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New treatment option for Lymphomas
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
ClinicalTrials.gov ID: NCT05773040
What this study is testing
What is JV-213?
JV-213 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lymphomas.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must meet the following in order to be eligible for participation in this trial:
- For the dose escalation cohort: Eligible patients will include those with r/r B-cell lymphoma including LBCL (DLBCL, HGBCL, LBCL transformed from...
- Received at least 2 prior lines of therapy, including anti-CD20 antibody and anthracycline therapy for LBCL, anti-CD20 antibody and alkylating agent...
- Patients who have received prior CD19 CAR cell therapy using FMC63 antibody for targeting CD19 are eligible and must be at least 6 weeks post CAR...
- ≥18 years of age
You likely can't join if
- Patients will be excluded from participating in the trial if he/she has:
- Active central nervous system (CNS) lymphoma including patients with detectable cerebrospinal fluid malignant cells or brain metastases. Patients...
- 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.
See the full eligibility criteria
Who can join
- Patients must meet the following in order to be eligible for participation in this trial:
- For the dose escalation cohort: Eligible patients will include those with r/r B-cell lymphoma including LBCL (DLBCL, HGBCL, LBCL transformed from indolent lymphoma, and PMBCL), FL, marginal zone lymphoma, and MCL after...
- Received at least 2 prior lines of therapy, including anti-CD20 antibody and anthracycline therapy for LBCL, anti-CD20 antibody and alkylating agent or lenalidomide therapy for FL, anti-CD20 antibody and alkylating...
- Patients who have received prior CD19 CAR cell therapy using FMC63 antibody for targeting CD19 are eligible and must be at least 6 weeks post CAR infusion and have \<5% of peripheral blood T cells expressing the prior...
- ≥18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- At least one measurable lesion per the Lugano 2014 Classification53
- At least two weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic anti-cancer therapy prior to leukapheresis. For patients treated with monoclonal antibody-based therapies, at least 4...
- Toxicities due to prior therapy must be stable and recovered to ≤grade 1 (except for clinically non-significant toxicities such as alopecia)
- Absolute neutrophil count of ≥1.0×10\^9/L
- Absolute lymphocyte count of ≥0.1×10\^9/L
- Platelet count of ≥75×10\^9/L
- Creatinine clearance (as estimated by Cockcroft Gault) ≥45 mL/min
- Serum alanine transaminase (ALT) / aspartate transaminase (AST) ≤5 times the upper limit of normal (ULN)
- Total bilirubin ≤2 mg/dL, except in patients with Gilbert's syndrome.
- Cardiac ejection fraction ≥45% with no evidence of clinically significant pericardial effusion
- Baseline oxygen saturation ≥92% on room air
- Women of childbearing potential must have a negative serum or urine pregnancy test (women who have had hysterectomy and women who are over the age of 45 years and
What rules you out
- Patients will be excluded from participating in the trial if he/she has:
- Active central nervous system (CNS) lymphoma including patients with detectable cerebrospinal fluid malignant cells or brain metastases. Patients with prior CNS lymphoma that has been effectively treated will be...
- 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 (e.g. Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) requiring systemic immunosuppression/systemic disease modifying agents within the last 1 year or inflammatory disease...
- History of any form of primary immunodeficiency that in the opinion of the investigator may affect how well it works of the CAR-T product.
- History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association, cardiac angioplasty or stenting, myocardial infarction...
- History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 2 years and treated with curative intent. Patients with a prior history of...
- Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management. Simple urinary tract infection and uncomplicated bacterial pharyngitis or localized...
- Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR...
- History or presence of CNS disorders such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
- Patients with cardiac atrial or cardiac ventricular lymphoma involvement
- Requirement for urgent therapy due to tumor mass effect such as bowel obstruction or blood vessel compression
- Any medical condition likely to interfere with assessment of safety or how well it works of study treatment
- Live vaccine ≤6 weeks prior to planned start of conditioning regimen
- Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the conditioning chemotherapy on the fetus or infant.
- Females of childbearing potential and males of child fathering potential who are not willing to practice two methods of birth control from the time of consent through 6 months after infusion of the study drug
- In the investigator's judgment, the patient is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.