CD19 Targeted CAR T Cell Therapy in Patients With Relapsed/ Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)
NCT ID: NCT04653493
Last Updated: 2021-03-19
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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UNKNOWN
PHASE1
22 participants
INTERVENTIONAL
2021-08-31
2024-08-31
Brief Summary
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Detailed Description
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Eligible patients will receive CAR T product intravenously as a single or split dose following pre-conditioning by a lymphodepleting chemotherapeutic regimen and will then enter a 30-day follow-up period to monitor adverse events using the NCI CTCAE (version 5.0).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CD19 CAR-T cells
Pediatric or adolescent/young adult patients with CD19+ relapsed or refractory B cell acute lymphoblastic leukemia (R/R B-ALL)
CD19 CAR engineered autologous T-cells
Given IV
Following preconditioning with lymphodepleting chemotherapy (cyclophosphamide and fludarabine) patients will be treated with CD19 Chimeric Antigen Receptor (CAR) T cells as a single or split dose (day 0, 1 and 2, CAR cells will be intravenously infused at the 10%, 30% and 60% ratio respectively). Dosing of CD19 CAR-T cells will follow a dose-escalation schema, with dose changes based on dose-limiting toxicities.
Cyclophosphamide
Given IV
Fludarabine
Given IV
Mesna
Given IV
Interventions
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CD19 CAR engineered autologous T-cells
Given IV
Following preconditioning with lymphodepleting chemotherapy (cyclophosphamide and fludarabine) patients will be treated with CD19 Chimeric Antigen Receptor (CAR) T cells as a single or split dose (day 0, 1 and 2, CAR cells will be intravenously infused at the 10%, 30% and 60% ratio respectively). Dosing of CD19 CAR-T cells will follow a dose-escalation schema, with dose changes based on dose-limiting toxicities.
Cyclophosphamide
Given IV
Fludarabine
Given IV
Mesna
Given IV
Eligibility Criteria
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Inclusion Criteria
1. Relapsed or Refractory CD19 positive B-cell acute lymphoblastic leukemia (R/R B-ALL) A. Primary refractory disease despite at least 2 cycles of an intensive chemotherapy regimen designed to induce remission B. Refractory disease despite salvage therapy C. 2nd or greater relapse D. Any relapse after allogeneic hematopoietic stem cell transplantation
2. Informed consent explained to and signed by patient/parents or legal guardian.
3. The Karnofsky (age ≥10 years)/Lansky (age \<10 years) performance status score over 50 points.
4. Expected to survive for more than 3 months.
5. Patients with a history of prior allogeneic hematopoietic stem cell transplant (HSCT) must be at least 3 months from HSCT at the time of CD19 CAR-T cells infusion and also have not received a donor lymphocyte infusion (DLI) within the 28 days prior to apheresis.
6. Important organ function is satisfied: Heart ultrasound indicates cardiac ejection fraction ≥ 50%, no obvious abnormality in ECG; Adequate pulmonary function defined as forced vital capacity (FVC) ≥ 50% of predicted value; or pulse oximetry ≥ 92% on room air if the patient is unable to perform pulmonary function testing; creatinine clearance calculated by Cockcroft-Gault formula ≥ 50 ml/min/1.73m2; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 times the upper limit of normal for age; Total Bilirubin ≤ 3 times the upper limit of normal for age.
7. Absolute lymphocyte count ≥ 0.5 x 10⁹/L.
8. Hemoglobin ≥ 8 g/dl (can be transfused).
9. Platelet count ≥ 20,000/μL (can be transfused).
10. Meets eligibility criteria to undergo autologous apheresis.
Exclusion Criteria
2. Active CNS involvement of ALL (CNS Grade 3 per National Comprehensive Cancer Network guidelines).
3. Severe, uncontrolled bacterial, fungal or viral infections (Active hepatitis B or C, history of HIV infection)
4. Pre-existing significant neurological disorder.
5. Active significant acute graft versus host disease (GVHD) or moderate/severe chronic GVHD requiring systemic steroids or other immunosuppressants within 4 weeks of enrolment.
6. Pregnant or lactating female.
7. The patient did not agree to use effective contraception during the treatment period and for the following 1 year.
8. A history of other malignant tumors.
9. Receiving systemic steroids therapy exceeding the equivalent of 0.5 mg/ kg/day of methylprednisolone, in the 7 days prior to CAR T-cell infusion
10. Receiving systemic immunosuppressive therapy in the 14 days prior to CAR T-cell infusion
11. Receiving intrathecal chemotherapy in the 7 days prior to CAR T-cell infusion
25 Years
ALL
No
Sponsors
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Gene Therapy Research Center, Shariati Hospital, Tehran University of Medical Sciences, Iran
UNKNOWN
Research Institute for Oncology- Hematology and Cell Therapy (RIOHCT), Tehran University of Medical Sciences, Iran
UNKNOWN
Sabz Biomedicals
INDUSTRY
Responsible Party
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Principal Investigators
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Tahereh Rostami, M.D
Role: PRINCIPAL_INVESTIGATOR
Research Institute for Oncology- Hematology and Cell Therapy (RIOHCT), Tehran University of Medical Sciences, Tehran, Iran
Naser Ahmadbeigi, PhD
Role: STUDY_DIRECTOR
Gene Therapy Research Center, Shariati hospital, Tehran University of Medical Sciences, Tehran, Iran
Locations
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Gene therapy research center, Shariati hospital, Tehran university of medical sciences, Iran
Tehran, , Iran
Research Institute for Oncology- Hematology and Cell Therapy (RIOHCT), Tehran University of Medical Sciences
Tehran, , Iran
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CD19 CAR T Cells for R/R ALL
Identifier Type: -
Identifier Source: org_study_id
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