Actively Recruiting
Phase I/II Trial to Determine the in Vivo Engraftment, Safety and Activity of Allogeneic CARCIK-CD19 Cells in Adult and Pediatric Patients with Relapsed/Refractory B-cell NHL or CLL
Led by Fondazione Matilde Tettamanti Menotti De Marchi Onlus · Updated on 2024-05-03
29
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the engraftment, safety, and clinical activity of a new gene therapy called CARCIK-CD19 in both adult and pediatric patients who have relapsed or refractory mature B-cell cancers, including B-cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). This phase I/II, open-label, single-arm, multi-center study focuses on patients who have limited treatment options and are expected to express the CD19 molecule on their cancer cells. The CARCIK-CD19 cells are produced from the blood of a related donor who shares at least half of the genetic markers. The treatment involves infusing participants with allogeneic cytokine-induced killer (CIK) T cells that have been genetically modified to target the CD19 protein found on B cells. These modified cells express a chimeric antigen receptor (CAR) designed to recognize and attack B-cell cancers. The therapy uses a specific CAR construct combining several signaling domains to enhance its activity. The study includes only one treatment group receiving this experimental CARCIK-CD19 therapy. Participants will be closely monitored for safety and treatment effects, including checking for dose-limiting toxicities within 28 days after infusion and assessing overall response three months after treatment. Researchers will also track adverse events for up to 12 months. Patients undergo various clinical assessments, imaging scans, and laboratory tests to evaluate their health status, disease response, and the behavior of the infused cells. The study aims to provide detailed information about how well the therapy works and its safety profile over time.
CONDITIONS
Brief Title
Allogeneic CARCIK-CD19 in Adults/Pediatric B-cell NHL or Chronic Lymphocytic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent and comply with study protocol.
- Not eligible for commercially available CAR-T cell therapies.
- Age 1 year and older (children 1-17 years; adults 18 years and above).
- Availability of at least haploidentical familial donor eligible for blood donation.
- Histologically confirmed mature B-cell neoplasia (including specified B-cell NHL subtypes and CLL).
- Relapsed or refractory after at least two prior treatments with no available options expected to prolong survival.
- At least one measurable target lesion or assessable disease.
- ECOG performance status ≤2 for age ≥16 or Lansky >50 for age <16.
- Adequate cardiac, pulmonary, liver, renal, and bone marrow function.
- Life expectancy greater than 12 weeks.
- Females of childbearing potential must have negative pregnancy test and agree to contraception and abstinence requirements.
- Male subjects must practice abstinence or use condoms for 12 months post-infusion.
You will not qualify if you...
- Active significant infection requiring hospitalization or IV antibiotics within 2 weeks before infusion.
- Active hepatitis B or C infections not controlled or recently treated as specified.
- Positive HIV test unless well controlled and asymptomatic.
- Rapidly progressive disease affecting protocol compliance.
- Active central nervous system lymphoma.
- Major surgery or trauma within 28 days before infusion.
- Other active invasive malignancies with life expectancy less than 3 years.
- Significant cardiovascular disease or uncontrolled concomitant diseases.
- Recent anti-cancer therapy including investigational treatments within 2 weeks.
- Stem cell transplantation within 3 months prior to infusion.
- Active graft-versus-host disease Grades II-IV or extensive chronic GvHD.
- Prior CART therapy within 30 days before study treatment.
- Unresolved toxicities from prior therapies above Grade 1 except specific exceptions.
- Ongoing corticosteroid use above specified doses within 1 week before infusion.
- Live attenuated vaccine within 4 weeks before infusion.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days after CARCIK infusion
Participants receive the CARCIK-CD19 gene therapy to treat relapsed or refractory B-cell NHL or CLL.
1 infusion visit and multiple follow-up visits during the first 28 days
Duration - Up to 12 months
Participants are monitored for safety and response to treatment up to 12 months following infusion.
Regular visits during the 12 months following treatment
Trial Site Locations
Total: 1 location
1
Ospedale Papa Giovanni XXIII
Bergamo, BG, Italy, 24127
Actively Recruiting
Research Team
A
Andrea Biondi, MD
A
Alessandro Rambaldi, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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