CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Large B-cell Lymphoma
- Conditions
- Lymphoma, Non-HodgkinDiffuse Large B Cell Lymphoma
- Registration Number
- NCT06149169
- Lead Sponsor
- Shanghai Ming Ju Biotechnology Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. =18 years old;<br><br> 2. Sign on the informed consent;<br><br> 3. Subjects must have histologically confirmed Large B-cell Lymphoma;<br><br> 4. Subjects had been treated with anthracyclines and rituximab(or other CD20-targeted<br> antibodies) and had relapsed, failed to respond, or progressed after at least two<br> lines of therapy include autologous hematopoietic stem cell<br> transplantation(auto-HSCT);<br><br> 5. Subjects have accessible PET-positive lesion and have measurable CT-positive lesion<br> according to Lugano Classification;<br><br> 6. Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;<br><br> 7. Adequate organ function;<br><br> 8. Adequate vascular access for leukapheresis procedur;<br><br> 9. Subjects who have previously received CD19 targeted therapy must confirm that<br> lymphoma lesions still expresss CD19;<br><br> 10. Women of childbearing potential must agree to use highly effective methods of<br> contraception for 1 year after the last dose of Relma-cel;<br><br> 11. Males who have partners of childbearing potential must agree to use an effective<br> barrier contraceptive method for 1 year after the last dose of Relma-cel.<br><br>Exclusion Criteria:<br><br> 1. Central nervous system(CNS) only involvement by malignancy or primary CNS lymphoma;<br><br> 2. History of another primary malignancyn that has not been in remission for at least 2<br> years;<br><br> 3. Subjects has HBV,HCV,HIV or syphilis nefection at the time of screening;<br><br> 4. Active deep venous thrombosis(DVT)/Pulmonary embolism(PE),or active DVT/PE requires<br> anti-coagulation within 3 months prior to signing the ICF;<br><br> 5. Subjects with uncontrolled systemic fungal,bacterial,viral or other infection;<br><br> 6. Presence of acute or chronic graft-versus-host disease(GVHD);<br><br> 7. History of any serious cardiovascular disease or presence of clinically relevant CNS<br> pathology;<br><br> 8. Pregnant or nursing woman;<br><br> 9. Subjects using of any chemotherapy,corticisteriod,experiment agents,GVHD<br> therapies,radiation,allo-HSCT or any other therapies for lymphoma must go through a<br> specific wash-out period before leukapheresis;<br><br> 10. Uncontrolled conditions or unwillingness or inability to follow the procedures<br> required in the protocol;<br><br> 11. Received CAR T-cell or other genetically-modified T-cell therapy previously.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic(PK)-Cmax of Relma-cel;Pharmacokinetic(PK)-Tmax of Relma-cel;Pharmacokinetic(PK)-AUC of Relma-cel
- Secondary Outcome Measures
Name Time Method Objective response rate (ORR) in LBCL subjects;Best objective response rate ( Best ORR) in LBCL subjects;Complete response rate (CRR) in LBCL subjects;Adverse events (AEs);Duration of response (DOR);Progression-free survival (PFS);Overall survival (OS);Changes of serum cytokines-IL-2,IL-6,IL-8 and IFN- ?;Changes of inflammation biomarker-CRP;Changes of inflammation biomarker-serum ferritin