Acute Lymphoblastic LeukemiaPhase 2NCT05252403
Residual Disease Driven Strategy for CARCIK (CD19) in Adults/Pediatric BCP-ALL
A Phase 2 study testing PTG-CARCIK-CD19 in people with Acute Lymphoblastic Leukemia, run by Fondazione Matilde Tettamanti Menotti De Marchi Onlus at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 75 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- PTG-CARCIK-CD19
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Dec 2021to Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Ospedale PG23
Bergamo
Alessandroi Rambaldi, MD, + 39 035 2673683, arambaldi@asst-pg23.it
- Recruiting
Fondazione MBBM
Monza
Andrea Biondi, MD, +39 039 2333661, abiondi.unimib@gmail.com
About this study
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)
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.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- PTG-CARCIK-CD19
- Keywords
- ALL
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTG-CARCIK-CD19Genetic
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
| Study group | Role | What they receive |
|---|---|---|
| CARCIK-CD19 | Experimental | Not described Receives: Genetic: PTG-CARCIK-CD19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and day 28
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
Measured: Baseline and day 28
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%
Measured: Baseline and day 28
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
Measured: Day 28 and month 2, 3, 4, 5, 6, 9 and 12
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
Measured: Day 28 and month 2, 3, 4, 5, 6, 9 and 12
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%
Measured: Day 28 and month 2, 3, 4, 5, 6, 9 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Dec 2021
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Matilde Tettamanti Menotti De Marchi Onlus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252403
- Sponsor's protocol ID
- FT03CARCIK
- Status last verified
- May 2023
- First submitted
- 24 Jan 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05252403
- Acronym / sponsor ID
- FT03CARCIK
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- ALL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Fondazione Matilde Tettamanti Menotti De Marchi OnlusUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CARCIK-CD19 | Experimental | Genetic: PTG-CARCIK-CD19 |
Who may qualify
- Ages
- 1 year to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTG-CARCIK-CD19PTG-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 | Genetic | CARCIK-CD19 |
Primary outcome
To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion
Time frame: Baseline and day 28
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
Time frame: Baseline and day 28
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
Time frame: Baseline and day 28
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
Time frame: Day 28 and 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
Time frame: Day 28 and 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
Time frame: Day 28 and 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%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PTG-CARCIK-CD19 in people with Acute Lymphoblastic Leukemia, run by Fondazione Matilde Tettamanti Menotti De Marchi Onlus at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion (time frame: Baseline and day 28). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.