Clinical trial NCT03994705: Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma
Official title: Phase I Safety Study of Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
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
Lead sponsor: Cartesian Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-06-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events
timeFrame: Time Frame: 21 days
Secondary outcomes:
measure: Disease Assessment Based on International Myeloma Working Group (IMWG) Criteria
timeFrame: Disease assessment is on Day 21 (or at least 14 days after first Descartes-11 infusion)
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Madison
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
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