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

NCT05869279 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2024-05-03

No results posted yet for this study

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.

Conditions

  • B-cell NHL
  • CLL

Interventions

BIOLOGICAL

CARCIK-CD19

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

Sponsors & Collaborators

  • Fondazione Matilde Tettamanti Menotti De Marchi Onlus

    lead OTHER

Principal Investigators

  • Andrea Biondi, MD · IRCCS San Gerardo dei Tintori

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2026-09-01
Completion
2027-09-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05869279 on ClinicalTrials.gov