Trial Outcomes & Findings for Descartes-08 Consolidation Treatment in Patients With High-Risk Multiple Myeloma High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy (NCT NCT04816526)

Last Updated: 2024-10-08

Results Overview

Per IMWG 2016 Response Criteria Summary sCR: Complete response (CR) plus a normal free light chain ratio and no clonal cells in bone marrow (by immunohistochemistry). The FLC ratio must be Kappa/Lambda ≤ 4:1 or ≥ 1:2 after counting at least 100 plasma cells. CR: Negative immunofixation in serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. VGPR: Serum M-protein detectable by immunofixation (not on electrophoresis) or a ≥ 90% reduction in M-protein, with urine M-protein \<100 mg/24 hours. PR: ≥ 50% reduction in serum M-protein and a ≥ 90% reduction in 24-hour urinary M-protein (or to \<200 mg/24 hours). If M-protein is unmeasurable, a ≥ 50% decrease in the difference between involved and uninvolved FLC levels is required. If both M-protein and serum-free light chains are unmeasurable, a ≥ 50% reduction in plasma cells is necessary, provided baseline plasma-cell percentage in bone marrow was ≥ 30%. Overall Response (OR): CR+VGPR+PR

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

8 months

Results posted on

2024-10-08

Participant Flow

Participant milestones

Participant milestones
Measure	Descartes 08 Six IV infusions of Descartes-08 on Days 1, 4, 11, 15, 18 at 30X10\^6 cells/kg.
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Descartes-08 Consolidation Treatment in Patients With High-Risk Multiple Myeloma High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Descartes 08 n=13 Participants Descartes 08: Car T-cells
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
Region of Enrollment Turkey	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 months

Population: All enrolled participants

Outcome measures

Outcome measures
Measure	Descartes 08 n=13 Participants Descartes 08: Car T-cells
Rate of Stringent Complete Response	7 Participants

Adverse Events

Descartes 08

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Descartes 08 n=13 participants at risk Descartes 08: Car T-cells
Immune system disorders Fever	7.7% 1/13 • Number of events 1 • Through study completion, median follow up of 5.6 months with a range of 2-11 months.

Other adverse events

Other adverse events
Measure	Descartes 08 n=13 participants at risk Descartes 08: Car T-cells
Immune system disorders Fever	38.5% 5/13 • Number of events 8 • Through study completion, median follow up of 5.6 months with a range of 2-11 months.
Immune system disorders Chills	7.7% 1/13 • Number of events 2 • Through study completion, median follow up of 5.6 months with a range of 2-11 months.
Blood and lymphatic system disorders Thrombocytopenia	15.4% 2/13 • Number of events 2 • Through study completion, median follow up of 5.6 months with a range of 2-11 months.
Blood and lymphatic system disorders Neutropenia	15.4% 2/13 • Number of events 2 • Through study completion, median follow up of 5.6 months with a range of 2-11 months.
Blood and lymphatic system disorders Anemia	7.7% 1/13 • Number of events 1 • Through study completion, median follow up of 5.6 months with a range of 2-11 months.
Renal and urinary disorders Dehydration	7.7% 1/13 • Number of events 1 • Through study completion, median follow up of 5.6 months with a range of 2-11 months.
Nervous system disorders Headache	7.7% 1/13 • Number of events 1 • Through study completion, median follow up of 5.6 months with a range of 2-11 months.
Gastrointestinal disorders Nausea	7.7% 1/13 • Number of events 1 • Through study completion, median follow up of 5.6 months with a range of 2-11 months.
Musculoskeletal and connective tissue disorders Myalgia	7.7% 1/13 • Number of events 1 • Through study completion, median follow up of 5.6 months with a range of 2-11 months.
Ear and labyrinth disorders dizziness	7.7% 1/13 • Number of events 1 • Through study completion, median follow up of 5.6 months with a range of 2-11 months.

Additional Information

Dr. Milos Miljkovic, Chief Medical Officer

Cartesian Therapeutics

Phone: 4436335855

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place