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Monoclonal Antibodies

CAEL-101 for AL Amyloidosis

Phase 2

Waitlist Available

Research Sponsored by Caelum Biosciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through the study completion, an average of 4 years

Awards & highlights

Study Summary

This trial is for a new drug to treat AL amyloidosis, which is a disease where abnormal proteins create free light chains that bind together and form amyloid fibrils. The new drug, CAEL-101, is being tested to see if it is safe and effective when used in combination with standard care for this disease.

Eligible Conditions

AL Amyloidosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through the study completion, an average of 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through the study completion, an average of 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through the study completion, an average of 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose Limiting Toxicity

Safety Parameters

Secondary outcome measures

PK Parameters (bi-weekly versus monthly CAEL-101 dosing))

Safety parameters to be assessed separately for Parts A (CAEL 101 when administered in combination with standard-of-care CyBorD) and B (CAEL 101 when administered in combination with standard-of-care CyBorD and daratumumab)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part B: CAEL-101 combined with SoC CyBorD and daratumumabExperimental Treatment3 Interventions

CAEL-101 is administered as an intravenous (IV) infusion at the RP3D dose level. CAEL-101 will be administered weekly for the first 4 weeks, and then every other week until end of study, in combination with the SoC CyBorD chemotherapy and daratumumab. After completing approximately 50 weeks of treatment, participants may switch to an alternative maintenance dosing regimen of every four weeks (q4wk), if agreed upon by the Investigator and the Sponsor Medical Monitor. Patients will be treated until death, unacceptable toxicity, symptomatic deterioration, Investigator decision, patient decision or Sponsor decision to terminate the study.

Group II: Part A: CAEL-101 combined with SoC CyBorDExperimental Treatment2 Interventions

CAEL-101 is administered as an intravenous (IV) infusion over approximately 2 hours. The initial cohort dose assignments of CAEL-101 will be: Cohort 1 - 500 mg/m^2 Cohort 2 - 750 mg/m^2 Cohort 3 - 1000 mg/m^2. CAEL-101 will be administered weekly for the first 4 weeks, and then every other week until end of study, in combination with the SoC CyBorD chemotherapy. Patients will be treated until death, unacceptable toxicity, symptomatic deterioration, Investigator decision, patient decision or Sponsor decision to terminate the study. Patients from Part A who are in the Continued Treatment Period and who, in the Investigator's judgment, should have their SoC treatment complemented with daratumumab may do so (Part B).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bortezomib

FDA approved

CAEL-101

2020

Completed Phase 2

~30

Daratumumab

2014

Completed Phase 3

~1860

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Caelum BiosciencesLead Sponsor

2 Previous Clinical Trials

391 Total Patients Enrolled

2 Trials studying AL Amyloidosis

391 Patients Enrolled for AL Amyloidosis

Alexion PharmaceuticalsLead Sponsor

230 Previous Clinical Trials

37,383 Total Patients Enrolled

2 Trials studying AL Amyloidosis

391 Patients Enrolled for AL Amyloidosis

AlexionLead Sponsor

246 Previous Clinical Trials

39,237 Total Patients Enrolled

2 Trials studying AL Amyloidosis

391 Patients Enrolled for AL Amyloidosis

Media Library

CAEL-101 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04304144 — Phase 2

AL Amyloidosis Research Study Groups: Part B: CAEL-101 combined with SoC CyBorD and daratumumab, Part A: CAEL-101 combined with SoC CyBorD

AL Amyloidosis Clinical Trial 2023: CAEL-101 Highlights & Side Effects. Trial Name: NCT04304144 — Phase 2

CAEL-101 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04304144 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has there been any other research conducted concerning CAEL-101?

"Currently, there are 1355 studies that have been launched for CAEL-101 with 273 of these in the third phase. Of those trials, 43689 different locations across the globe are actively recruiting patients. Philadelphia, Pennsylvania is one such site where many CAEL-101 studies are taking place."

Answered by AI

Has CAEL-101 obtained the necessary sanction from the FDA?

"Judging from the available evidence, our team has concluded that CAEL-101 is moderately safe and awarded it a score of 2. This Phase 2 trial lacks proof of efficacy but presents some data confirming safety."

Answered by AI

How is CAEL-101 commonly applied to treat various ailments?

"CAEL-101 is most commonly utilized as a synovitis treatment, but it also has applications for treating ophthalmia, sympathetic disorders, and malignancies of the lung or retina."

Answered by AI

Are there any opportunities to join this investigation at present?

"As per the information on clinicaltrials.gov, this medical trial is not presently enrolling patients. The study was initially posted in March 18th 2020 and has since been updated last January 14th 2022. Though it is no longer recruiting, 1,451 other trials are currently open to participants."

Answered by AI

What is the scope of people involved in this medical investigation?

"As of now, this clinical trial is not actively enrolling participants. The research project was originally listed on March 18th 2020 and has since been updated on January 14th 2022. For those searching for other trials to join, there are currently 96 studies seeking patients suffering from amyloidosis as well as 1355 studies that still require volunteers for CAEL-101 treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis

2020. "A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04304144.