Clinical Trial to Evaluate CT053 in Patients With Relapsed and/or Refractory Multiple Myeloma (LUMMICAR STUDY 2)

Titre officiel

Open Label, Multi-centre, Phase 1b/2 Clinical Trial to Evaluate the Safety and Efficacy of Autologous CAR BCMA T Cells (CT053) in Patients With Relapsed and/or Refractory Multiple Myeloma (LUMMICAR STUDY 2)

Sommaire:

Étude clinique de phase Ib ouverte, multicentrique, portant sur les CAR T-cell (lymphocytes T à récepteur antigénique chimérique) ciblant le CMA (antigène de maturation des lymphocytes B) chez des patients atteints d’un myélome multiple récidivant et/ou réfractaire.

Description de l'essai

Primary Outcome:

• Incidence of Treatment Related adverse events (AEs)
• Identification of Maximum Tolerated Dose (MTD)

Secondary Outcome:

• Evaluate the clinical efficacy of CT053 in patients with rrMM after a single administration of CT053

This is an open label, multi-centre, phase 1b clinical trial to evaluate the safety and efficacy of autologous chimeric antigen receptor-B-cell maturation antigen (CAR-BCMA T cell; CT053) in patients with relapsed and or refractory multiple myeloma. Part A of the study will be Dose Escalation followed by Part B, an expansion cohort. Following consent, enrolled subjects will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (CT053). Following manufacture of the drug product, subjects will receive lymphodepletion prior to CT053 infusion. All subjects who complete the study, as well as those who withdraw from the study after receiving CT053 for reasons other than death or meeting the early termination criteria, will be asked to continue to undergo long-term follow-up in a companion study.

Voir cet essai sur ClinicalTrials.gov