Acute Lymphoblastic Leukemia, in RelapsePhase 1/2CARCIKNCT03389035
Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Pediatric and Adult Patients With r/r ALL Post HSCT
A Phase 1/2 study testing CARCIK-CD19 in people with Acute Lymphoblastic Leukemia, in Relapse, 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 1-2a study to determine the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose and the safety of CARCIK-CD19 in adult and pediatric patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Read more about this study
- Who is it for?
- Ages 1 year to 75 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, in Relapse
- What is being tested?
- CARCIK-CD19
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesItaly
- Study dates
- 20 Dec 2017to 30 Dec 2022
- Phase
- Phase 1/2
- 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-cell precursor ALL after HSCT;
- Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry;
- Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening;
- No evidence of overall aGVHD > Grade I or chronic GVHD (cGVHD) greater than mild at time of enrollment and in the previous 30 days;
- No longer taking immunosuppressive agents for at least 30 days prior to enrollment;
Who cannot join
- Patients with GVHD Grades II-IV;
- Any cell therapy in the last 30 days;
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Phase 1-2a Trial to Determine the Feasibility and Safety of a Single Dose of Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Adult and Pediatric Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia, After Hematopoietic Stem Cell Transplantation
This is a single arm, open-label, multi-center, phase 1-2a study to determine the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose and the safety of CARCIK-CD19 in adult and pediatric patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
- Conditions
- Acute Lymphoblastic Leukemia, in Relapse
- Being tested
- CARCIK-CD19
- Keywords
- Acute Lymphoblastic Leukemia, CAR-T, CARCIK, Transposon
- 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.
CARCIK-CD19Biological
Allogeneic (donor-derived) Cytokine Induced Killer (CIK) cells transduced with a transposon CD19 Chimeric Antigen Receptor (CAR) gene
| Study group | Role | What they receive |
|---|---|---|
| CARCIK-CD19 | Experimental | Not described Receives: Biological: CARCIK-CD19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities (DLT):
rate and severity of the cytokine release syndrome (CRS)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start20 Dec 2017
- Primary completion31 Mar 2021
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic Leukemia, in RelapseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
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
- NCT03389035
- Sponsor's protocol ID
- FT01CARCIK
- Acronym
- CARCIK
- Status last verified
- May 2023
- First submitted
- 24 Dec 2017
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Magnani CF, Gaipa G, Lussana F, Belotti D, Gritti G, Napolitano S, Matera G, Cabiati B, Buracchi C, Borleri G, Fazio G, Zaninelli S, Tettamanti S, Cesana S, Colombo V, Quaroni M, Cazzaniga G, Rovelli A, Biagi E, Galimberti S, Calabria A, Benedicenti F, Montini E, Ferrari S, Introna M, Balduzzi A, Valsecchi MG, Dastoli G, Rambaldi A, Biondi A. Sleeping Beauty-engineered CAR T cells achieve antileukemic activity without severe toxicities. J Clin Invest. 2020 Nov 2;130(11):6021-6033. doi: 10.1172/JCI138473.
PubMed 32780725
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
- Phase 1-2a Trial to Determine the Feasibility and Safety of a Single Dose of Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Adult and Pediatric Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia, After Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03389035
- Acronym / sponsor ID
- CARCIK / FT01CARCIK
- Conditions
- Acute Lymphoblastic Leukemia, in Relapse
- Keywords
- Acute Lymphoblastic Leukemia, CAR-T, CARCIK, Transposon
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Fondazione Matilde Tettamanti Menotti De Marchi OnlusUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 3 Jan 2018 (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 1-2a study to determine the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose and the safety of CARCIK-CD19 in adult and pediatric patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CARCIK-CD19 | Experimental | Biological: 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 (6 listed)
- Children (1-17) and adults (18-75 years old);
- Relapsed or refractory adult and pediatric B-cell precursor ALL after HSCT;
- Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry;
- Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening;
- No evidence of overall aGVHD > Grade I or chronic GVHD (cGVHD) greater than mild at time of enrollment and in the previous 30 days;
Key exclusion criteria (2 listed)
- Patients with GVHD Grades II-IV;
- Any cell therapy in the last 30 days;
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 |
|---|---|---|
| CARCIK-CD19Allogeneic (donor-derived) Cytokine Induced Killer (CIK) cells transduced with a transposon CD19 Chimeric Antigen Receptor (CAR) gene | Biological | CARCIK-CD19 |
Primary outcome
Dose Limiting Toxicities (DLT):
Time frame: 1 month
rate and severity of the cytokine release syndrome (CRS)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Derived from this study: PubMed 32780725Magnani CF, Gaipa G, Lussana F, Belotti D, Gritti G, Napolitano S, Matera G, Cabiati B, Buracchi C, Borleri G, Fazio G, Zaninelli S, Tettamanti S, Cesana S, Colombo V, Quaroni M, Cazzaniga G, Rovelli A, Biagi E, Galimberti S, Calabria A, Benedicenti F, Montini E, Ferrari S, Introna M, Balduzzi A, Valsecchi MG, Dastoli G, Rambaldi A, Biondi A. Sleeping Beauty-engineered CAR T cells achieve antileukemic activity without severe toxicities. J Clin Invest. 2020 Nov 2;130(11):6021-6033. doi: 10.1172/JCI138473.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CARCIK-CD19 in people with Acute Lymphoblastic Leukemia, in Relapse, 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 6 inclusion and 2 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: finished, 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicities (DLT): (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03389035, which also lists 1 linked publication.
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.