Refractory Multiple Myeloma, Relapsed Multiple Myeloma
Conditions
Keywords
Relapsed/Refractory, Relapsed Myeloma, Refractory Myeloma, Multiple Myeloma, Car-T, CART, Descartes-15, Descartes, Myeloma, T cells, cell gene
Brief summary
This is a Phase I dose-escalation study to evaluate the safety, tolerability and preliminary efficacy of an autologous BCMA-targeting RNA-engineered CAR T-cell therapy in patients with Relapsed/Refractory Multiple Myeloma. The cell product is referred to as Descartes-15
Interventions
DRUGDescartes-15
Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA
Sponsors
Cartesian Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Study consists of two parts. Part 1 is a single-arm dose escalation study. Part 2 is a dose-expansion study with 2 arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must be 18 years of age or older at the time of enrollment. * Patients must be diagnosed with active and measurable relapsed/refractory multiple myeloma. * Patients must have failed at least 3 prior lines of therapy which must have included an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 drug or biologic. Failure of treatment and measurable myeloma disease are defined as per 2016 IMWG criteria. * Patients must have clinical performance status of ECOG 0-2. * Patients must have adequate vital organ function as defined by: * Hemoglobin ≥8 g/dL * Absolute neutrophil count \> 1000/ mm3 * Platelets \> 50,000/mm3 * ALT/AST levels lower than 3-fold of normal * Creatinine clearance ≥45 mL/min/1.73 m2 * Normal cardiac and pulmonary function * No thromboembolic events in the past 3 months * No heparin allergy or active infection
Exclusion criteria
* Patients who have any active and uncontrolled infection. * Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above 40 mg/day prednisone equivalent). * Patients who have active central nervous system disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the safety of Descartes-15 in patients with relapsed/refractory multiple myeloma (R/R MM) | Day -60 to Month 12 | Results will be descriptive. Safety and tolerability endpoints are adverse events and serious adverse events as proportion of all participants at a given dose level and in the overall study population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the anti-myeloma activity of Descartes-15, as measured by IMWG response criteria and progression-free survival | Day 1 to Month 12 | Efficacy will be assessed by descriptive statistics of treatment response per IMWG criteria. Efficacy endpoints will be reported as proportion of participants achieving Stable Disease (SD), Partial Response (PR), Very Good Partial Response (VGPR), Complete Response (CR) and stringent Complete Response (sCR) as the best response at a given dose level and in the overall study population. |
Countries
United States
Outcome results
None listed