date:
May 20, 2024
Completion date:
September 22, 2027
Lead sponsor:
Agency:
Kara Yakhteh Tajhiz Azma Company
Agency class:
Other
Source:
Kara Yakhteh Tajhiz Azma Company
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06635330
