Cemacabtagene Ansegedleucel (Cema-Cel for Large B-Cell Lymphoma)

Purpose of this Study

We are doing this study to find out if an experimental drug called cema-cel is a safe and effective option for patients with large B-cell lymphoma. Cema-cel is a CAR T Cell therapy that is made from your own white blood cells. We also want to compare how well cema-cel works when it is given with and without another experimental drug called ALLO-647.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Are diagnosed with large B-cell lymphoma; AND
  • Have achieved a clinical response or partial response from previous treatment that makes them suitable for observation
For more information about who can join this study, please contact the study team at quinna.marshburn@duke.edu.

Age Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to join this study, you will go through a screening period that lasts around 28 days to see if you are eligible to take part. If you are eligible, you will proceed to the study period. During the study period, you will get a random assignment (like a coin flip) to 1 of 2 groups:
  • One group will take a regimen that uses cema-cell
  • The other group will not receive any treatment and will continue to have their health and condition monitored by their doctor(s)
If you are assigned to get the study drug, you will get another random assignment:
  • You will either get a drug regimen that involves lymphodepletion with fludarabine, cyclophosphamide, and ALLO-647 followed by getting a dose of cema-cel; OR
  • You will get a drug regimen that involves lymphodepletion with only fludarabine and cyclophosphamide followed by getting a dose of cema-cel

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

Study Details

Full Title

A randomized, open-label study evaluating the efficacy and safety of cemacabtagene
ansegedleucel in participants with minimal residual disease after response to first
line therapy for large B-cell lymphoma (ALPHA3)

Principal Investigator

Mitchell
Horwitz

Protocol Number

PRO00115840

NCT ID

NCT06500273

Phase

II

Enrollment Status

Open to Enrollment
ClinicalTrials.gov