JWCAR239 in Patients With B Cell Non-Hodgkin Lymphoma

NCT07024147 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: JWCAR239001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

JWCAR239 is a CD19/CD20 CAR-T product. This trial is intended to evaluate the safety, PK/PD and efficacy of JWCAR239 in patients with B Cell Non-Hodgkin Lymphoma (B-NHL)

Conditions

B-Cell Non-Hodgkin Lymphoma; Large B Cell Diffuse Lymphoma; Follicular Lymphoma; Marginal Zone B Cell Lymphoma; Mantle Cell Lymphoma (MCL)

Keywords

CAR-T; dual target; B-NHL

Outcome Measures

Primary Outcomes (2)

• The rate of Dose Limiting Toxicity events

  Dose-Limiting Toxicity (DLT) refers to a specific type of adverse effect or toxic reaction caused by a drug or treatment that is severe enough to prevent an increase in dose or continuation of treatment.

  28 days

• AE and SAE rate

  ny adverse event (AE) or serious adverse event (SAE) occurring after JWCAR239 administration

  up to 2 years

Secondary Outcomes (9)

• Pharmacokinetic (PK)- Cmax of JWCAR239

  from baseline up to 2 years

• PD

  from baseline up to 2 years

• overall response rate (ORR)

  from baseline up to 2 years

• complete response rate (CRR)

  from baseline up to 2 years

• duration of response(DOR)

  from baseline up to 2 years

Other Outcomes (1)

• The change of serum cytokines concentration

  from baseline up to 2 years

Study Arms (1)

JWCAR239 arm

EXPERIMENTAL

Participants will receive cyclophosphamide 250-300mg/m\^2/day intravenously (IV) and fludarabine 25-30mg/m\^2/day IV conditioning chemotherapy for 3 days followed by JWCAR239 administered as a single IV infusion at a target dose of 2 .5-30x 10\^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells on Day 1.

Biological: JWCAR239; Drug: Fludarabine; Drug: Cyclophosphamide

Interventions

JWCAR239 BIOLOGICAL

A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells targeting CD19/CD20

JWCAR239 arm

Fludarabine DRUG

Administered according to package insert

JWCAR239 arm

Cyclophosphamide DRUG

Administered according to package insert

JWCAR239 arm

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed B-NHL with immunohistochemical positivity for CD20 and/or CD19 (accepting previous pathological reports and/or pathological review results of previous or fresh tumor tissues). According to the 2022 World Health Organization (WHO) classification, the pathological types include:Diffuse large B-cell lymphoma, Follicular large B-cell lymphoma (FL3B),Large B-cell lymphoma transformed from indolent B-NHL, Follicular lymphoma (excluding in situ follicular lymphoma, pediatric-type follicular lymphoma, and duodenal-type follicular lymphoma),Marginal zone lymphoma Mantle cell lymphoma (excluding in situ mantle cell neoplasms and leukemic non-nodal mantle cell lymphoma)
• Relapsed or refractory disease after receiving two or more lines of adequate treatment, or failure after autologous hematopoietic stem cell transplantation (ASCT).
• CT-measurable lesions and PET-evaluable positive lesions as defined by the 2014 Lugano criteria (lymph node or extranodal lesions must have two measurable diameters; lymph node lesions must have a long diameter \>1.5 cm, and extranodal lesions must have a long diameter \>1 cm).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate organ function:
• Sufficient bone marrow function as assessed by the investigator (absolute neutrophil count ≥1,000/μL after at least 72 hours off growth factors; platelet count ≥50,000/μL without blood transfusion within 7 days; absolute lymphocyte count ≥100/μL).
• Serum creatinine ≤1.5× upper limit of normal (ULN) or creatinine clearance ≥50 mL/min (calculated by the Cockcroft-Gault formula).
• Alanine aminotransferase (ALT) ≤5×ULN and total bilirubin \<2×ULN (or \<3×ULN for subjects with Gilbert syndrome or hepatic involvement by lymphoma).
• Pulmonary function: ≤ CTCAE Grade 1 dyspnea and SpO2 ≥92% in room air. Cardiac function: Left ventricular ejection fraction (LVEF) ≥50% as assessed by echocardiography.
• Adequate vascular access for leukapheresis.
• Expected survival \>12 weeks.
• Non-abstinent female subjects of childbearing potential must agree to use a highly effective contraceptive method plus an additional barrier method from at least 28 days before lymphodepletion until 2 years after JWCAR239 infusion. Male subjects with fertile partners must agree to use effective contraception from at least 28 days before lymphodepletion until 2 years after JWCAR239 infusion and must not donate semen or sperm throughout the study.

You may not qualify if:

• Lymphoma involving the central nervous system (CNS).
• EBV-positive DLBCL or Richter transformation of chronic lymphocytic leukemia.
• History of other malignant tumors with complete remission for less than 2 years, or current presence of other malignant tumors (exceptions to the 2-year restriction include: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, treated localized prostate cancer, biopsy-confirmed cervical in situ carcinoma, or cervical smears showing squamous intraepithelial lesions, or completely resected tumors with low recurrence potential as assessed by the investigator).
• At screening, the subject has:
• Active hepatitis B or C (subjects with HBV DNA or HCV RNA below the lower limit of the central reference value by PCR may be enrolled). For occult or prior HBV-infected subjects, prophylactic antiviral therapy and regular monitoring of HBV-DNA are required.
• Human immunodeficiency virus (HIV) infection or syphilis infection.
• Acute deep vein thrombosis (DVT) (tumor thrombus or thrombus) or pulmonary embolism (PE) within 3 months prior to informed consent signing.
• Receiving anticoagulant therapy for acute DVT or PE within 3 months prior to informed consent signing (prophylactic treatment ).
• Uncontrolled systemic fungal, bacterial, viral, or other infections.
• Acute or chronic graft-versus-host disease (GvHD).
• History of any of the following cardiovascular diseases within the past 6 months: New York Heart Association (NYHA) Class III or IV heart failure, coronary angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant heart diseases.
• Clinically significant CNS disease or symptoms at screening or within the past 6 months, such as epilepsy, seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychiatric disorders.
• Pregnant or lactating women. Females of childbearing potential must have a negative serum pregnancy test within 48 hours before starting lymphodepletion chemotherapy.
• Use of any of the following drugs or treatments within the specified time before leukapheresis:
• Alemtuzumab within 6 months before leukapheresis. Bendamustine within 6 months before leukapheresis. Cladribine within 3 months before leukapheresis. Fludarabine within 3 months before leukapheresis. Anti-CD20 monoclonal antibodies within 7 days before leukapheresis. Venetoclax within 4 days before leukapheresis. Idelalisib within 2 days before leukapheresis. Lenalidomide within 1 day before leukapheresis. Pharmacological doses of corticosteroids (defined as prednisone \>5 mg/day or equivalent) within 7 days before leukapheresis or within 72 hours before JWCAR239 injection. Physiological replacement, topical, and inhaled steroids are permitted.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead
• Shanghai JW Therapeutics Co., Ltd.: collaborator

Study Sites (1)

Beijing cancer hospital

Beijing, Beijing Municipality, 100010, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone; Lymphoma, Mantle-Cell

Interventions

fludarabine; Cyclophosphamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

Yuqin Song, PhD

CONTACT

+86 010-88121122; songyuqin622@163.com

JW medical JWCAR239

CONTACT

+86 21 50464201; JWCAR029Medical@jwtherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 17, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2030
• Last Updated: June 17, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)