Diffuse Large B Cell Lymphoma Clinical Trial
Official title:
CD19-targeted CAR T Cells (JWCAR029) for Primary Refractory Diffuse Large B Cell Lymphoma, Phase Ⅰ,Open-label,Single-arm,Muticenter Study
Verified date | November 2023 |
Source | Shanghai Ming Ju Biotechnology Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a phase I, open-label, single-arm, multicenter study to assess the safety and efficacy of JWCAR029 in adult primary refractory DLBCL subjects in China
Status | Completed |
Enrollment | 12 |
Est. completion date | April 25, 2023 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. = 18 years old; 2. Sign on the informed consent; 3. Subject must have histologically confirmed diffuse large B lymphoma and primary refractory with first-line therapy; 4. Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification; 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 6. Adequate organ function; 7. Adequate vascular access for leukapheresis procedure; 8. Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19; 9. Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of JWCAR029; 10. Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of JWCAR029 Exclusion Criteria: 1. Subjects who have received second-line treatment or above 2. CD19 negative 3. Primary CNS lymphoma; 4. History of another primary malignancy that has not been in remission for at least 2 years; 5. Subjects has HBV, HCV, HIV or syphilis infection at the time of screening; 6. Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or DVT/PE requires anti-coagulation within 3 months prior to signing the ICF; 7. Subjects with uncontrolled systemic fungal, bacterial, viral or other infection; 8. Presence of acute or chronic graft-versus-host disease (GVHD); 9. History of any serious cardiovascular disease or presence of clinically relevant CNS pathology; 10. Pregnant or nursing women; 11. Subjects using of any chemotherapy, corticisteriod, experiment agents, GVHD therapies, radiation, allo-HSCT or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis; 12. Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol; 13. Received CAR T-cell or other genetically-modified T-cell therapy previously. |
Country | Name | City | State |
---|---|---|---|
China | Zhejiang university school of medicine first affiliated hospital | Hangzhou | Zhejiang |
China | Ruijin hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Ming Ju Biotechnology Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Types, frequency, and severity of adverse events and laboratory anomalies | Physiological parameter | 2 years | |
Secondary | Complete response rate (CRR) in primary refractory DLBCL subjects | Investigator evaluated CRR in 1 month | 1 month | |
Secondary | Objective response rate (ORR) in primary refractory DLBCL subjects | Investigator evaluated ORR in 1 month | 1 month | |
Secondary | Best objective response rate (BORR) | The best response from the onset of treatment to the onset of disease progression/recurrence or to the onset of another anticancer treatment | 2 years | |
Secondary | Investigator evaluated CRR | Complete response rate (CRR) | 3 months | |
Secondary | Investigator evaluated ORR (ORR=CR+PR) | Complete response (CR) + partial response(PR) | 3 months | |
Secondary | Duration of response (DOR) | Time from first response(PR or CR) to disease progression or death from any cause | up to 24 months after JWCAR029 infusion | |
Secondary | Duration of complete remission (DoCR) | Time from complete response (CR) to disease progression or death from any cause | up to 24 months after JWCAR029 infusion | |
Secondary | Time to response (TTR) | Time from JWCAR029 infusion to first documentation of CR or PR | up to 24 months after JWCAR029 infusion | |
Secondary | Time to complete response (TTCR) | Time from JWCAR029 infusion to first documentation of CR | up to 24 months after JWCAR029 infusion | |
Secondary | Pharmacokinetic (PK)- Cmax of JWCAR029 | Maximum observed concentration of JWCAR029 in peripheral blood | up to 1 year after JWCAR029 infusion | |
Secondary | Pharmacokinetic (PK)- Tmax of JWCAR029 | Time to maximum concentration of JWCAR029 in the peripheral blood | up to 1 year after JWCAR029 infusion | |
Secondary | Pharmacokinetic (PK)- AUC of JWCAR029 | Area under the concentration vs time curve of JWCAR029 | up to 1 year after JWCAR029 infusion | |
Secondary | Progression-free survival (PFS) | Progression-free survival | up to 2 year after JWCAR029 infusion | |
Secondary | Overall survival (OS) | Overall survival | up to 2 year after JWCAR029 infusion | |
Secondary | Changes of CRP and serum ferritin | Changes of inflammation biomarkers-CRP and serum ferritin | 1 year after JWCAR029 infusion | |
Secondary | Anti-therapeutic JWCAR029 antibody | The level of anti-therapeutic JWCAR029 antibody after JWCAR029 infusion | up to 2 year after JWCAR029 infusion | |
Secondary | The concentration of Car-T cell | The concentration of Car-T cells | up to 2 year after JWCAR029 infusion | |
Secondary | The proportion of Car-T cell subgroups | The proportion of Car-T cell subgroups after infusion | up to 2 year after JWCAR029 infusion | |
Secondary | The concentration of CD19 in tumor biopsy samples | The concentration of CD19 in tumor biopsy samples | up to 2 year after JWCAR029 infusion | |
Secondary | The change of serum cytokines concentration | The change of serum cytokines concentration after JWCAR029 infusion | up to 2 year after JWCAR029 infusion |
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