Trials Sponsors Conditions Drugs Pricing

Conditions

B-Non Hodgkin Lymphoma and Chronic Lymphocytic Leukemia B-cell NHL CLL

Outcome Measures

Primary Outcomes (2)

Dose Limiting Toxicity
Dose Limiting Toxicity
28 day after CARCIK infusion
overall response rate
overall response rate (complete + partial remission)
month 3 after CARCIK-CD19 infusion

Secondary Outcomes (1)

Adverse event (AE)
up to 12 months

Study Arms (1)

CARCIK-CD19

EXPERIMENTAL

Gene therapy product composed of T lymphocytes differentiated according CIK-cell protocol (leading to production of CD3+ cells also expressing CD8 and to a lesser extent CD4 or CD56) that have been genetically modified to express CAR with specificity for targeting CD19 molecule expressed on the surface of B cells. The CARCIK-CD19 contains cells that express the anti-CD19 single chain fragment variable (scFV) linked to an intracellular signaling domain comprising the TCR CD3 ζ chain and tandem costimulatory domains as the CD28 and OX40 (CD19-CD28OX40).

Biological: CARCIK-CD19

Interventions

CARCIK-CD19Biological

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

CARCIK-CD19

PTG-CARCIK-CD19Type not reported

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

Eligibility Criteria

Age1 Year+

Sexall

Healthy VolunteersNo

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

You may qualify if:

criteria apply:
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.

Sponsors & Collaborators

Fondazione Tettamanti
Type not reportedlead
Fondazione Matilde Tettamanti Menotti De Marchi Onlus
Otherlead

Study Sites (1)

Ospedale Papa Giovanni XXIII

Bergamo, BG, 24127, Italy

RECRUITING

Alessandro Rambaldi, MDCONTACTalessandro.rambaldi@unimi.it

Federico Lussana, MDCONTACTflussana@asst-pg23.it

Study Officials

Andrea Biondi, MD
IRCCS San Gerardo dei Tintori
PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Biondi, MD

CONTACT

+39039233 segreteriadirezionecp@fondazionembbm.it

Alessandro Rambaldi, MD

CONTACT

+39035267

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

May 3, 2023

First Posted

May 22, 2023

Study Start

December 1, 2023

Actual (reported)

Primary Completion

September 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

You may not qualify if:

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.
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.
Patients with a positive serologic test or a positive molecular PCR test for human immunodeficiency virus (HIV) are eligible if asymptomatic, well controlled by the HAART therapy and no medically significant active infection is present
Rapidly progressive disease that in the estimation of the investigator and sponsor could affect compliance with the protocol or interpretation of results
Active CNS lymphoma
Major surgery or significant traumatic injury 28 days prior to CARCIK-CD19 infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment
Patients with another active invasive malignancy with a life expectancy of less than 3 years
Significant cardiovascular disease (such as New York Heart Association (NYHA) Class II cardiac disease, congestive heart failure, myocardial infarction or cerebrovascular accident within 30 days prior to CARCIK-CD19 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 including investigational therapy (defined as treatment for which there is currently no regulatory authority approved indication) within 2 weeks prior to CARCIK-CD19 infusion
Allogeneic or autologous Stem Cell Transplantation within 3 months prior to CARCIK-CD19 infusion, or Donor Lymphocytes (DLI)
+5 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (1)

CARCIK-CD19

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (1)

CARCIK-CD19

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations