Trial Outcomes & Findings for Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma (NCT NCT03994705)

NCT ID: NCT03994705

Last Updated: 2025-05-15

Results Overview

Determine the safety of Descartes-11 in patients with relapsed/refractory multiple myeloma

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 20 participants
• Primary outcome timeframe: Time Frame: 21 days
• Results posted on: 2025-05-15

Participant Flow

Participant milestones

Measure	Decartes-11 Dose Level 1 Participants were administered 10 million cells of Descartes-11 via intravenous catheter on Days 7, 14 Participants were administered cyclophosphamide and Fludarabine on Days 1,2,3	Descates-11 Level 2 Participants were administered cyclophosphamide and Fludarabine for pre-conitioning on Days 1,2,3 Participants were administered 32 million cells of Descartes-11 via intravenous catheter on Days 7, 14	Descartes-11 Dose Level 3 Participants were administered cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 100 million cells of Descartes- 11 on Days 7,14	Descartes-11 Dose Level 4A Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7, 14,21	Descartes-11 Dose Level 4B Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,10,14,17	Descartes-11 Dose Level 4C Participant did not receive preconditioning with cyclophosphamide or fludarabine, Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 1,4,7,10,14,17
Overall Study STARTED	3	4	3	2	4	4
Overall Study COMPLETED	3	4	3	2	4	4
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma

Baseline characteristics by cohort

Measure	Level 1 Dose n=3 Participants 10 x 10\^6 cells / kg	Level 2 Dose n=4 Participants 32 x 10\^6 cells / kg	Level 3 Dose n=3 Participants 100 x 10\^6 cells / kg	Level 4A n=2 Participants 150 x 10\^6 cells / kg	Level 4B n=4 Participants 150 x 10\^6 cells / kg	Level 4C n=4 Participants 150 x 10\^6 cells / kg	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	8 Participants n=8 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=8 Participants	12 Participants n=8 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	7 Participants n=8 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=8 Participants	13 Participants n=8 Participants
Race/Ethnicity, Customized White	3 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	2 participants n=4 Participants	4 participants n=21 Participants	2 participants n=8 Participants	16 participants n=8 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	1 participants n=8 Participants
Race/Ethnicity, Customized Other-Non Hispanic	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	1 participants n=8 Participants	1 participants n=8 Participants
Race/Ethnicity, Customized White (Hispanic)	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	2 participants n=8 Participants	2 participants n=8 Participants
Region of Enrollment United States	3 participants n=5 Participants	4 participants n=7 Participants	3 participants n=5 Participants	2 participants n=4 Participants	4 participants n=21 Participants	4 participants n=8 Participants	20 participants n=8 Participants

PRIMARY outcome

Timeframe: Time Frame: 21 days

Population: Participants with treatment related adverse event

Determine the safety of Descartes-11 in patients with relapsed/refractory multiple myeloma

Outcome measures

Measure	Dose-Escalation Level 1 n=3 Participants Participants were administered Cyclophosphamide and Fludarabine for preconditioning Participants were administered 10 million cells of Descartes-11 via intravenous catheter	Dose Level 2 n=4 Participants Participants were administered Cyclophosphamide and Fludarabine for preconditioning Participants were administered 32 million cells of Descartes-11 via intravenous catheter	Dose Level 3 n=3 Participants Participants were administered Cyclophosphamide and Fludarabine for preconditioning Participants were administered 100 million cells of Descartes-11 via intravenous catheter	Dose Level 4A n=2 Participants Participants were administered Cyclophosphamide and Fludarabine for preconditioning Participants were administered 150 million cells of Descartes-11 via intravenous catheter	Dose Level 4B n=4 Participants Participants were administered Cyclophosphamide and Fludarabine for preconditioning Participants were administered 150 million cells of Descartes-11 via intravenous catheter	Dose Level 4C n=4 Participants Participants were not administered Cyclophosphamide and Fludarabine for preconditioning Participants were administered 100 million cells of Descartes-11 via intravenous catheter
Number of Participants With Treatment-Related Adverse Events	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Disease assessment is on Day 21 (or at least 14 days after first Descartes-11 infusion)

Patience with Complete response (CR) according to the International Myeloma Working Group (IMWG).

Outcome measures

Measure	Dose-Escalation Level 1 n=3 Participants Participants were administered Cyclophosphamide and Fludarabine for preconditioning Participants were administered 10 million cells of Descartes-11 via intravenous catheter	Dose Level 2 n=4 Participants Participants were administered Cyclophosphamide and Fludarabine for preconditioning Participants were administered 32 million cells of Descartes-11 via intravenous catheter	Dose Level 3 n=3 Participants Participants were administered Cyclophosphamide and Fludarabine for preconditioning Participants were administered 100 million cells of Descartes-11 via intravenous catheter	Dose Level 4A n=2 Participants Participants were administered Cyclophosphamide and Fludarabine for preconditioning Participants were administered 150 million cells of Descartes-11 via intravenous catheter	Dose Level 4B n=4 Participants Participants were administered Cyclophosphamide and Fludarabine for preconditioning Participants were administered 150 million cells of Descartes-11 via intravenous catheter	Dose Level 4C n=4 Participants Participants were not administered Cyclophosphamide and Fludarabine for preconditioning Participants were administered 100 million cells of Descartes-11 via intravenous catheter
Disease Assessment Based on International Myeloma Working Group (IMWG) Criteria	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Dose Level 1

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Dose Level 2

Serious events: 2 serious events

Other events: 2 other events

Deaths: 1 deaths

Dose Level 3

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Dose Level 4A

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Dose Level 4B

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Dose Level 4C

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Measure	Dose Level 1 n=3 participants at risk Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 10 million cells of Descartes-11 via intravenous catheter on Days 7,14	Dose Level 2 n=4 participants at risk Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 32 million cells of Descartes-11 via intravenous catheter on Days 7,14	Dose Level 3 n=3 participants at risk Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 100 million cells of Descartes-11 via intravenous catheter on Days 7,14	Dose Level 4A n=2 participants at risk Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,14,21	Dose Level 4B n=4 participants at risk Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,10,14,21	Dose Level 4C n=4 participants at risk Participants were not administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 1,4, 7,10,14,21
Gastrointestinal disorders Ileus	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	25.0% 1/4 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Immune system disorders Febrile Neutropenia	33.3% 1/3 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	25.0% 1/4 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	33.3% 1/3 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Nervous system disorders Encephalopathy	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	25.0% 1/4 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Infections and infestations Sepsis	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	25.0% 1/4 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Infections and infestations Infusion reactions	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	25.0% 1/4 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Blood and lymphatic system disorders Plasmacytoma	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	33.3% 1/3 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Infections and infestations Dental Infection	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	33.3% 1/3 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Musculoskeletal and connective tissue disorders Generalized weakness	66.7% 2/3 • Number of events 2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Musculoskeletal and connective tissue disorders Pathologic fractures of right femur and left humerus	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	25.0% 1/4 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Blood and lymphatic system disorders Hypotension	66.7% 2/3 • Number of events 2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Blood and lymphatic system disorders Hypoxia	33.3% 1/3 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Immune system disorders Fever, etiology unknown	33.3% 1/3 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	50.0% 1/2 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Respiratory, thoracic and mediastinal disorders Upper Resipratory Infection	33.3% 1/3 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Immune system disorders Fever (preapheresis)	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	25.0% 1/4 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.

Other adverse events

Measure	Dose Level 1 n=3 participants at risk Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 10 million cells of Descartes-11 via intravenous catheter on Days 7,14	Dose Level 2 n=4 participants at risk Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 32 million cells of Descartes-11 via intravenous catheter on Days 7,14	Dose Level 3 n=3 participants at risk Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 100 million cells of Descartes-11 via intravenous catheter on Days 7,14	Dose Level 4A n=2 participants at risk Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,14,21	Dose Level 4B n=4 participants at risk Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,10,14,21	Dose Level 4C n=4 participants at risk Participants were not administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 1,4, 7,10,14,21
Gastrointestinal disorders Aspartate aminotransferase increased	66.7% 2/3 • Number of events 2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	25.0% 1/4 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Renal and urinary disorders Chronic Kidney Disease	33.3% 1/3 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
General disorders Fatigue	33.3% 1/3 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	50.0% 2/4 • Number of events 2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Respiratory, thoracic and mediastinal disorders Dyspnea on exertion	33.3% 1/3 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Immune system disorders Granulocyte count decreased	33.3% 1/3 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Metabolism and nutrition disorders Hypoalbuminemia	33.3% 1/3 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	50.0% 2/4 • Number of events 2 • Follow ups conducted on months 3,6,9,12.	33.3% 1/3 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Musculoskeletal and connective tissue disorders Back pain	66.7% 2/3 • Number of events 2 • Follow ups conducted on months 3,6,9,12.	25.0% 1/4 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	33.3% 1/3 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	25.0% 1/4 • Number of events 1 • Follow ups conducted on months 3,6,9,12.
Blood and lymphatic system disorders Anemia	100.0% 3/3 • Number of events 3 • Follow ups conducted on months 3,6,9,12.	50.0% 2/4 • Number of events 2 • Follow ups conducted on months 3,6,9,12.	33.3% 1/3 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	50.0% 1/2 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	50.0% 2/4 • Number of events 2 • Follow ups conducted on months 3,6,9,12.	25.0% 1/4 • Number of events 1 • Follow ups conducted on months 3,6,9,12.
Immune system disorders Neutropenic fever	33.3% 1/3 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	33.3% 1/3 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Nervous system disorders Syncope	33.3% 1/3 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Immune system disorders Fever (Etiology Unknown)	33.3% 1/3 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Blood and lymphatic system disorders Thrombocytopenia	33.3% 1/3 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	25.0% 1/4 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	50.0% 1/2 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	25.0% 1/4 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	33.3% 1/3 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Immune system disorders Infusion Related Reaction	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	50.0% 2/4 • Number of events 2 • Follow ups conducted on months 3,6,9,12.	66.7% 2/3 • Number of events 2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Metabolism and nutrition disorders Hypocalcemia	33.3% 1/3 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	25.0% 1/4 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	25.0% 1/4 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Gastrointestinal disorders Dysphagia	33.3% 1/3 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	50.0% 1/2 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	33.3% 1/3 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/2 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.
Metabolism and nutrition disorders Hyperglycemia	33.3% 1/3 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	0.00% 0/4 • Follow ups conducted on months 3,6,9,12.	0.00% 0/3 • Follow ups conducted on months 3,6,9,12.	50.0% 1/2 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	25.0% 1/4 • Number of events 1 • Follow ups conducted on months 3,6,9,12.	25.0% 1/4 • Number of events 1 • Follow ups conducted on months 3,6,9,12.

Additional Information

Dr. Vera Sarkodie Medical Director,

Cartesian Therapeutics

Phone: 617-231-8085

Email: vera.sarkodie@cartesiantx.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place