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Light Chain (AL) Amyloidosis

5
Pipeline Programs
5
Companies
6
Clinical Trials
2 recruiting
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
0
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Cell Therapy
267%
Monoclonal Antibody
133%
+ 4 programs with unclassified modality

Competitive Landscape

5 companies ranked by most advanced pipeline stage

UNION therapeutics
UNION therapeuticsDenmark - Hellerup
2 programs
2
Daratumumab 16 mg/kgPhase 21 trial
VenetoclaxPhase 21 trial
Active Trials
NCT06629818Recruiting36Est. Oct 2026
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
Immix Biopharma
Immix BiopharmaLOS ANGELES, CA
1 program
1
NXC-201 CAR-TPhase 1/2Cell Therapy1 trial
Active Trials
NCT06097832Recruiting40Est. Jan 2039
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
ProthenaBirtamimab
UNION therapeuticsDaratumumab 16 mg/kg
UNION therapeuticsVenetoclax
Immix BiopharmaNXC-201 CAR-T
Sorrento TherapeuticsSTI-6129
Sorrento TherapeuticsSTI-6129

Clinical Trials (6)

Total enrollment: 380 patients across 6 trials

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: Oct 202636 patients
Phase 2Recruiting
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 203940 patients
Phase 1/2Recruiting
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

2 actively recruiting trials targeting 380 patients
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.