Actively Recruiting
A Phase 1 Study of JV-213 Autologous CD79b-targeting Chimeric Antigen Receptor T-cell Therapy in Adults With Relapsed or Refractory B-cell Lymphomas
Led by M.D. Anderson Cancer Center · Updated on 2026-05-18
33
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying JV-213, a new type of autologous CAR T cell therapy targeting CD79b, in adults with relapsed or refractory B-cell lymphomas. This phase 1 trial aims to find the highest dose of JV-213 that can be safely given to patients who have not responded to previous treatments. The study also explores how well the treatment works and how it affects the body, including how the immune cells behave and potential biomarkers linked to response and side effects. Participants will receive JV-213 through an intravenous (IV) infusion after their own T cells are collected via leukapheresis. The trial has two parts: a dose escalation phase where small groups receive increasing doses to find the maximum tolerated dose, and a dose expansion phase where more participants receive the recommended dose identified in the first part. Each group includes 3 to 6 patients, and dosing is adjusted based on safety observations. During the study, participants will be monitored closely for side effects using standard criteria and evaluated for tumor response and symptom relief. Researchers will collect blood and tumor samples to study the treatment’s effects and track patient health over about one year. Safety, tumor response rates, duration of response, progression-free survival, and overall survival will be measured throughout the trial.
CONDITIONS
Brief Title
A Phase 1 Study of JV-213 Autologous CD79b-targeting Chimeric Antigen Receptor T-cell Therapy in Adults With Relapsed or Refractory B-cell Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with relapsed or refractory B-cell lymphoma types including LBCL, FL, marginal zone lymphoma, MCL, or Burkitt lymphoma as specified
- Have received at least 2 prior systemic therapies appropriate for lymphoma type
- Prior CD19 CAR therapy allowed if at least 6 weeks post-infusion and low CAR T cells in blood
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- At least one measurable lymphoma lesion
- At least two weeks or 5 half-lives since prior systemic anti-cancer therapy before leukapheresis
- Stable toxicities from prior therapy at grade 1 or less (except non-significant toxicities)
- Adequate blood counts: neutrophils 31.0 x 10^9/L, lymphocytes 5.0 x 10^8/L, platelets 375 x 10^9/L
- Creatinine clearance 45 mL/min
- Liver function: ALT/AST 4-5 times upper limit normal, total bilirubin 42 mg/dL (exceptions for Gilbert's syndrome)
- Cardiac ejection fraction 45% without significant pericardial effusion
- Baseline oxygen saturation 52% on room air
- Negative pregnancy test for women of childbearing potential
- Willingness for birth control as required
You will not qualify if you...
- Active central nervous system lymphoma or brain metastases
- Use of CAR therapies with antibodies other than FMC63
- History of Richter's transformation of chronic lymphocytic leukemia
- Recent autologous or allogeneic stem cell transplantation within specified timeframes
- Active graft versus host disease
- Active autoimmune or inflammatory diseases needing systemic immunosuppression within last year
- History of primary immunodeficiency affecting CAR-T therapy efficacy
- Recent significant cardiovascular events or severe heart failure
- History of other malignancies unless disease-free for at least 2 years
- Uncontrolled infections requiring IV antimicrobials
- Known infections with HIV, hepatitis B or C unless viral load undetectable
- CNS disorders like seizures, dementia, or autoimmune CNS diseases
- Cardiac lymphoma involvement
- Urgent need for therapy due to tumor mass effect
- Any medical condition interfering with safety or efficacy assessment
- Live vaccine within 6 weeks before conditioning
- Pregnancy or breastfeeding
- Unwillingness to use effective birth control
- Unlikely to complete study visits or comply with protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo leukapheresis to collect cells for the CAR T-cell therapy preparation.
1 visit (in-person)
Duration - Up to several weeks depending on dose escalation and treatment schedule
Participants receive JV-213 CAR T-cell therapy by intravenous infusion at varying dose levels to determine the maximum tolerated dose or recommended phase 2 dose.
1 infusion visit followed by multiple monitoring visits during treatment
Duration - Up to 1 year
Participants are monitored for safety, tumor response, and symptom relief after treatment with JV-213.
Regular visits for safety and efficacy assessments
Trial Site Locations
Total: 1 location
1
The University of Texas M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Sattva Neelapu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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