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Trial Title:
Relmacabtagene Autoleucel as First-Line Therapy for High-Risk Large B-Cell Lymphoma
NCT ID:
NCT05590221
Condition:
B-cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Cyclophosphamide
Fludarabine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Relmacabtagene Autoleucel
Description:
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
Arm group label:
Relmacabtagene Autoleucel
Other name:
JWCAR029
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
Administered according to package insert
Arm group label:
Relmacabtagene Autoleucel
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Administered according to package insert
Arm group label:
Relmacabtagene Autoleucel
Summary:
The primary objective of this study is to estimate the efficacy of Relmacabtagene
Autoleucel in participants with high-risk large B-cell lymphoma.
Detailed description:
This is a prospective, open-label, multicenter, single-arm trial, assessed the efficacy
and safety of JWCAR029(relma-cel) as part of first-line therapy after an incomplete
first-line treatment regimen of two cycles of chemoimmunotherapy. High-risk LBCL was
defined by the dynamic risk assessment of interim PET2+, together with either double- or
triple-hit lymphomas or high-intermediate- and high-risk IPI scores (≥3). All sujects
will be followed for 2 years following JWCAR029 infusion.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. ≥ 18 years old;
2. Sign on the informed consent;
3. Histologically confirmed large B-cell lymphoma that also meets the definition of
high-risk large B-cell lymphoma as a lymphoma International Prognostic Index (IPI)
score of 3-5 and/or high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6
rearrangement (double/triple-hit lymphoma) (DHL/THL) and must be treated with 2
cycles of CD20 monoclonal antibodies combined with anthracyclines. Presence of
positive PET assessable lesions (DS score of 4 or 5) as determined by the Lugano
criteria (Cheson et al., 2014)；
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
5. Expected survival greater than 12 weeks；
6. Adequate organ function：
1. Absolute neutrophil count ≥ 1000/μL；Absolute lymphocyte count ≥ 100/μL；
Platelet count ≥ 75,000/μL；Hb ≥ 80g/L；
2. Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance
(Cockcroft-Gault formula) > 50 mL/min (serum creatinine clearance due to
lymphoma mass compression should be > 30 mL/min)；
3. Serum alanine aminotransferase (ALT) ≤ 5 upper limit of normal (ULN) and total
bilirubin ≤2ULN（or for subjects with Gilbert's syndrome or lymphoma invading
the liver < 3 ULN）；
4. Baseline oxygen saturation > 92% on room air；
5. Left ventricular ejection fraction (LVEF) ≥50% assessed by echocardiography or
radionuclide activity angiography (MUGA) within 1 month of enrollment；
7. Adequate vascular access for leukapheresis procedure;
8. Women of childbearing potential must agree to use highly effective methods of
contraception for at least 28 days prior to lymphocyte clearance chemotherapy
through 1 year after Relmacabtagene Autoleucel infusion; Males who have partners of
childbearing potential must agree to use an effective barrier contraceptive method
for 1 year after Relmacabtagene Autoleucel infusion.
Exclusion Criteria:
1. Lymphoma involving the central nervous system (CNS)；
2. History of another primary malignancy that has not been in remission for at least 2
years;
3. History of Richter's transformation of chronic lymphocytic leukemia or primary
mediastinal B-cell lymphoma；
4. Subjects has HBV, HCV, HIV or syphilis infection at the time of screening;
5. Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or DVT/PE requires
anti-coagulation within 3 months prior to signing the ICF;
6. Subjects with uncontrolled systemic fungal, bacterial, viral or other infection;
7. Presence of acute or chronic graft-versus-host disease (GVHD);
8. History of any serious cardiovascular disease or presence of clinically relevant CNS
pathology;
9. Pregnant or nursing women;
10. Subjects Received an autologous or allogeneic hematopoietic stem cell transplant；
11. Uncontrolled conditions or unwillingness or inability to follow the procedures
required in the protocol;
12. Received CAR T-cell or other genetically-modified T-cell therapy previously；
13. Received live vaccination within 6 weeks prior to lymphocyte clearance chemotherapy；
14. History of severe hypersensitivity reactions to any of the drug ingredients used in
this study product.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100010
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuqin Song, PhD
Facility:
Name:
Peking University International Hospital
Address:
City:
Beijing
Zip:
100010
Country:
China
Status:
Recruiting
Contact:
Last name:
Liu xinjian
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Keshu Zhou
Email:
drzhouks77@163.com
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Huilai Zhang
Email:
zhanghltch@163.com
Start date:
January 3, 2023
Completion date:
December 10, 2024
Lead sponsor:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
Shanghai Ming Ju Biotechnology Co., Ltd.
Agency class:
Industry
Source:
Peking University Cancer Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05590221
