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New treatment option for Acute Lymphoblastic Leukemia (ALL)
Official title CAR T Cells in the Treatment of Refractory and Relapsed CD19+ B Cell Neoplasms
ClinicalTrials.gov ID: NCT06593145
What this study is testing
What is FCTX-CL19-1 (Tarcidomgen Kimleucel)?
FCTX-CL19-1 (Tarcidomgen Kimleucel) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute lymphoblastic leukemia (all).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- Large B-cell lymphoma including DLBCL NOS, lymphoma with high level of malignancy, follicular lymphoma transformed to DLBCL and primary mediastinal...
- Mantle cell lymphoma (MCL) - relapsing or refractory after at least 2 lines of systemic treatment; Diagnostics of individual diagnoses (criteria for...
You likely can't join if
- Any significant CNS diseases that preceded and not connected with relapse (including seizures, paresis, aphasia, stroke or CNS bleeding, severe brain...
- 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
See the full eligibility criteria
- 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...
- 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...
- Confirmed CD19 expression on malignant cells;
- 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
- 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Warsaw, Ul. Banacha 1a, Poland
- Gdansk, Ul. Smoluchowskiego 17, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Warsaw, Ul. Banacha 1a, Poland; Gdansk, Ul. Smoluchowskiego 17, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.