JWCAR201 for the Treatment of Hematology Malignancy and Autoimmune Diseases

NCT06567080 | Not Yet Recruiting Phase 1

• 1 other identifier: JWCAR201001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

JWCAR201 is a CD19/CD20 CAR-T product. This trial is intended to evaluate the safety, PK/PD and efficacy of JWCAR201 in patients with B cell driven hematology malignancy and autoimmune diseases

Conditions

B-cell Tumors; Autoimmune Diseases; Lupus Erythematosus, Systemic; Large B-cell Lymphoma

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

• the rate of AE and SAE

  any adverse event (AE) or serious adverse event (SAE) occurring after JWCAR201 administration

  up to 2 years

Secondary Outcomes (18)

• the change of number of JWCAR201 cells by measuring the cell number and the number of transgene copies over time

  from baseline up to 2 years

• the change of numbers of B cell subtypes (e.g., CD19+, CD20+ B cells) in the blood

  from baseline up to 2 years

• overall response rate (ORR) in subjects with hematology malignancy

  from baseline up to 2 years

• complete response rate (CRR) in subjects with hematology malignancy

  from baseline up to 2 years

• duration of response in subjects with hematology malignancy

  from baseline up to 2 years

Study Arms (1)

JWCAR201 arm

EXPERIMENTAL

Subjects in this arm will receive intervention with JWCAR201

Biological: JWCAR201

Interventions

JWCAR201 BIOLOGICAL

JWCAR201 is a autologous CAR-T targeting CD19/CD20

JWCAR201 arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For subjects with B cell driven malignancy (relapsed/refractory large B cell lymphoma)
• aged \>= 18 years
• willing to sign ICF
• with histologically confirmed large B cell lymphoma and immunohistochemically positive CD20
• The subject must have previously been treated with an anthracycline and rituximab (or another CD20-targeted therapy), and must have relapsed, not achieved remission, or experienced disease progression after receiving at least two lines of therapy, including autologous hematopoietic stem cell transplantation (autoHSCT)
• The subject must have CT measurable lesions and PET evaluable lesions as determined by the Lugano criteria.
• The subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• For subjects with SLE:
• Voluntarily sign the informed consent form (ICF).
• At the time of signing the ICF, be between 18 and 70 years old (inclusive of 18 and 70 years), with no restriction on gender.
• Have been diagnosed with SLE (Systemic Lupus Erythematosus) for ≥ 6 months before screening, according to the 2019 EULAR/ACR revised criteria
• Have previously required treatment with corticosteroids combined with immunosuppressants and biologics, with the treatment regimen stable for \>2 months and the dose stable for \>2 weeks before screening, yet the disease remains active.
• At the time of screening, positive for antinuclear antibodies (ANA), and/or anti-dsDNA antibodies, and/or anti-Smith antibodies.
• SLEDAI-2K score ≥ 7 points during the screening period.

You may not qualify if:

• For subjects with B cell driven malignancy (relapsed/refractory large B cell lymphoma)
• \. Primary central nervous system (CNS) lymphoma (subjects with secondary CNS lymphoma are allowed to enroll).
• \. A history of another malignancy that has not been in complete remission for at least 2 years (the following conditions are exempt from the 2-year restriction: non-melanoma skin cancer, completely resected stage I tumors with a low likelihood of recurrence, treated localized prostate cancer, biopsy-confirmed in situ cervical cancer, or squamous intraepithelial lesions identified on a PAP smear).
• \. At the time of screening, the subject has:
• Hepatitis B surface antigen (HBsAg) positivity (regardless of whether or not there is an increase in hepatitis B virus DNA copies).
• Hepatitis B core antibody (HBcAb) positivity with an increase in hepatitis B virus DNA copies.
• Hepatitis C, HIV, or syphilis infection. 4. The subject has had active deep vein thrombosis (DVT) (tumor thrombus or blood clot) or pulmonary embolism (PE) within 3 months prior to signing the informed consent form.
• \. The subject has been undergoing anticoagulant therapy for active DVT or PE within 3 months prior to signing the informed consent form (prophylactic treatment is excluded).
• \. Uncontrolled systemic fungal, bacterial, viral, or other infections. 7. Acute or chronic graft-versus-host disease (GvHD). 8. History of any of the following cardiovascular diseases within the past 6 months: New York Heart Association (NYHA) Class III or IV heart failure, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant heart diseases.
• \. Clinically significant CNS diseases within the past 6 months or at the time of screening, such as epilepsy, seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychiatric disorders.
• \. Pregnant or breastfeeding women. Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to the start of lymphodepleting chemotherapy.
• \. The investigator determines that the subject has any factors that could affect compliance with the protocol, including uncontrolled medical, psychological, familial, sociological, or geographical conditions; or the subject is unwilling or unable to comply with the procedures required by the study protocol.
• \. The subject has previously received CAR-T cell therapy or other gene-modified T cell therapy.
• For subjects with SLE:
• Severe lupus nephritis requiring hemodialysis within 2 months before screening, or treatment with prednisone ≥ 100 mg/day or equivalent corticosteroids for ≥ 14 days.

Sponsors & Collaborators

• RenJi Hospital: lead
• Shanghai Ming Ju Biotechnology Co., Ltd.: collaborator

Study Sites (1)

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200001, China

Location

MeSH Terms

Conditions

Autoimmune Diseases; Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Immune System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Liangjing Lu

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liangjing Lu

CONTACT

86-13661472001; Lu_liangjing@163.com

medical JW JW

CONTACT

+86 21 50464201; Relma-celMedical@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: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 22, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)