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Trial Title:
Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma
NCT ID:
NCT06304636
Condition:
Refractory Multiple Myeloma
Relapsed Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
Relapsed/Refractory
Relapsed Myeloma
Refractory Myeloma
Multiple Myeloma
Car-T
CART
Descartes-15
Descartes
Myeloma
T cells
cell gene
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Descartes-15
Description:
Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA
Arm group label:
Part 1 Descartes-15 with lymphodepletion
Arm group label:
Part 2 Arm 1 Descartes-15 with lymphodepletion
Arm group label:
Part 2 Arm 2 Descartes-15 without lymphodepletion
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
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Center for Cancer and Blood Disorders (AON)
Address:
City:
Bethesda
Zip:
20817
Country:
United States
Status:
Recruiting
Start date:
June 19, 2024
Completion date:
October 1, 2027
Lead sponsor:
Agency:
Cartesian Therapeutics
Agency class:
Industry
Source:
Cartesian Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06304636