CAR T Cells in the Treatment of Refractory and Relapsed CD19+ B Cell Neoplasms
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFamiCordTx
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients 18-65 both inclusive;
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
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
FCTX-CL19-1 (Tarcidomgen Kimleucel)
Biological/VaccineIt 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
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: FCTX-CL19-1 (Tarcidomgen Kimleucel)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
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
Time frame
through study completion, an average of 1 year2
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
Time frame
through study completion, an average of 1 year Source ClinicalTrials.gov