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Residual Disease Driven Strategy for CARCIK (CD19) in Adults/Pediatric BCP-ALL

Primary Purpose

Acute Lymphoblastic Leukemia

Status

Recruiting

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

PTG-CARCIK-CD19

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia focused on measuring ALL

Eligibility Criteria

1 Year - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Children (1-17) and adults (18-75 years old);

Relapsed or refractory adult and pediatric B- ALL as defined for the presence of bone marrow with ≥ 5% lymphoblasts by morphologic assessment, or if <5%, with at least 1% of molecular disease at PCR;
Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry;
Diagnosis of CD19 positive ALL in the bone marrow, and/or peripheral blood and/or extramedullary sites with the exclusion of Central Nervous System (CNS) if CNS-3 disease.

Exclusion Criteria:

GVHD Grades II-IV for patients who had previously been transplanted; 2. Any cell therapy in the previous 30 days;
Patient with concomitant life-threatening infectious disease;
Lansky/Karnofsky score <60;
Patients with hepatic or renal disease as specific above;
Pregnant or breast-feeding females;
Rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy;

Sites / Locations

Ospedale PG23Recruiting
Fondazione MBBMRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CARCIK-CD19

Arm Description

Outcomes

Primary Outcome Measures

To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion

At baseline and at Day 28 after infusion: lymphoblasts < 5% at morphological evaluation of bone marrow aspirate

To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion

At baseline and at Day 28 after infusion: lymphoblasts < 5% at flow cytometry bone marrow evaluation

To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion

At baseline and at Day 28 after infusion: molecular evaluation of disease positivity <0.01%

To evaluate the duration of response of patients treated with CARCIK - CD19 cells. Change from day 28 at month 2, 3, 4, 5, 6, 9 and 12

Day 28 and month 2, 3, 4, 5, 6, 9 and 12: lymphoblasts < 5% at morphological evaluation of bone marrow aspirate

To evaluate the duration of response of patients treated with CARCIK - CD19 cells. Change from day 28 at month 2, 3, 4, 5, 6, 9 and 12

Day 28 and month 2, 3, 4, 5, 6, 9 and 12: lymphoblasts < 5% at flow cytometry bone marrow evaluation

To evaluate the duration of response of patients treated with CARCIK - CD19 cells. Change from day 28 at month 2, 3, 4, 5, 6, 9 and 12

Day 28 and month 2, 3, 4, 5, 6, 9 and 12: molecular evaluation of disease positivity <0.01%

Secondary Outcome Measures

Full Information

NCT ID

NCT05252403

First Posted

January 24, 2022

Last Updated

May 3, 2023

Sponsor

Fondazione Matilde Tettamanti Menotti De Marchi Onlus

1. Study Identification

Unique Protocol Identification Number

NCT05252403

Brief Title

Residual Disease Driven Strategy for CARCIK (CD19) in Adults/Pediatric BCP-ALL

Official Title

Measurable Residual Disease Driven Strategy for One or Two Infusions of Non- Viral, Transposon-manipulated CARCIK (CD19) Cells: A Phase II Study in Pediatric and Adult Patients With Relapsed/Refractory B Cell Precursor ALL (BCP-ALL)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2021 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fondazione Matilde Tettamanti Menotti De Marchi Onlus

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a single arm, open-label, multi-center, phase II study to determine the activity and the safety of a therapeutic strategy that allows a second CARCIK-CD19 cells infusion, driven by the status of disease from one month after the first infusion, in adult and pediatric patients with r/r BCP- ALL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Lymphoblastic Leukemia

Keywords

ALL

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CARCIK-CD19

Arm Type

Experimental

Intervention Type

Genetic

Intervention Name(s)

PTG-CARCIK-CD19

Intervention Description

PTG-CARCIK-CD19 cells is a gene therapy medicinal product (GTMP) composed of genetically modified allogeneic T lymphocytes formulated as cell suspension in normal saline solution and freezing media

Primary Outcome Measure Information:

Title

To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion

Description

At baseline and at Day 28 after infusion: lymphoblasts < 5% at morphological evaluation of bone marrow aspirate

Time Frame

Baseline and day 28

Title

To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion

Description

At baseline and at Day 28 after infusion: lymphoblasts < 5% at flow cytometry bone marrow evaluation

Time Frame

Baseline and day 28

Title

To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion

Description

At baseline and at Day 28 after infusion: molecular evaluation of disease positivity <0.01%

Time Frame

Baseline and day 28

Title

To evaluate the duration of response of patients treated with CARCIK - CD19 cells. Change from day 28 at month 2, 3, 4, 5, 6, 9 and 12

Description

Day 28 and month 2, 3, 4, 5, 6, 9 and 12: lymphoblasts < 5% at morphological evaluation of bone marrow aspirate

Time Frame

Day 28 and month 2, 3, 4, 5, 6, 9 and 12

Title

To evaluate the duration of response of patients treated with CARCIK - CD19 cells. Change from day 28 at month 2, 3, 4, 5, 6, 9 and 12

Description

Day 28 and month 2, 3, 4, 5, 6, 9 and 12: lymphoblasts < 5% at flow cytometry bone marrow evaluation

Time Frame

Day 28 and month 2, 3, 4, 5, 6, 9 and 12

Title

To evaluate the duration of response of patients treated with CARCIK - CD19 cells. Change from day 28 at month 2, 3, 4, 5, 6, 9 and 12

Description

Day 28 and month 2, 3, 4, 5, 6, 9 and 12: molecular evaluation of disease positivity <0.01%

Time Frame

Day 28 and month 2, 3, 4, 5, 6, 9 and 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Children (1-17) and adults (18-75 years old); Relapsed or refractory adult and pediatric B- ALL as defined for the presence of bone marrow with ≥ 5% lymphoblasts by morphologic assessment, or if <5%, with at least 1% of molecular disease at PCR; Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry; Diagnosis of CD19 positive ALL in the bone marrow, and/or peripheral blood and/or extramedullary sites with the exclusion of Central Nervous System (CNS) if CNS-3 disease. Exclusion Criteria: GVHD Grades II-IV for patients who had previously been transplanted; 2. Any cell therapy in the previous 30 days; Patient with concomitant life-threatening infectious disease; Lansky/Karnofsky score <60; Patients with hepatic or renal disease as specific above; Pregnant or breast-feeding females; Rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy;

Facility Information:

Facility Name

Ospedale PG23

City

Bergamo

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alessandroi Rambaldi, MD

Phone

+ 39 035 2673683

arambaldi@asst-pg23.it

Facility Name

Fondazione MBBM

City

Monza

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrea Biondi, MD

Phone

+39 039 2333661

abiondi.unimib@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Residual Disease Driven Strategy for CARCIK (CD19) in Adults/Pediatric BCP-ALL

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