NCT04795882

A New Study Evaluating the Activity of Modular CAR T for mYeloma

An Open Label, Phase 1 Study Evaluating the Activity of Modular CAR T for mYeloma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 rolling 6 trial design evaluating safety of a novel BCMA Chimeric Antigen Receptor (CAR) alone and of CAR T cells engineered to co-express BCMA CAR and a CD19 CAR in patients with relapsed / refractory Multiple Myeloma. The study will assess the feasibility of generating these Advanced Therapy Investigational Products (ATIMPs) and the safety of administering the CAR T cells (either BCMA alone or co-expressed with CD19) in patients with relapsed / refractory multiple myeloma.

Detailed description

This is a Phase 1 rolling 6 trial design evaluating safety of a novel BCMA CAR alone and of CAR T cells engineered to co-express BCMA CAR and a CD19 CAR in patients with triple refractory Multiple Myeloma. The first 3-6 patients will be treated at the lower dose of BCMA CAR T cells in cohort 1 (50 x 10\^6 cells). If the lower dose is deemed tolerable, recruitment into cohort 1 at a higher dose (150 x 10\^6 BCMA CAR T cells) and cohort 2 at a dose of 50 x 10\^6 BCMA/CD19 cells will begin in parallel. * If the 50 x 10\^6 cells BCMA/CD19 CAR dose in cohort 2 is deemed intolerable, then no further patients will be recruited to cohort 2. * If both 150 x 10\^6 cells BCMA CAR (cohort 1) and 50 x 10\^6 cells BCMA/CD19 CAR (cohort 2) are deemed tolerable then recruitment will begin to a higher BCMA/CD19 CAR dose of 150 x 10\^6 cells. * If 150 x 10\^6 cells BCMA CAR is intolerable and 50 x 10\^6 cells BCMA/CD19 CAR is tolerable then no further patients will be recruited to cohorts 1 or 2. With the 150x10\^6 cells dose being deemed tolerable in both cohorts 1 and 2, a dose level 3 of 450x10\^6 CAR T cells has been added to the design via a substantial amendment. Dose level 3 will first open in cohort 1 and, if deemed tolerable, will then proceed to be opened in cohort 2. A Summary of dosing on trial is outlined below: Cohort 1 (BCMA CAR-T cells) * Dose level 1: 50x10\^6 BCMA CAR-T cells * Dose level 2: 150x10\^6 BCMA CAR-T cells * Dose level 3: 450x10\^6 BCMA CAR-T cells administered as a split dose on D0 and D7 (if 1st infusion tolerated well) Cohort 2 (BCMA/CD19 CAR-T cells) * Dose level 1: 50x10\^6 BCMA/CD19 CAR-T cells * Dose level 2: 150x10\^6 BCMA/CD19 CAR-T cells * Dose level 3: 450x10\^6 BCMA/CD19 CAR-T cells administered as a split dose on D0 and D7 (if 1st infusion tolerated well)

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	BCMA CAR T cells	Infusion with ATIMP: BCMA CAR T-cells
BIOLOGICAL	BCMA/CD19 CAR T cells	Infusion with ATIMP: BCMA/CD19 CAR T-cells

Timeline

• Start date: 2022-04-22
• Primary completion: 2029-03-31
• Completion: 2029-03-31
• First posted: 2021-03-12
• Last updated: 2025-11-20

Locations

1 site across 1 country: United Kingdom