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Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma

Phase I Safety Study of Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03994705
Enrollment
20
Registered
2019-06-21
Start date
2019-08-01
Completion date
2021-06-11
Last updated
2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

CAR-T, CART, CAR T Cell, CAR T-Cell, Multiple Myeloma, BCMA, B cell maturation antigen, B-cell maturation antigen, Descartes-11

Brief summary

This Phase I study will test the safety and anti-myeloma activity of ascending doses of Descartes-11 (autologous CD8+ T-cells expressing an anti-BCMA chimeric antigen receptor) in eligible patients with active multiple myeloma.

Interventions

BIOLOGICALDescartes-11

CAR T-Cells

DRUGFludarabine

Pre-conditioning chemotherapy

DRUGCyclophosphamide

Pre-conditioning therapy

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Cartesian Therapeutics
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Active multiple myeloma that is refractory after at least 2 prior lines of therapy; * measurable disease; * adequate vital organ function; and * no active infection.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Treatment-Related Adverse EventsTime Frame: 21 daysDetermine the safety of Descartes-11 in patients with relapsed/refractory multiple myeloma

Secondary

MeasureTime frameDescription
Disease Assessment Based on International Myeloma Working Group (IMWG) CriteriaDisease 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).

Countries

United States

Participant flow

Participants by arm

ArmCount
Level 1 Dose
10 x 10\^6 cells / kg
3
Level 2 Dose
32 x 10\^6 cells / kg
4
Level 3 Dose
100 x 10\^6 cells / kg
3
Level 4A
150 x 10\^6 cells / kg
2
Level 4B
150 x 10\^6 cells / kg
4
Level 4C
150 x 10\^6 cells / kg
4
Total20

Baseline characteristics

CharacteristicLevel 4CLevel 1 DoseLevel 2 DoseLevel 3 DoseLevel 4ALevel 4BTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
3 Participants1 Participants1 Participants1 Participants2 Participants4 Participants12 Participants
Age, Categorical
Between 18 and 65 years
1 Participants2 Participants3 Participants2 Participants0 Participants0 Participants8 Participants
Race/Ethnicity, Customized
Asian
0 participants0 participants1 participants0 participants0 participants0 participants1 participants
Race/Ethnicity, Customized
Other-Non Hispanic
1 participants0 participants0 participants0 participants0 participants0 participants1 participants
Race/Ethnicity, Customized
White
2 participants3 participants3 participants3 participants2 participants4 participants16 participants
Race/Ethnicity, Customized
White (Hispanic)
2 participants0 participants0 participants0 participants0 participants0 participants2 participants
Region of Enrollment
United States
4 participants3 participants4 participants3 participants2 participants4 participants20 participants
Sex: Female, Male
Female
0 Participants1 Participants2 Participants1 Participants1 Participants2 Participants7 Participants
Sex: Female, Male
Male
4 Participants2 Participants2 Participants2 Participants1 Participants2 Participants13 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
0 / 31 / 40 / 30 / 20 / 41 / 4
other
Total, other adverse events
3 / 32 / 42 / 31 / 23 / 42 / 4
serious
Total, serious adverse events
3 / 32 / 41 / 31 / 21 / 40 / 4

Outcome results

Primary

Number of Participants With Treatment-Related Adverse Events

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

Time frame: Time Frame: 21 days

Population: Participants with treatment related adverse event

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Dose-Escalation Level 1Number of Participants With Treatment-Related Adverse Events0 Participants
Dose Level 2Number of Participants With Treatment-Related Adverse Events1 Participants
Dose Level 3Number of Participants With Treatment-Related Adverse Events1 Participants
Dose Level 4ANumber of Participants With Treatment-Related Adverse Events0 Participants
Dose Level 4BNumber of Participants With Treatment-Related Adverse Events0 Participants
Dose Level 4CNumber of Participants With Treatment-Related Adverse Events0 Participants
Secondary

Disease Assessment Based on International Myeloma Working Group (IMWG) Criteria

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

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Dose-Escalation Level 1Disease Assessment Based on International Myeloma Working Group (IMWG) Criteria0 Participants
Dose Level 2Disease Assessment Based on International Myeloma Working Group (IMWG) Criteria0 Participants
Dose Level 3Disease Assessment Based on International Myeloma Working Group (IMWG) Criteria0 Participants
Dose Level 4ADisease Assessment Based on International Myeloma Working Group (IMWG) Criteria0 Participants
Dose Level 4BDisease Assessment Based on International Myeloma Working Group (IMWG) Criteria0 Participants
Dose Level 4CDisease Assessment Based on International Myeloma Working Group (IMWG) Criteria0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026