Actively Recruiting
Allogeneic CARCIK-CD19 in Adults/Pediatric B-cell NHL or Chronic Lymphocytic Leukemia
Led by Fondazione Matilde Tettamanti Menotti De Marchi Onlus · Updated on 2024-05-03
29
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 the study protocol
- Ineligible for commercially available CAR-T cell therapies
- Children aged 1 to 17 years and adults aged 18 years or older
- Availability of an at least haploidentical familial donor (4/8 HLA match) eligible for blood donation
- Histologically confirmed mature B-cell neoplasia including indolent or aggressive NHL, CLL, or lymphocytic lymphoma according to WHO 2021 classification
- Relapsed or refractory after at least two prior treatment lines with no available treatments expected to prolong survival or refusal of such treatments
- At least one measurable target lesion by CT scan or assessable disease in bone marrow or spleen
- ECOG performance status 2 or less for those 16 years or older; Lansky score above 50 for those under 16 years
- Adequate cardiac and pulmonary function (ejection fraction over 40% and oxygen saturation over 92%)
- Life expectancy over 12 weeks
- Adequate liver function with bilirubin and liver enzymes within defined limits
- Adequate bone marrow function to receive lymphodepleting chemotherapy
- Adequate renal function (creatinine ≤1.5x ULN or creatinine clearance ≥50 mL/min for adults)
- Females of childbearing potential must have a negative pregnancy test, commit to effective contraception or abstinence, and agree to avoid breastfeeding during the study and for 12 months after infusion
- Male subjects must practice abstinence or use condoms with females of childbearing potential for 12 months after infusion
You will not qualify if you...
- Active or recent significant infection requiring hospitalization or IV antibiotics within 2 weeks prior to infusion
- Active Hepatitis B infection unless controlled with therapy and low viral load
- Active Hepatitis C infection unless successfully treated and sustained virologic response achieved
- Positive HIV test with symptomatic disease or medically significant active infection
- Rapidly progressive disease affecting protocol compliance
- Active central nervous system lymphoma
- Major surgery or significant injury within 28 days prior to infusion
- Another active invasive malignancy with life expectancy less than 3 years
- Significant cardiovascular disease including recent myocardial infarction or unstable conditions
- Uncontrolled concomitant diseases such as diabetes, pulmonary disorders, or autoimmune diseases
- Treatment with other anti-cancer therapies within 2 weeks prior to infusion
- Stem cell transplantation or donor lymphocyte infusion within 3 months prior to infusion
- Active graft-versus-host disease Grades II-IV or extensive chronic GvHD
- Prior CAR-T cell therapy within 30 days before study treatment
- Unresolved toxicities from prior anti-cancer therapy above Grade 1 except specified exceptions
- Use of corticosteroids above defined doses within 1 week prior to infusion
- Administration of live attenuated vaccines within 4 weeks prior to infusion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ospedale Papa Giovanni XXIII
Bergamo, BG, Italy, 24127
Actively Recruiting
Research Team
A
Andrea Biondi, MD
CONTACT
A
Alessandro Rambaldi, MD
CONTACT
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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