Transposon-manipulated Allogeneic CARCIK-CD19 cells in Pediatric and Adult Patients with r/r ALL post HSCT

Phase 1

• Conditions: Relapsed or Refractory B cell Acute Lymphoblastic Leukemia after Haematopoietic Stem Cell Transplantation; MedDRA version: 21.0Level: LLTClassification code 10063625Term: Acute lymphoblastic leukemia recurrentSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-000900-38-IT
• Lead Sponsor: FONDAZIONE TETTAMANTI M.DE MARCHI ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-07
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1.Children and adults (1-75 years old);
2.Relapsed or refractory adult and pediatric B-cell precursor ALL after HSCT;
3.Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry;
4.Bone marrow with = 5% lymphoblasts by morphologic assessment at screening ;
5.No evidence of overall aGVHD > Grade I or chronic GVHD (cGVHD) greater than mild at time of enrollment and in the previous 30 days;
6.No longer taking immunosuppressive agents for at least 30 days prior to enrollment;
7.No evidence of concomitant life-threatening infectious disease;
8.Life expectancy > 60 days;
9.Lansky/Karnofsky scores > 60;
10.Absence of severe renal disease (creatinine > x 3 normal for age);
11.Absence of severe hepatic disease (direct bilirubin > 3 mg/dl or SGOT > 500);
12.Patient/guardian able to give informed consent.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

1.Patients with GVHD Grades II-IV;
2.Any cell therapy in the last 30 days;
3.Patient with concomitant life-threatening infectious disease ;
4.Lansky/Karnofsky score <60;
5.Patients with hepatic or renal disease as specific above;
6.Pregnant or breast feeding females;
7.Rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy;
8.Subjects must have recovered from the acute side effects of their prior therapy, such that eligibility criteria are met.;
9.HIV/HBV/HCV Infection: Seropositive for HIV antibody. Seropositive for hepatitis C or positive for Hepatitis B surface antigen (HBsAG);
10.Uncontrolled, symptomatic, intercurrent illness including but not limited to infection, congestive heart failure, unstable angina pectoris and cardiac arrhythmia;
11.Active Central Nervous System (CNS) involvement by malignancy, defined as CNS-3 per National Comprehensive Cancer Network (NCCN) guidelines. Note: Patients with history of CNS disease that has been effectively treated will be eligible
12.Patient has received an investigational medicinal product within the last 30 days prior to screening
13.Pregnant or nursing (lactating) women. NOTE: female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
14.Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) and all male participants, unless they are using highly effective methods of contraception for a period of 1 year after the CARCIK-CD19 infusion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified