Actively Recruiting
Phase 1 Study of JV-213 CAR T-cell Therapy for Adults with Relapsed or Refractory B-cell Lymphomas Evaluating Safety, Tolerability, and Dose Levels
Led by M.D. Anderson Cancer Center · Updated on 2026-07-29
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. The main goal is to find the highest dose of JV-213 that patients can tolerate safely. This Phase 1 trial also aims to evaluate the therapys safety, tolerability, and the best dose to use in future studies. Participants receive JV-213 through an intravenous infusion after their own immune cells are collected via leukapheresis. The study has two parts the first tests increasing doses of JV-213 in small groups to find the maximum tolerated dose, while the second part treats more patients at this recommended dose. Each participants treatment depends on the dose level assigned during the trial. Throughout the study, participants are closely monitored for side effects using standard criteria for adverse events. Researchers also assess tumor response and symptom relief to measure effectiveness. Blood and tumor samples are collected to study how the therapy works in the body and to identify biomarkers linked to treatment response or side effects. The study continues until December 2028, with approximately one year of follow-up after treatment to assess safety and outcomes.
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 including LBCL, FL, marginal zone lymphoma, MCL, or Burkitt lymphoma
- Have received at least two prior systemic therapies including anti-CD20 antibody and other specified treatments
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have at least one measurable lesion according to Lugano 2014 criteria
- At least two weeks or 5 half-lives since prior systemic anti-cancer therapy before leukapheresis
- Stable toxicities from prior therapy, recovered to grade 1 or less (except non-significant toxicities like alopecia)
- Adequate blood counts: neutrophils ≥ 1.0 x10^9/L, lymphocytes ≥ 0.1 x10^9/L, platelets ≥ 75 x10^9/L
- Creatinine clearance ≥ 45 mL/min
- Liver enzymes (ALT/AST) ≤ 5 times upper limit of normal
- Total bilirubin ≤ 2 mg/dL (except patients with Gilbert's syndrome)
- Cardiac ejection fraction ≥ 45% with no significant pericardial effusion
- Baseline oxygen saturation ≥ 92% on room air
- Women of childbearing potential must have a negative pregnancy test
You will not qualify if you...
- Active central nervous system lymphoma or brain metastases
- History of any CAR cell therapy using non-FMC63 antibody
- History of Richter's transformation of chronic lymphocytic leukemia
- Autologous stem cell transplantation within 6 weeks
- Allogeneic stem cell transplantation within 3 months or active graft versus host disease
- Active autoimmune disease requiring systemic immunosuppressive therapy within the last year
- History of primary immunodeficiency affecting CAR-T efficacy
- Recent significant cardiovascular events within 6 months
- History of malignancy other than certain skin or in situ cancers unless disease-free for 2 years
- Uncontrolled infections requiring intravenous treatment
- Known HIV or active hepatitis B or C infection
- CNS disorders such as seizure, stroke, dementia, or autoimmune CNS disease
- Cardiac lymphoma involvement
- Need for urgent therapy due to tumor mass effect
- Any medical condition interfering with safety or efficacy assessment
- Live vaccine within 6 weeks before starting conditioning regimen
- Pregnant or breastfeeding women
- Participants unwilling to use two forms of birth control during and 6 months after treatment
- Unlikely to complete all study visits or comply with study requirements
Research Team
S
Sattva Neelapu, MD
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