Open-label, Multi-center, Phase 1b/2 Clinical Trial to Evaluate the Safety and Efficacy of Autologous CAR-BCMA T-cells (CT053) in Patients

Overview

Información sobre este estudio

The purpose of this study is to evaluate Chimeric Antigen Receptor T Cells targeting BCMA in patients with myeloma.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Voluntarily signed consent.
  • Age of ≥ 18 and ≤ 80 years.
  • Received sufficient prior lines of myeloma therapy.
  • Received treatment with at least one proteasome inhibitor, one IMiD and daratumumab.
  • The patients should have measurable disease per IMWG definition.
  • Estimated life expectancy > 12 weeks.
  • ECOG performance score 0-1.
  • Patients should have reasonable CBC counts, renal and hepatic functions.
  • Sufficient venous access for leukapheresis collection, and no other contraindications to leukapheresis.
  • Women of childbearing age must undergo a serum pregnancy test with negative results before screening, and are willing to use effective and reliable method of contraception for at least 6 months after T cell infusion.
  • Men must be willing to use effective and reliable method of contraception for at least 6 months after T cell infusion.

Exclusion Criteria:

  • Pregnant or lactating women.
  • HIV, active hepatitis C virus (HCV), or active hepatitis B virus (HBV) infection.
  • Any uncontrolled active infection.
  • AEs from previous treatment that have not recovered.
  • Patients who have had anti-BCMA therapy.
  • Patients who have graft versus host disease (GvHD).
  • Patients have received stem cell transplantation less than 12 weeks before leukapheresis.
  • Patients have received any anti-cancer treatment before leukapheresis.
  • Patients have received steroids before leukapheresis or lymphodepletion.
  • Patients have plasma cell leukemia, Waldenström macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome or clinically significant symptomatic immunoglobulin light chain (AL) amyloidosis with evidence of end-organ damage.
  • Patients have been administered live attenuated vaccine before leukapheresis or lymphodepletion.
  • Patients allergic to Flu, Cy, tocilizumab, dimethyl sulfoxide (DMSO) or CT053 CAR BCMA T cell.
  • Patients have clinical significant cardiac conditions that researchers believe that participating in this clinical trial may endanger the health of the patients.
  • Patients have clinical significant pulmonary conditions.
  • Patients are known to have active autoimmune diseases including but not limited to psoriasis, rheumatoid arthritis and other needs of long-term immunosuppressive therapy.
  • Patients with second malignancies in addition to MM are not eligible.
  • Patients have central nervous system (CNS) metastases or CNS involvement.
  • Patients have significant neurologic disorders.
  • Patients are unable or unwilling to comply with the requirements of clinical trial.

Eligibility last updated 11/24/21. Questions regarding updates should be directed to the study team contact.

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Shaji Kumar, M.D.

Comunícate con nosotros para obtener el estatus más reciente

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Saurabh Chhabra, M.B.B.S.

Comunícate con nosotros para obtener el estatus más reciente

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

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More information

Publicaciones

Publications are currently not available

Información adicional de contacto

Formulario de contacto para ensayos sobre cáncer

Teléfono: 855-776-0015 (toll-free)

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