Anti-BCMA chimeric antigen receptor (CARTemis-1) T-lymphocyte therapy in the treatment of patients with multiple myeloma in relapse after allogeneic transplant: EGFR expression as a control mechanism of treatment-derived complications
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase I-II
PATOLOGÍA
Coagulopatías hemorrágicas, Leucemia mieloide aguda, Mieloma Múltiple y otras gammapatías, Terapia celular y T-CARs, Trasplante de progenitores hematopoyéticos, Linfoma
FECHA DE APERTURA
Mayo, 2024
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
1. Patients > 18 years old with a diagnosis of post-allogeneic transplant relapse multiple myeloma. 2. Medical illness 3. Previous treatment with 2 lines before and/or after allogeneic transplant. 4. Patients who are not receiving immunosuppressants at least 1 month before inclusion and who do not have active GVHD. 5. ECOG functional status from 0 to 1. 6. Life expectancy greater than 3 months 7. Patients who give their consent by signing the Informed Consent document.
CRITERIOS DE EXCLUSIÓN
1. Active systemic immunosuppressive therapy. 2. Patients who have previously received CAR-T Anti-BCMA treatment. Patients who have received another type of anti-BCMA therapy will not be excluded, although in this case the positivity for BCMA in myeloma cells must be confirmed at the time of inclusion. 3. Absolute lymphocyte count <0.2x109/L. 4. Previous malignancy, except if in complete remission >3 years, with the exception of cutaneous carcinoma (non-melanoma). 5. Active infection requiring treatment. 6. Active HIV, HBV, or HCV infection. 7. Uncontrolled medical illness. 8. Severe organic disease that meets any of the following criteria: EF <40%, DLCO < 40%, GFR < 50 ml/min, bilirubin > 3 NV (except Gilbert's syndrome). 9. Previous diagnosis of symptomatic AL amyloidosis or POEMS syndrome. 10. Pregnant or lactating women. 11. Women of childbearing potential who are unable or unwilling to use highly effective contraceptive methods 12. Men unable or unwilling to use highly effective contraceptive methods 13. Contraindication to receive lymphodepletive chemotherapy.
DESCRIPCIÓN
Assess the feasibility of generating HUVR-CARTemis-1 and its safety in terms of maximum tolerated dose in patients with multiple myeloma in 1st or successive relapses after allogeneic transplant.
PALABRAS CLAVE
autologous, autologous transplant, bcma, cord blood, donor lymphocyte infusion, factor xi, gene therapy, multiple myeloma, myeloma, ph + acute lymphoblastic leukemia, relapsed/refractory all, umbilical cord blood
