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

Acute Lymphoblastic Leukemia, in Relapse Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03389035
• Other study ID #: FT01CARCIK
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 20, 2017
• Est. completion date: December 30, 2022

Study information

• Verified date: May 2023
• Source: Fondazione Matilde Tettamanti Menotti De Marchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 30, 2022
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia, in Relapse
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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

Locations

Country	Name	City	State
Italy	Ospedale PG23	Bergamo	BG
Italy	Fondazione MBBM	Monza	MB

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Matilde Tettamanti Menotti De Marchi Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicities (DLT):	rate and severity of the cytokine release syndrome (CRS)	1 month