Allogeneic CARCIK-CD19 in Adults/Pediatric B-cell NHL or Chronic Lymphocytic Leukemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age1+
SponsorFondazione Matilde Tettamanti Menotti De Marchi Onlus
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Able and willing to provide written informed consent and to comply with the study protocol according to International Conference on Harmonization (ICH) and local regulations.
Ineligibility to commercially available CAR-T cells
Age limits: children (1-17 years old) and adults (≥18 years old)
Availability of an at least haploidentical (i.e. 4/8 HLA matched by allele typing) familial donor willing to and eligible for blood donation
Disqualifiers
Patients with clinically significant active viral, bacterial or fungal infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics (for IV antibiotics this pertains to completion of last course of antibiotic treatment) within 2 weeks prior to CARCIK-CD19 infusion.
Anti-viral therapy for hepatitis B virus (HBV) must be given for at least 1 month prior to time of informed consent;
HBV viral load must be <2000 IU/mL (104 copies/mL) prior to time of informed consent; and
those on active HBV therapy with viral load <2000 IU/mL (104 copies/mL) should stay on the same anti-viral therapy throughout study treatment
Trial design
Design model
Single group
Treatments tested in this trial
CARCIK-CD19
Biological/Vaccineallogeneic cytokine induced killer cells transduced with a transposon CD19-chimeric antigen receptor (CARCIK-CD19) gene
Treatment groups
29 Participants
are divided into 1 treatment groupGroup A: CARCIK-CD19Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose Limiting Toxicity
Dose Limiting Toxicity
Time frame
28 day after CARCIK infusion2
overall response rate
overall response rate (complete + partial remission)
Time frame
month 3 after CARCIK-CD19 infusionSecondary outcomes
1
Adverse event (AE)
Incidence of Adverse event
Time frame
up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov