CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Mantle Cell Lymphoma

Overview

This is a phase II, open-label, single-arm, multicenter study to assess the efficacy and safety of JWCAR029 in adult R/R Mantle Cell Lymphoma subjects in China.

Full Title of Study: “A Phase II Open-Label, Single-Arm, Multicenter Study of JWCAR029, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells for Relapsed and Refractory (R/R) Mantle Cell Lymphoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 25, 2023

Detailed Description

This is a phase II, open-label, single-arm, multicenter study conducted in adult subjects with relapsed and refractory (R/R) mantle cell lymphoma (MCL) in China to evaluate the safety, efficacy, pharmacokinetics(PK), pharmacodynamics(PD) of JWCAR029 and immune response after JWCAR029 treatment. R/R MCL patients will be enrolled in dose level of 1.0 x 10^8 CAR+ T cells. All subjects will be followed for 5 years following JWCAR029 infusion.

Interventions

  • Biological: CD19-targeted Chimeric Antigen Receptor (CAR) T Cells
    • JWCAR029 will be administered at dose level: 1 x 10^8 CAR+T cells

Arms, Groups and Cohorts

  • Experimental: JWCAR029 treatment
    • JWCAR029 be administrated at dose level: 1 x 10^8 CAR+T cells

Clinical Trial Outcome Measures

Primary Measures

  • Objective response rate (ORR)
    • Time Frame: 3 months
    • Objective response rate (ORR) in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects

Secondary Measures

  • Complete response rate (CRR)
    • Time Frame: 3 months
    • Complete response rate (CRR) in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects
  • The best objective response rate
    • Time Frame: 3 months
    • The best objective response rate in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects
  • The best complete response rate
    • Time Frame: 3 months
    • The best complete response rate in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects
  • Number of participants with adverse events (AEs)
    • Time Frame: Up to 24 months after JWCAR029 infusion
    • Number of participants with adverse events
  • Type of adverse events (AEs)
    • Time Frame: Up to 24 months after JWCAR029 infusion
    • Type of adverse events
  • Severity of adverse events(AEs)
    • Time Frame: Up to 24 months after JWCAR029 infusion
    • Severity of adverse events
  • Number of participants with laboratory abnormalities
    • Time Frame: Up to 24 months after JWCAR029 infusion
    • Number of participants with laboratory abnormalities
  • Type of laboratory abnormalities
    • Time Frame: Up to 24 months after JWCAR029 infusion
    • Type of laboratory abnormalities
  • Severity of laboratory abnormalities
    • Time Frame: Up to 24 months after JWCAR029 infusion
    • Severity of laboratory abnormalities
  • Duration of response (DOR)
    • Time Frame: Up to 24 months after JWCAR029 infusion
    • Time from first response(PR or CR) to disease progression or death from any cause
  • Duration of complete remission (DoCR)
    • Time Frame: Up to 24 months after JWCAR029 infusion
    • Time from complete response (CR) to disease progression or death from any cause
  • Duration of partial remission (DoPR)
    • Time Frame: Up to 24 months after JWCAR029 infusion
    • Time from partial response (PR) to disease progression or death from any cause.
  • Time to response (TTR)
    • Time Frame: Up to 24 months after JWCAR029 infusion
    • Time from JWCAR029 infusion to first documentation of complete response (CR) or partial response (PR)
  • Time to complete response (TTCR)
    • Time Frame: Up to 24 months after JWCAR029 infusion
    • Time from JWCAR029 infusion to first documentation of complete response (CR)
  • Cmax of JWCAR029
    • Time Frame: Up to 1 year after JWCAR029 infusion
    • Maximum observed concentration of JWCAR029 in peripheral blood
  • Tmax of JWCAR029:
    • Time Frame: Up to 1 year after JWCAR029 infusion
    • Time to maximum concentration of JWCAR029 in the peripheral blood
  • AUC of JWCAR029:
    • Time Frame: Up to 1 year after JWCAR029 infusion
    • Area under the concentration vs time curve of JWCAR029 in the peripheral blood
  • Progression-free survival (PFS)
    • Time Frame: Up to 2 year after JWCAR029 infusion
    • Progression-free survival
  • Overall survival (OS)
    • Time Frame: Up to 5 year after JWCAR029 infusion
    • Overall survival
  • Anti-therapeutic JWCAR029 antibody
    • Time Frame: Up to 2 year after JWCAR029 infusion
    • Anti-therapeutic JWCAR029 antibody
  • Changes of T cell counts
    • Time Frame: Up to 2 year after JWCAR029 infusion
    • Changes of T cell counts
  • Changes of Subgroups of T cell
    • Time Frame: Up to 2 year after JWCAR029 infusion
    • Changes of Subgroups of T cell
  • Changes of serum cytokines
    • Time Frame: Up to 2 year after JWCAR029 infusion
    • Changes of serum cytokines
  • CD19 expression in tumor biopsy samples
    • Time Frame: Up to 2 year after JWCAR029 infusion
    • CD19 expression in tumor biopsy samples
  • Changes in inflammatory biomarkers such as CRP
    • Time Frame: Up to 2 year after JWCAR029 infusion
    • Changes in inflammatory biomarkers such as CRP
  • Changes in inflammatory biomarkers such as ferritin
    • Time Frame: Up to 2 year after JWCAR029 infusion
    • Changes in inflammatory biomarkers such as CRP

Participating in This Clinical Trial

Inclusion Criteria

  • ≥ 18 years old; – Sign on the informed consent; – Subject must have histologically confirmed mantle cell lymphoma; – Relapsed/refractory patients; – Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification; – Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; – Expected survival is greater than 12 weeks; – Adequate organ function; – Adequate vascular access for leukapheresis procedure; – Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19; – Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of JWCAR029; – 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:

  • Central nervous system (CNS) only involvement by malignancy or primary CNS lymphoma; – History of another primary malignancy that has not been in remission for at least 2 years; – Subjects has HBV, HCV, HIV or syphilis infection at the time of screening; – Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or DVT/PE requires anti-coagulation within 3 months prior to signing the ICF; – Subjects with uncontrolled systemic fungal, bacterial, viral or other infection; – Presence of acute or chronic graft-versus-host disease (GVHD); – History of any serious cardiovascular disease or presence of clinically relevant CNS pathology; – Pregnant or nursing women; – Subjects using of any chemotherapy, corticosteriod, experiment agents, GVHD therapies, radiation or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis; – Received allo-hematopoietic stem cell transplantation therapy previously. – Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol; – Received CAR T-cell or other genetically-modified T-cell therapy previously.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai Ming Ju Biotechnology Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor

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