Back to resultsTransposon-manipulated Allogeneic CARCIK-CD19 Cells in Pediatric and Adult Patients With r/r ALL Post HSCT (CARCIK)
Primary Purpose
Acute Lymphoblastic Leukemia, in Relapse
Status
Completed
Phase
Phase 1
Locations
Italy
Study Type
Interventional
Intervention
CARCIK-CD19
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lymphoblastic Leukemia, in Relapse focused on measuring Acute Lymphoblastic Leukemia, CAR-T, CARCIK, Transposon
Eligibility Criteria
Inclusion Criteria:
- Children (1-17) and adults (18-75 years old);
- Relapsed or refractory adult and pediatric B-cell precursor ALL after HSCT;
- Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry;
- Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening;
- No evidence of overall aGVHD > Grade I or chronic GVHD (cGVHD) greater than mild at time of enrollment and in the previous 30 days;
- No longer taking immunosuppressive agents for at least 30 days prior to enrollment;
Exclusion Criteria:
- Patients with GVHD Grades II-IV;
- Any cell therapy in the last 30 days;
Sites / Locations
- Ospedale PG23
- Fondazione MBBM
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CARCIK-CD19
Arm Description
Outcomes
Primary Outcome Measures
Dose Limiting Toxicities (DLT):
rate and severity of the cytokine release syndrome (CRS)
Secondary Outcome Measures
Full Information
NCT ID
NCT03389035
First Posted
December 24, 2017
Last Updated
May 3, 2023
Sponsor
Fondazione Matilde Tettamanti Menotti De Marchi Onlus
1. Study Identification
Unique Protocol Identification Number
NCT03389035
Brief Title
Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Pediatric and Adult Patients With r/r ALL Post HSCT
Acronym
CARCIK
Official Title
Phase 1-2a Trial to Determine the Feasibility and Safety of a Single Dose of Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Adult and Pediatric Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia, After Hematopoietic Stem Cell Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 20, 2017 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
December 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Matilde Tettamanti Menotti De Marchi Onlus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a single arm, open-label, multi-center, phase 1-2a study to determine the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose and the safety of CARCIK-CD19 in adult and pediatric patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia, in Relapse
Keywords
Acute Lymphoblastic Leukemia, CAR-T, CARCIK, Transposon
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CARCIK-CD19
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
CARCIK-CD19
Intervention Description
Allogeneic (donor-derived) Cytokine Induced Killer (CIK) cells transduced with a transposon CD19 Chimeric Antigen Receptor (CAR) gene
Primary Outcome Measure Information:
Title
Dose Limiting Toxicities (DLT):
Description
rate and severity of the cytokine release syndrome (CRS)
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children (1-17) and adults (18-75 years old);
Relapsed or refractory adult and pediatric B-cell precursor ALL after HSCT;
Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry;
Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening;
No evidence of overall aGVHD > Grade I or chronic GVHD (cGVHD) greater than mild at time of enrollment and in the previous 30 days;
No longer taking immunosuppressive agents for at least 30 days prior to enrollment;
Exclusion Criteria:
Patients with GVHD Grades II-IV;
Any cell therapy in the last 30 days;
Facility Information:
Facility Name
Ospedale PG23
City
Bergamo
State/Province
BG
ZIP/Postal Code
24127
Country
Italy
Facility Name
Fondazione MBBM
City
Monza
State/Province
MB
ZIP/Postal Code
20900
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
32780725
Citation
Magnani CF, Gaipa G, Lussana F, Belotti D, Gritti G, Napolitano S, Matera G, Cabiati B, Buracchi C, Borleri G, Fazio G, Zaninelli S, Tettamanti S, Cesana S, Colombo V, Quaroni M, Cazzaniga G, Rovelli A, Biagi E, Galimberti S, Calabria A, Benedicenti F, Montini E, Ferrari S, Introna M, Balduzzi A, Valsecchi MG, Dastoli G, Rambaldi A, Biondi A. Sleeping Beauty-engineered CAR T cells achieve antileukemic activity without severe toxicities. J Clin Invest. 2020 Nov 2;130(11):6021-6033. doi: 10.1172/JCI138473.
Results Reference
derived
Learn more about this trial
Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Pediatric and Adult Patients With r/r ALL Post HSCT
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