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 2025-11-10
33
Participants Needed
1
Research Sites
246 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To find the highest tolerable dose of JV-213 (a type of autologous CAR T cell therapy) that can be given to patients who have B-cell lymphoma that is relapsed or refractory.
CONDITIONS
Official 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
- Diagnosis of relapsed or refractory B-cell lymphoma including LBCL (DLBCL, HGBCL, LBCL transformed from indolent lymphoma, PMBCL), FL, marginal zone lymphoma, MCL, or Burkitt lymphoma (with specific prior therapy requirements)
- At least 2 prior systemic therapies for LBCL, FL, marginal zone lymphoma, or MCL; at least 1 prior therapy for Burkitt lymphoma
- Prior CD19 CAR T-cell therapy allowed if at least 6 weeks have passed and peripheral blood T cells expressing prior CAR are below 5%
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- At least one measurable lesion per the Lugano 2014 Classification
- At least 2 weeks or 5 half-lives since last systemic anti-cancer therapy before leukapheresis (4 weeks for monoclonal antibody therapies)
- Stable toxicities from prior therapy, recovered to grade 1 or less (except alopecia)
- Absolute neutrophil count ≥1.0 x 10^9/L
- Absolute lymphocyte count ≥0.1 x 10^9/L
- Platelet count ≥75 x 10^9/L
- Creatinine clearance ≥45 mL/min
- Serum ALT/AST ≤5 times upper limit of normal
- Total bilirubin ≤2 mg/dL (except Gilbert's syndrome)
- Cardiac ejection fraction ≥45% with no significant pericardial effusion
- Baseline oxygen saturation ≥92% on room air
- Negative pregnancy test for women of childbearing potential or surgical sterilization or age over 45
You will not qualify if you...
- Active central nervous system lymphoma or detectable malignant cells in cerebrospinal fluid or brain metastases
- Prior CAR T-cell therapy using non-FMC63 antibody
- History of Richter's transformation of chronic lymphocytic leukemia
- Autologous stem cell transplant within 6 weeks
- Allogeneic stem cell transplant within 3 months or active graft versus host disease
- Active autoimmune disease requiring systemic immunosuppression within last year
- History of primary immunodeficiency affecting CAR T efficacy
- Significant cardiovascular conditions within past 6 months including class III/IV heart failure or myocardial infarction
- History of other malignancies unless disease-free for at least 2 years
- Active infections requiring intravenous antimicrobials (except some localized infections)
- Known HIV, hepatitis B (HBsAg positive), or hepatitis C infection unless viral load undetectable
- CNS disorders such as seizures, stroke, dementia, or CNS autoimmune disease
- Cardiac lymphoma involvement
- Urgent need for therapy due to tumor mass effect like bowel obstruction
- Any medical condition interfering with safety or efficacy assessment
- Live vaccine within 6 weeks prior to conditioning regimen
- Pregnancy or breastfeeding in women of childbearing potential
- Unwillingness to use two methods of birth control during study and 6 months after
- Unlikely to complete study visits or comply with study requirements as judged by investigator
AI-Screening
AI-Powered Screening
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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
CONTACT
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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