Trials Sponsors Conditions Drugs Pricing

Conditions

Acute myeloid leukemia and Blastic plasmacytoid dendritic cell neoplasm AML (Acute Myeloid Leukemia)BPDCN

Outcome Measures

Primary Outcomes (1)

Long term survival
12 months from treatment

Study Arms (1)

single arm of patients treated with CARCIK CD123/33

EXPERIMENTAL

Drug: CARCIK CD123/33 infusion

Interventions

CARCIK CD123/33 infusionDrug

split dose of CARCIK cells

single arm of patients treated with CARCIK CD123/33

CARCIK CD123/33Type not reported

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age6 Months - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Patients/ parents or legal representatives able and willing to provide written informed consent and to comply with the study protocol according to ICH and local regulations. Age-appropriate assent from children will also be requested.
Age limits: children (6 months - 17 years old) and adults (≥18 years old - 75 years old)

Sponsors & Collaborators

Fondazione Tettamanti
Type not reportedlead
Fondazione IRCCS San Gerardo Dei Tintori
Type not reportedco_sponsor

Study Sites (2)

Fondazione IRCCS San Gerardo dei Tintori

Monza, MB, 20900, Italy

RECRUITING

Giorgio Ottaviano, MedicineCONTACT039392336881 giorgioantonio.ottaviano@irccs-sangerardo.it

Giovanna Lucchini, MedicineCONTACT039392334915 giovanna.lucchini@irccs-sangerardo.it

Giorgio Antonio Ottaviano, MedicinePRINCIPAL INVESTIGATOR

ASST Papa Giovanni XXIII

Bergamo, 24107, Italy

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteBlastic Plasmacytoid Dendritic Cell Neoplasm

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesHistiocytic Disorders, MalignantLymphomaHematologic NeoplasmsNeoplasms by SiteSkin NeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 8, 2026

First Posted

October 16, 2026

Study Start

October 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

October 2028

Estimated

You may not qualify if:

Patients with clinically significant active viral, bacterial or fungal infection.
Patients with an active infection with Hepatitis B. However, patients with a controlled (treated) hepatitis will be allowed if the all the following criteria are met:
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
Patients with an active hepatitis C virus (HCV) infection. However, patients with successfully treated chronic HCV infection will be allowed if they show a sustained virologic response at 12 weeks (SVR12) or 24 weeks (SVR24), and if there is a 4-week period between achieving sustained viral response (SVR12 or SVR24) and time of informed consent.
HIV Positive test (serology or PCR)
Rapidly progressive disease that in the estimation of the investigator and sponsor could affect compliance with the protocol or interpretation of results
Uncontrollable CNS leukemia or neurological symptoms defined as CNS grade 3. A CNS evaluation should be performed as clinically appropriated to rule out CNS involvement.
Presence of clinically meaningful donor specific anti-HLA antibodies (DSA) against CARCIK-CD123/33 donor haplotype HLA typing
Patients with another active invasive malignancy. Only patients with completely resected carcinoma in situ not requiring treatment other than surgery can be considered for treatment.
Class III/IV cardiovascular disability according to New York Heart Association (NYHA) classification, myocardial infarction or cerebrovascular accident within 30 days prior to Dual CARCIK infusion, unstable arrhythmias, or unstable angina)
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders (bronchospasm, obstructive pulmonary disease) and known autoimmune diseases
Treatment with any other standard anti-cancer radiotherapy/chemotherapy (except hydroxyurea,) including investigational therapy (defined as treatment for which there is currently no regulatory authority approved indication) within 2 weeks prior to Dual CARCIK infusion
Treatment with investigational therapy (defined as treatment for which there is currently no regulatory authority approved indication) 14 days prior to lymphodepletion or five half-life duration of the drug, or whichever comes first
+7 more criteria

CARCIK CD123/33 for Refractory/Relapsed AML and BPDCN in Children and Adults

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

single arm of patients treated with CARCIK CD123/33

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

single arm of patients treated with CARCIK CD123/33

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source records

Locations