Trial Title:
Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
NCT ID:
NCT06500273
Condition:
Large B-cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Cyclophosphamide
Fludarabine
Conditions: Keywords:
Diffuse large B-cell lymphoma
DLBCL
Primary mediastinal B-cell lymphoma
LBCL
High grade B-cell lymphoma
HGBCL
Double-hit lymphoma
High-risk lymphoma
Minimal Residual Disease
MRD
CAR T
Allogeneic CAR T
CD19
cema-cel
cemacabtagene ansegedleucel
ALLO-647
PMBCL
Consolidation
First-line
Front-line
Frontline
PhasED-Seq™
CLARITY™
Anti-CD52
AlloCAR T™
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Genetic
Intervention name:
cemacabtagene ansegedleucel
Description:
An allogeneic CAR T cell therapy targeting CD19
Arm group label:
cemacabtagene ansegedleucel
Arm group label:
cemacabtagene ansegedleucel, ALLO-647
Other name:
cema-cel
Intervention type:
Biological
Intervention name:
ALLO-647
Description:
A monoclonal antibody targeting CD52
Arm group label:
cemacabtagene ansegedleucel, ALLO-647
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
Chemotherapy for lymphodepletion
Arm group label:
cemacabtagene ansegedleucel
Arm group label:
cemacabtagene ansegedleucel, ALLO-647
Other name:
Fludara®
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Chemotherapy for lymphodepletion
Arm group label:
cemacabtagene ansegedleucel
Arm group label:
cemacabtagene ansegedleucel, ALLO-647
Other name:
Cytoxan®
Intervention type:
Device
Intervention name:
Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™
Description:
A diagnostic test intended to identify patients with minimal residual disease at the end
of first line treatment for lLBCL.
Arm group label:
Observation
Arm group label:
cemacabtagene ansegedleucel
Arm group label:
cemacabtagene ansegedleucel, ALLO-647
Other name:
Foresight Lymphoma MRD Therapy Selection Test
Summary:
This is a randomized, open-label study in adult patients who have completed standard
first line of therapy for large B-cell lymphoma (LBCL) and achieved a complete response
or partial response suitable for observation, but who have minimal residual disease (MRD)
as detected by the Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered by
PhasED-Seq™. The purpose of the trial is to assess the efficacy and safety of
consolidation with cemacabtagene ansegedleucel (cema-cel), an allogeneic CD19 CAR T
product, as compared to standard of care observation.
The study is conducted in 2 consecutive parts that will be enrolled continuously. In Part
A of the study, participants with MRD are randomized to one of two treatment arms or an
observation arm. Treatment includes cema-cel following a lymphodepletion regimen of
fludarabine and cyclophosphamide administered with or without the anti-CD52 monoclonal
antibody, ALLO-647. Part A will culminate with the selection of the lymphodepletion
regimen to advance to Part B. Part B will evaluate the selected lymphodepletion regimen
followed by cema-cel as compared with observation.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
1. LBCL per WHO 2017 including diffuse large B-cell lymphoma, high-grade B-cell
lymphoma, and primary mediastinal B-cell lymphoma histologically confirmed by
pathology report.
2. Participant has completed a full course of standard first line therapy (e.g.,
R-CHOP, dose-adjusted EPOCH-R, Pola-R-CHP) as intended. Participants cannot have
received additional lines of therapy.
3. Participant achieved CR, or PR suitable for observation at the end of first line
therapy based on PET/CT evaluation
4. Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™, is positive.
5. Adult participants ≥18 years of age.
6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
7. Adequate hematological, renal, hepatic, pulmonary, and cardiac function
8. Non-hematologic toxicities related to prior therapy must be recovered to baseline or
grade ≤1.
Key Exclusion Criteria:
1. LBCL with history of central nervous system involvement, transformed from other
malignancy (e.g., transformed follicular lymphoma or marginal zone lymphoma,
Richter's transformation), or T-cell/histiocyte rich LBCL.
2. Prior treatment with anti-CD19 targeted therapies.
3. Anti-cancer treatment, including radiation, after end of treatment PET/CT and/or MRD
testing is performed.
4. Active and clinically significant autoimmune disease.
5. Active systemic bacterial, fungal, or viral infections requiring systemic treatment
(e.g., HIV).
6. History of another primary malignancy or bone marrow disorder (e.g., myelofibrosis,
smoldering multiple myeloma) within 3 years prior to enrollment.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Alta Bates Summit Medical Center
Address:
City:
Berkeley
Zip:
94704
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Rajest Behl, MD
Email:
Principal Investigator
Facility:
Name:
Cedars-Sinai Medical Center
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Akil Merchant, MD
Email:
Principal Investigator
Facility:
Name:
Rocky Mountain Cancer Centers
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Investigator:
Last name:
John Burke, MD
Email:
Principal Investigator
Facility:
Name:
Medical Oncology Hematology Consultants
Address:
City:
Newark
Zip:
19713
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Jamal Misleh, MD
Email:
Principal Investigator
Facility:
Name:
Advent Health Cancer Institute
Address:
City:
Orlando
Zip:
32804
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Rushang Patel, MD
Email:
Principal Investigator
Facility:
Name:
Indiana Blood and Marrow Transplantation
Address:
City:
Indianapolis
Zip:
46237
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Anand Tandra, MD
Email:
Principal Investigator
Facility:
Name:
University of Kentucky Medical Center
Address:
City:
Lexington
Zip:
40536
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Chaitanya Iragavarapu, MD
Email:
Principal Investigator
Facility:
Name:
Norton Cancer Institute
Address:
City:
Louisville
Zip:
40207
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Don Stevens, MD
Email:
Principal Investigator
Facility:
Name:
Washington University School of Medicine - Siteman Cancer Center
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Nancy Bartlett, MD
Email:
Principal Investigator
Facility:
Name:
Astera Cancer Care
Address:
City:
East Brunswick
Zip:
08816
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Edward Licitra, MD
Email:
Principal Investigator
Facility:
Name:
Rutgers Cancer Institute of New Jersey
Address:
City:
New Brunswick
Zip:
08901
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Matthew Matasar, MD
Email:
Principal Investigator
Facility:
Name:
Columbia University Irving Medical Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Ran Reshef, MD
Email:
Principal Investigator
Facility:
Name:
Oncology Hematology Care - Kenwood
Address:
City:
Cincinnati
Zip:
45236
Country:
United States
Status:
Recruiting
Investigator:
Last name:
James Essell, MD
Email:
Principal Investigator
Facility:
Name:
Oncology Associates of Oregon
Address:
City:
Eugene
Zip:
97401
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Jeff Sharman, MD
Email:
Principal Investigator
Facility:
Name:
Texas Oncology - Central South
Address:
City:
Austin
Zip:
78705
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Jason Melear, MD
Email:
Principal Investigator
Facility:
Name:
Texas Oncology - Dallas Fort Worth
Address:
City:
Dallas
Zip:
75246
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Houston Holmes, MD
Email:
Principal Investigator
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Jason Westin, MD
Email:
Principal Investigator
Facility:
Name:
Texas Transplant Institute
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Nosha Farhadfar, MD
Email:
Principal Investigator
Facility:
Name:
Texas Oncology - Tyler
Address:
City:
Tyler
Zip:
75702
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Habte Yimer, MD
Email:
Principal Investigator
Facility:
Name:
University of Virginia
Address:
City:
Charlottesville
Zip:
22903
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Indumathy Varadarajan, MD
Email:
Principal Investigator
Facility:
Name:
Virginia Cancer Specialists
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Mitul Gandhi, MD
Email:
Principal Investigator
Facility:
Name:
Virginia Oncology Associates - Norfolk
Address:
City:
Norfolk
Zip:
23502
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Gary Simmons, MD
Email:
Principal Investigator
Start date:
June 18, 2024
Completion date:
August 24, 2031
Lead sponsor:
Agency:
Allogene Therapeutics
Agency class:
Industry
Collaborator:
Agency:
Foresight Diagnostics, Inc.
Agency class:
Other
Source:
Allogene Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06500273
