This is a Phase 1, first-in-human, open-label, multicenter study of CC-97540, CD19-targeted NEX-T chimeric antigen receptor (CAR) T cells, in subjects with relapsed or refractory B-cell non-Hodgkin lymphoma. The study will consist of 2 parts: dose-escalation (Part A) and dose-expansion (Part B). The dose-escalation part (Part A) of the study is to evaluate the safety and tolerability of increasing dose levels of CC-97540 to establish a recommended Phase 2 dose (RP2D); and the dose-expansion part (Part B) of the study is to further evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of CC-97540 at the RP2D.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to produce CC 97540. During CC 97540 production, subjects may receive bridging chemotherapy for disease control. Upon successful generation of CC 97540 product, subjects will receive treatment with CC 97540 therapy. Each cycle will include lymphodepleting chemotherapy followed by one dose of CC 97540 administered by intravenous (IV) injection.
Local Institution - 003
Birmingham, Alabama, United States
Local Institution - 004
Atlanta, Georgia, United States
Local Institution - 011
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Nebraska Medicine Fred and Pamela Buffett Cancer Center
Omaha, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Local Institution - 001
New York, New York, United States
Local Institution - 008
New York, New York, United States
Local Institution - 010
Charlotte, North Carolina, United States
Oregon Health and Science University OHSU
Portland, Oregon, United States
...and 4 more locations
Adverse Events (AEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.ject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the sub
Time frame: From the time of informed consent and follow up to 2 years after infusion of CC-97540
Complete Response Rate (CRR)
The proportion of subjects with a best overall response of complete response (CR).
Time frame: Up to 2 years after CC-97540 infusion
Overall response Rate (ORR)
The proportion of subjects achieving CR or partial response (PR).
Time frame: Up to 2 years after CC-97540 infusion
Duration of response (DOR)
The time from first response to progressive disease (PD) or death.
Time frame: Up to 2 years after CC-97540 infusion
Time to response (TTR)
Time from CC-97540 infusion to the first documentation of response (CR or PR).
Time frame: Up to 2 years after CC-97540 infusion
Time to complete response (TTCR)
Time from CC-97540 infusion to the first documentation of CR
Time frame: Up to 2 years after CC-97540 infusion
Progression free survival (PFS)
Time from CC-97540 infusion to the first documentation of PD, or death from any cause, whichever occurs first
Time frame: Up to 2 years after CC-97540 infusion
Overall survival (OS)
Time from CC-97540 infusion to death
Time frame: Up to 2 years after CC-97540 infusion
Pharmacokinetics - peak expansion (Cmax)
Maximum blood concentration
Time frame: Up to 2 years after CC-97540 infusion
Pharmacokinetics -time to peak expansion (tmax)
Time to peak (maximum) blood concentration
Time frame: Up to 2 years after CC-97540 infusion
Pharmacokinetics - elimination half-life (t1/2)
Elimination half-life
Time frame: Up to 2 years after CC-97540 infusion
Pharmacokinetics - Area under curve (AUC)
Area under the curve
Time frame: Up to 2 years after CC-97540 infusion
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