The purpose of this study is to evaluate the efficacy and safety of NXC-201 compared with Dara-CyBorD (daratumumab-cyclophosphamide-bortezomib-dexamethasone) in the treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.
Eastern Cooperative Oncology Group performance status score ≤2
Newly diagnosed AL Amyloidosis per consensus criteria as defined in the protocol
Measurable disease as defined in the protocol
One or more organs impacted by AL amyloidosis
Prior therapy for AL amyloidosis or multiple myeloma
Diagnosis of multiple myeloma
Cardiac stage IIIb patients
History of malignancy (other than AL amyloidosis) within 3 years
Parallel
NXC-201
Biological/VaccineNXC-201 CAR-T is defined as autologous T cells transduced ex-vivo with anti-BCMA CAR retroviral vector encoding a proprietary chimeric antigen receptor (CAR) targeted to human BCMA.
Dara-CyBorD
DrugDaratumumab plus CyBorD combination
Overall complete hematologic response (CHR) rate using consensus recommendations for AL amyloidosis treatment response criteria per protocol
CHR rate is defined as percentage of participants who achieved CHR
Major Organ Deterioration Progression-Free Survival (MOD-PFS)
MOD-PFS is defined as duration from the date of randomization to either hematologic progression, or major organ deterioration (clinical manifestation of cardiac failure or renal failure), or death, whichever occurs first
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Nexcella Inc.
Lead sponsor
Immix Biopharma, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
