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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

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