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
Qualifiers
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
Treatments tested in this trial
- FCTX-CL19-1 (Tarcidomgen Kimleucel)
Treatment groups
6 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov