ClinicalTrials.gov
ClinicalTrials.gov Menu

Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Pediatric and Adult Patients With r/r ALL Post HSCT (CARCIK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03389035
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Fondazione Matilde Tettamanti Menotti De Marchi Onlus

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.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia, in Relapse Biological: CARCIK-CD19 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 20, 2017
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2020


Arm Intervention/treatment
Experimental: CARCIK-CD19 Biological: CARCIK-CD19
Allogeneic (donor-derived) Cytokine Induced Killer (CIK) cells transduced with a transposon CD19 Chimeric Antigen Receptor (CAR) gene



Primary Outcome Measures :
  1. Dose Limiting Toxicities (DLT): [ Time Frame: 1 month ]
    rate and severity of the cytokine release syndrome (CRS)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   1 Year to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389035


Locations
Italy
Ospedale PG23 Recruiting
Bergamo, BG, Italy, 24127
Contact: Segreteria Ematologia    +39035267 ext 3684    ematologiasegr@asst-pg23.it   
Principal Investigator: Alessandro Rambaldi, Prof.         
Fondazione MBBM Recruiting
Monza, MB, Italy, 20900
Contact: Segreteria Direzione    +39039233 ext 6816    segreteriadirezionecp@fondazionembbm.it   
Principal Investigator: Andrea Biondi, Prof.         
Sponsors and Collaborators
Fondazione Matilde Tettamanti Menotti De Marchi Onlus

Responsible Party: Fondazione Matilde Tettamanti Menotti De Marchi Onlus
ClinicalTrials.gov Identifier: NCT03389035     History of Changes
Other Study ID Numbers: FT01CARCIK
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fondazione Matilde Tettamanti Menotti De Marchi Onlus:
Acute Lymphoblastic Leukemia
CAR-T
CARCIK
Transposon

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases