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Light Chain (AL) Amyloidosis

6
Pipeline Programs
5
Companies
7
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
2
2
0
1
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Cell Therapy
267%
Monoclonal Antibody
133%
+ 5 programs with unclassified modality

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Immix Biopharma
Immix BiopharmaLOS ANGELES, CA
2 programs
1
1
NXC-201Phase 31 trial
NXC-201 CAR-TPhase 1/2Cell Therapy1 trial
Active Trials
NCT06097832Active Not Recruiting45Est. Jan 2039
NCT07709715Not Yet Recruiting260Est. Dec 2032
UNION therapeutics
UNION therapeuticsDenmark - Hellerup
2 programs
2
Daratumumab 16 mg/kgPhase 21 trial
VenetoclaxPhase 21 trial
Active Trials
NCT06629818Active Not Recruiting36Est. Mar 2027
NCT05996406Active Not Recruiting36Est. Sep 2025
Sorrento Therapeutics
Sorrento TherapeuticsCA - San Diego
2 programs
1
1
STI-6129Phase 1/21 trial
STI-6129Phase 11 trial
Active Trials
NCT05692908Withdrawn0Est. Nov 2024
NCT04316442Unknown60Est. Dec 2024
Nexcella
NexcellaCA - Los Angeles
1 program
NXC-201 CAR-TPHASE_1_2Cell Therapy
Prothena
ProthenaDUBLIN 2, Ireland
1 program
BirtamimabPHASE_3Monoclonal Antibody1 trial
Active Trials
NCT04973137Terminated208Est. Jun 2025

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
Immix BiopharmaNXC-201
ProthenaBirtamimab
UNION therapeuticsDaratumumab 16 mg/kg
UNION therapeuticsVenetoclax
Immix BiopharmaNXC-201 CAR-T
Sorrento TherapeuticsSTI-6129
Sorrento TherapeuticsSTI-6129

Clinical Trials (7)

Total enrollment: 645 patients across 7 trials

NCT07709715Immix BiopharmaNXC-201

A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of NXC-201 Compared With Daratumumab With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) in Newly Diagnosed Systemic AL Amyloidosis

Start: Jan 2027Est. completion: Dec 2032260 patients
Phase 3Not Yet Recruiting
NCT04973137ProthenaBirtamimab

A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis

Start: Aug 2021Est. completion: Jun 2025208 patients
Phase 3Terminated
NCT06629818UNION therapeuticsDaratumumab 16 mg/kg

Daratumumab Combined With Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis With Translocation (11;14)

Start: Oct 2024Est. completion: Mar 202736 patients
Phase 2Active Not Recruiting
NCT05996406UNION therapeuticsVenetoclax

Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis with Translocation (11;14)

Start: Sep 2023Est. completion: Sep 202536 patients
Phase 2Active Not Recruiting
NCT06097832Immix BiopharmaNXC-201 CAR-T

Study of NXC-201 CAR-T in Patients With Light Chain (AL) Amyloidosis

Start: Jun 2024Est. completion: Jan 203945 patients
Phase 1/2Active Not Recruiting
NCT04316442Sorrento TherapeuticsSTI-6129

Study of the Safety and Efficacy of STI-6129 in Patients With Relapsed or Refractory Systemic AL Amyloidosis

Start: Apr 2021Est. completion: Dec 202460 patients
Phase 1/2Unknown
NCT05692908Sorrento TherapeuticsSTI-6129

An Open-Label Study of the Safety of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With AL Amyloidosis

Start: Sep 2023Est. completion: Nov 20240
Phase 1Withdrawn

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

1 late-stage (Phase 3) programs, potential near-term approvals
5 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.