RecruitingPhase 1Phase 2NCT05869279

Allogeneic CARCIK-CD19 in Adults/Pediatric B-cell NHL or Chronic Lymphocytic Leukemia

Phase I/II Trial to Determine the in Vivo Engraftment, Safety and Clinical Activity of Allogeneic CIK Cells Transduced With a Transposon CD19-chimeric Antigen Receptor (CARCIK-CD19) Gene in Adult and Pediatric Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma


Sponsor

Fondazione Matilde Tettamanti Menotti De Marchi Onlus

Enrollment

29 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single arm, open-label, multi-center, phase I/II study to determine the engraftment, safety and clinical activity of allogeneic CARCIK-CD19 cells in adult and pediatric patients with relapsed/refractory mature B-cell neoplasia expected to express CD19 i.e. B-cell NHL and CLL. CARCIK-CD19 will be produced from the peripheral blood of an at least haploidentical familial donor.


Eligibility

Min Age: 1 Year

Plain Language Summary

Simplified for easier understanding

This study is testing a CAR-T cell therapy called CARCIK-CD19 — where immune cells from a family member are engineered to attack cancer — in children and adults with B-cell blood cancers (including certain lymphomas and chronic lymphocytic leukaemia) who are not eligible for commercially available CAR-T treatments. **You may be eligible if...** - You are between 1 and 17 years old (child) or 18 years or older (adult) - You have been diagnosed with a mature B-cell blood cancer (NHL or CLL) confirmed by biopsy - You are not eligible for commercially available CAR-T cell therapies - You have a family member who is a partial or full HLA tissue match and willing to donate blood **You may NOT be eligible if...** - You are eligible for and willing to receive commercial CAR-T therapy - No suitable family donor is available - You have certain serious infections or organ problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCARCIK-CD19

allogeneic cytokine induced killer cells transduced with a transposon CD19-chimeric antigen receptor (CARCIK-CD19) gene


Locations(1)

Ospedale Papa Giovanni XXIII

Bergamo, BG, Italy

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NCT05869279


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