Health TrialsbyHealthPanel

JWCAR201 for the Treatment of Hematology Malignancy and Autoimmune Diseases

ConditionsB-cell TumorsAutoimmune DiseasesLupus Erythematosus, SystemicLarge B-cell Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorRenJi Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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.

Severe lupus nephritis requiring hemodialysis within 2 months before screening, or treatment with prednisone ≥ 100 mg/day or equivalent corticosteroids for ≥ 14 days.

Trial design

Design model

Single group

Treatments tested in this trial

  • JWCAR201

    Biological/Vaccine

    JWCAR201 is a autologous CAR-T targeting CD19/CD20

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: JWCAR201 armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
28 days
2

the rate of AE and SAE

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

Time frame
up to 2 years

Secondary outcomes

1

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

to evaluate PK properties of JWCAR201, that is, how the human body processes the infused JWCAR201 cells

Time frame
from baseline up to 2 years
2

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

these are parameters to evaluate PD properties of JWCAR201

Time frame
from baseline up to 2 years
3

overall response rate (ORR) in subjects with hematology malignancy

ORR is the proportion of subjects who achieve positive response to the treatment. It includes complete response and partial response.

Time frame
from baseline up to 2 years
4

complete response rate (CRR) in subjects with hematology malignancy

CRR refers to the proportion of subjects whose cancer signs disappear

Time frame
from baseline up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RenJi Hospital

Lead sponsor

Shanghai Ming Ju Biotechnology Co., Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: