Study to Evaluate the Efficacy and Safety of Relmacabtagene Autoleucel (Relma-cel) as First-Line Therapy in Adult Participants With High-Risk Large B-Cell Lymphoma

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The primary objective of this study is to estimate the efficacy of Relmacabtagene Autoleucel in participants with high-risk large B-cell lymphoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥ 18 years old;

• Sign on the informed consent;

• 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);

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

• Expected survival greater than 12 weeks;

• Adequate organ function:

‣ Absolute neutrophil count ≥ 1000/μL;Absolute lymphocyte count ≥ 100/μL; Platelet count ≥ 75,000/μL;Hb ≥ 80g/L;

⁃ 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);

⁃ 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);

⁃ Baseline oxygen saturation \> 92% on room air;

⁃ Left ventricular ejection fraction (LVEF) ≥50% assessed by echocardiography or radionuclide activity angiography (MUGA) within 1 month of enrollment;

• Adequate vascular access for leukapheresis procedure;

• 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.

Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
Peking University International Hospital
RECRUITING
Beijing
Tianjin Medical University Cancer Institute and Hospital
NOT_YET_RECRUITING
Tianjin
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Yuqin Song, PhD
songyuqin622@163.com
+86 010-88121122
Backup
Medical JWCAR029
JWCAR029Medical@jwtherapeutics.com
+86 21 50464201
Time Frame
Start Date: 2023-01-03
Estimated Completion Date: 2024-12-10
Participants
Target number of participants: 20
Treatments
Experimental: Relmacabtagene Autoleucel
Participants will receive cyclophosphamide250 mg/m\^2/day intravenously (IV) and fludarabine 25 mg/m\^2/day IV conditioning chemotherapy for 3 days followed by Relmacabtagene Autoleucel administered as a single IV infusion at a target dose of 1 x 10\^8 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells on Day 1.
Related Therapeutic Areas
Sponsors
Leads: Peking University Cancer Hospital & Institute
Collaborators: Shanghai Ming Ju Biotechnology Co., Ltd.

This content was sourced from clinicaltrials.gov

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