Acute Lymphoblastic Leukemia (ALL)Phase 1CARLANCT06593145
CAR T Cells in the Treatment of Refractory and Relapsed CD19+ B Cell Neoplasms
A Phase 1 study testing FCTX-CL19-1 (Tarcidomgen Kimleucel) in people with Acute Lymphoblastic Leukemia (ALL) and Mantle Cell Lymphoma (MCL), run by FamiCordTx at 2 sites in Poland.
Trial summary
One arm, open label study to assess the clinical use of Investigational Medicinal Product FCTX-CL19-1 (scientific name: Tarcidomgen Kimleucel) containing autologous anti-CD19 CAR T cells with a preliminary determination of the safety of intravenous IMP administration in patients diagnosed with refractory and relapsed… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia (ALL), Mantle Cell Lymphoma (MCL), Large B-cell Lymphoma
- What is being tested?
- FCTX-CL19-1 (Tarcidomgen Kimleucel)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesPoland
- Study dates
- 24 May 2023to Jun 2025
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients 18-65 both inclusive;
- Diagnosis of:
- Refractory B-ALL (acute lymphocytic leukemia) - relapse after hematopoietic cell transplantation, second or more relapse in patients when transplantation is contraindicated)
- Large B-cell lymphoma including DLBCL NOS, lymphoma with high level of malignancy, follicular lymphoma transformed to DLBCL and primary mediastinal lymphoma - refractory or relapse or after at least 2 lines of systemic treatment)
- Mantle cell lymphoma (MCL) - relapsing or refractory after at least 2 lines of systemic treatment; Diagnostics of individual diagnoses (criteria for complete remission and partial responses for individual disease entities) was developed on the basis of current (July 2022) recommendations of experts of the Polish Society of Clinical Oncology
- Confirmed CD19 expression on malignant cells;
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- General condition measured by ECOG (Eastern Cooperative Oncology Group) ≤ 1;
- Patient's weight between 40 kg - 130 kg
- Sufficient general condition of organs on screening visit:
- ALT/AST <2,5 of UNL and bilirubin <1,5 mg/dl (<4 mg/dl for patients with Gilbert syndrome)
- Ejection fraction (EF) >50% confirmed in ECHO with no signs of exudation in pericardium during 6 weeks before screening
- Saturation of arterial blood >93% with no oxygen insufflation, with no significant exudation in pleural cavity
- Serum creatinine clearance >60 ml/min (by Cockcroft-Gault formula);
- Negative result for HCV, HBV, HIV, Syphilis;
- Negative test for pregnancy (serum or urine) in the screening visit and/or 7 days before leucapheresis and 7 days before lymphodepleting therapy in women in reproductive age;
- Assumption of at least 12 months of survival time from screening visit;
- Agreement to maintain sufficient method of contraception from the date of signing informed consent to 6 months after CART therapy;
- The last dose of SARS-CoV-2 vaccination taken at least 6 months prior to study enrollment
- Capable of providing written informed consent;
- Patients polish native language speaking or fluent in polish language
Who cannot join
- Any significant CNS diseases that preceded and not connected with relapse (including seizures, paresis, aphasia, stroke or CNS bleeding, severe brain trauma, dementia, Parkinson's disease, any disease affecting cerebellum, psychosis and diseases involving lack of coordination or movement);
- Bulky or rapidly progressing disease;
- Less than 3 months after allo-HSCT transplantation or DLI before screening;
- The need for high-dose chemotherapy less than 4 weeks before the scheduled apheresis;
- Concomitant presence of another malignancy and another malignancy diagnosed up to 2 years before inclusion to this trial;
- Patient's weight below 40 kg and above 130kg
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- Any active bacterial, viral or fungal infection including SARS-CoV2;
- Latent HBV/HCV/HIV/Syphilis infection;
- Any other concomitant disease which in the opinion of the investigator would be interfering with the safety of participant in the trial
- Allergic to penicillin, streptomycin and amphotericin B;
- Intolerance to cyclophosphamide or fludarabine during previous treatment with these drugs;
- Chronic systemic immunosuppression treatment (i.e. cyclosporin). Corticosteroids are allowed up to dexamethasone dose of 4 mg a day or equal of this dose;
- Systemic immunosuppression treatment of acute and/or chronic Graft-versus host disease (GvHD) connected to earlier allogeneic HSCT treatment;
- Pregnancy;
- Women in reproductive age as well as men (regardless of age) that do not agree to maintain effective method of contraception during the trial, lactated women can be included into the trial unless declaration of stopping breast feeding during the whole trial time;
- Unable to provide informed consent for this trial;
- Lack of actual vaccination against SARS-CoV2 by vaccine accepted to use in the EU;
- Patients who are not fluent in polish language;
- Previous use of anti-CD19 CART therapy
Trial locations and contacts
2 sites in 1 country.
Poland2 sites, 2 recruiting
- Recruiting
Uniwersyteckie Centrum Kliniczne Gdańskiego Uniwersytetu Medycznego - Katedra i Klinika Hematologii i Transplantologii
Gdansk, Ul. Smoluchowskiego 17, 80-214
A Kolman, akolman@uck.gda.pl
P Kukawka, pkukawka@uck.gda.pl
- Recruiting
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego - Centralny Szpital Kliniczny
Warsaw, Ul. Banacha 1a, 02-097
S Witkowska, +48 780 067 478, samanta.witkowska@op.pl
Grzegorz Basak, Prof
About this study
Official title: Application of the Autologous CAR T Cells (Tarcidomgen Kimleucel) in the Treatment of Refractory and Relapsed CD19+ B Cell Neoplasms
One arm, open label study to assess the clinical use of Investigational Medicinal Product FCTX-CL19-1 (scientific name: Tarcidomgen Kimleucel) containing autologous anti-CD19 CAR T cells with a preliminary determination of the safety of intravenous IMP administration in patients diagnosed with refractory and relapsed CD19 + B cell neoplasms.
Read the detailed description
The aim of the study is to determine the safety of therapy with the study medicinal product FCTX-CL19-1 (Tarcidomgen Kimleucel) with preliminary determination of efficacy, as part of a phase I clinical trial in patients with relapsed and refractory B-cell CD19+ tumors.
The hypothesis of the study assumes that the use of the newly developed product FCTX-CL19-1 (Tarcidomgen Kimleucel) containing autologous anti-CD19 CAR T cells is safe and will lead to remission of B-cell cancer resistant to current treatment.
- Being tested
- FCTX-CL19-1 (Tarcidomgen Kimleucel)
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FCTX-CL19-1 (Tarcidomgen Kimleucel)Biological
It will be administered only by Investigators during hospitalization. Each patient will receive one administration of IMP on Day 0:
- administration route - intravenous
- cell dose: 0,2 x 106 -2 x 106 CAR T cells per kilogram of patient body weight
| Study group | Role | What they receive |
|---|---|---|
| FCTX-CL19-1 (Tarcidomgen Kimleucel) | Experimental | FCTX-CL19-1 (Tarcidomgen Kimleucel) - active IMP - consists of autologous T-cells with chimeric antigen receptor (CAR), Advanced Therapy Medicinal Product, ATMP, Gene Therapy Medicinal Product, GTMP Receives: Biological: FCTX-CL19-1 (Tarcidomgen Kimleucel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with CRS in particular degree of severity according to ASTCT neurological side effects, febrile neutropenia and infection, cytopenia, other unspecified adverse events and death
Safety assessment of IMP administration as the percentage of patients with cytokine release syndrome (CRS) in particular degree of severity according to ASTCT, neurological side effects, febrile neutropenia and infection, cytopenia, other unspecified adverse events and death as a result of the side effects and adverse events described within a 1 month after IMP administration
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Percentage of participants with response to the therapy (sum of complete remissions and partial responses in the particular malignancies)
Percentage of participants with response to the Tarcidomgen Kimleucel, FCTX-CL19-1 therapy ( best overall response rate defined as the sum of complete remissions and partial responses in the particular malignancies) during one month (1 months, 30 days), three months (3 months, 90 days), twelve months (12 months, 360 days) after IMP administration
Measured: through study completion, an average of 1 year
Percentage of participants with no possibility to receive the product due to the production failure
Percentage of participants with no possibility to receive FCTX-CL19-1 (Tarcidomgen Kimleucel) product that meets the assumed quality criteria due to the production failure
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start24 May 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 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 Leukemia (ALL)Studies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FamiCordTx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emilian Snarski, Study director, FamiCordTx S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593145
- Sponsor's protocol ID
- 2021-005720-37
- Acronym
- CARLA
- Status last verified
- Sep 2024
- First submitted
- 2 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the Autologous CAR T Cells (Tarcidomgen Kimleucel) in the Treatment of Refractory and Relapsed CD19+ B Cell Neoplasms
- ClinicalTrials.gov ID
- NCT06593145
- Acronym / sponsor ID
- CARLA / 2021-005720-37
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- FamiCordTxIndustry (pharma, biotech, devices)
- Study start
- 24 May 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
One arm, open label study to assess the clinical use of Investigational Medicinal Product FCTX-CL19-1 (scientific name: Tarcidomgen Kimleucel) containing autologous anti-CD19 CAR T cells with a preliminary determination of the safety of intravenous IMP administration in patients diagnosed with refractory and relapsed CD19 + B cell neoplasms.
Detailed description
The aim of the study is to determine the safety of therapy with the study medicinal product FCTX-CL19-1 (Tarcidomgen Kimleucel) with preliminary determination of efficacy, as part of a phase I clinical trial in patients with relapsed and refractory B-cell CD19+ tumors.
The hypothesis of the study assumes that the use of the newly developed product FCTX-CL19-1 (Tarcidomgen Kimleucel) containing autologous anti-CD19 CAR T cells is safe and will lead to remission of B-cell cancer resistant to current treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FCTX-CL19-1 (Tarcidomgen Kimleucel) | Experimental | Biological: FCTX-CL19-1 (Tarcidomgen Kimleucel)FCTX-CL19-1 (Tarcidomgen Kimleucel) - active IMP - consists of autologous T-cells with chimeric antigen receptor (CAR), Advanced Therapy Medicinal Product, ATMP, Gene Therapy Medicinal Product, GTMP |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Adult patients 18-65 both inclusive;
- Diagnosis of:
- Confirmed CD19 expression on malignant cells;
- General condition measured by ECOG (Eastern Cooperative Oncology Group) ≤ 1;
- Patient's weight between 40 kg - 130 kg
Key exclusion criteria (19 listed)
- Any significant CNS diseases that preceded and not connected with relapse (including seizures, paresis, aphasia, stroke or CNS bleeding, severe brain trauma, dementia, Parkinson's disease, any disease affecting cerebellum, psychosis and diseases involving lack of coordination or movement);
- Bulky or rapidly progressing disease;
- Less than 3 months after allo-HSCT transplantation or DLI before screening;
- The need for high-dose chemotherapy less than 4 weeks before the scheduled apheresis;
- Concomitant presence of another malignancy and another malignancy diagnosed up to 2 years before inclusion to this trial;
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 |
|---|---|---|
| FCTX-CL19-1 (Tarcidomgen Kimleucel)It will be administered only by Investigators during hospitalization. Each patient will receive one administration of IMP on Day 0: * administration route - intravenous * cell dose: 0,2 x 106 -2 x 106 CAR T cells per kilogram of patient body weight | Biological | FCTX-CL19-1 (Tarcidomgen Kimleucel) |
Primary outcome
Percentage of patients with CRS in particular degree of severity according to ASTCT neurological side effects, febrile neutropenia and infection, cytopenia, other unspecified adverse events and death
Time frame: through study completion, an average of 1 year
Safety assessment of IMP administration as the percentage of patients with cytokine release syndrome (CRS) in particular degree of severity according to ASTCT, neurological side effects, febrile neutropenia and infection, cytopenia, other unspecified adverse events and death as a result of the side effects and adverse events described within a 1 month after IMP administration
2 secondary outcomes
Percentage of participants with response to the therapy (sum of complete remissions and partial responses in the particular malignancies)
Time frame: through study completion, an average of 1 year
Percentage of participants with no possibility to receive the product due to the production failure
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
Emilian Snarski study director
FamiCordTx S.A.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FCTX-CL19-1 (Tarcidomgen Kimleucel) in people with Acute Lymphoblastic Leukemia (ALL) and Mantle Cell Lymphoma (MCL), run by FamiCordTx at 2 sites in Poland.
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 20 inclusion and 19 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 19 Sep 2024. 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 Poland. 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 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.
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?
Contact Natalia Żmijewska (+48 795 158 306, n.zmijewska@famicordtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with CRS in particular degree of severity according to ASTCT neurological side effects, febrile neutropenia and infection, cytopenia, other unspecified adverse events and death (time frame: through study completion, an average of 1 year). 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 19 Sep 2024.