An Open-label, Single-arm Study of JWCAR201 in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma

NCT06517004 | Recruiting Phase 1 DMC

• 1 other identifier: JWCAR201002
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single-arm study to investigate the efficacy and safety signals of JWCAR201 amongst subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Conditions

Diffuse Large B Cell Lymphoma

Keywords

CAR-T therapy; Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• Rate of dose-limiting toxicities (DLTs)

  Dose limiting toxicities for each subject

  28 days

• AE/SAE

  Incidence and severity of adverse events (AE), and serious adverse event (SAE)

  24 months

Secondary Outcomes (7)

• Copy number of the vector transgene of JWCAR201 in peripheral blood

  24 months

• CD19-positive cells and CD20-positive cells in peripheral blood

  24 months

• Objective response rate (ORR)

  24 months

• Complete response rate (CRR)

  24 months

• Duration of response (DOR)

  24 months

Study Arms (1)

JWCAR201 Treatment Arm

EXPERIMENTAL

Patients will be administrated with autologous CD19/CD20-directed CAR-T cells after lymphocyte depletion by fludarabine and cyclophosphamide.

Biological: JWCAR201

Interventions

JWCAR201 BIOLOGICAL

Autologous CD19/CD20-directed CAR-T cells, single infusion intravenously

JWCAR201 Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18
• Voluntarily willing to participate in the study and sign the written informed consent form
• Histologically confirmed diffuse large B-cell lymphoma (DLBCL) with immunohistochemistry (IHC) CD20-positive
• Patients must be priorly treated by Anthracyclines and anti-CD20-targeted regimens, and must be refractory or relapsed to at least ≥2 treatment lines of standard of care or autologous hematopoietic stem-cell transplantation (HSCT)
• At least one measurable lesion by CT or PET per Lugano criteria
• Eastern Cooperative Oncology Group (ECOG) performance status scale ≤1
• Adequate organ functions
• Adequate venous access for apheresis
• Women of childbearing potential must agree to use an effective and reliable contraceptive method till 1-year post-infusion
• Male patients who have not undergone vasectomy and have sexual activity with women of childbearing potential must agree to the use of a barrier contraceptive till 1-year post-infusion

You may not qualify if:

• Primary central nervous system lymphoma
• Another primary malignancy within 2 years
• Active infections of hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or syphilis
• With severe active deep venous thrombosis or pulmonary embolism within 3 months
• Treated with anti-coagulations (except for prophylaxis use) due to severe active deep venous thrombosis or pulmonary embolism within 3 months
• Uncontrolled or active infection
• Acute or chronic graft-versus-host disease (GvHD)
• With severe cardiovascular diseases within 6 months
• With severe clinically-significant central nervous system disorders within 6 months
• Pregnant or lactating women
• Not satisfying pre-defined wash-out period for apheresis
• Unable or unwilling to comply with the study protocol, judged by the investigator, or other situations implying that the subject might not be appropriate to participate in the study
• Previously treated with any genetically engineered modified T-cell therapy nor other cell-gene therapy

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Rong Tao, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rong Tao, MD

CONTACT

+8621-64175590; rtao@shca.org.cn

Wenhao Zhang, MD

CONTACT

+8621-64175590

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: July 18, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)