Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Pediatric and Adult Patients With r/r ALL Post HSCT
CARCIK
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
1 other identifier
interventional
21
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2017
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 20, 2017
CompletedFirst Submitted
Initial submission to the registry
December 24, 2017
CompletedFirst Posted
Study publicly available on registry
January 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedMay 6, 2023
May 1, 2023
3.3 years
December 24, 2017
May 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dose Limiting Toxicities (DLT):
rate and severity of the cytokine release syndrome (CRS)
1 month
Study Arms (1)
CARCIK-CD19
EXPERIMENTALInterventions
Allogeneic (donor-derived) Cytokine Induced Killer (CIK) cells transduced with a transposon CD19 Chimeric Antigen Receptor (CAR) gene
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- Patients with GVHD Grades II-IV;
- Any cell therapy in the last 30 days;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Ospedale PG23
Bergamo, BG, 24127, Italy
Fondazione MBBM
Monza, MB, 20900, Italy
Related Publications (1)
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.
PMID: 32780725DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 24, 2017
First Posted
January 3, 2018
Study Start
December 20, 2017
Primary Completion
March 31, 2021
Study Completion
December 30, 2022
Last Updated
May 6, 2023
Record last verified: 2023-05