LymphomasPhase 1NCT05773040
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
A Phase 1 study testing JV-213 and Leukapheresis in people with Lymphomas and B-cell Lymphomas, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphomas, B-cell Lymphomas
- What is being tested?
- JV-213 and Leukapheresis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2023to 31 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet the following inclusion criteria 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 at least 2 prior systemic therapies and Burkitt lymphoma after at least 1 prior systemic therapy. For the dose expansion cohort: Patients with r/r LBCL (DLBCL, HGBCL, LBCL transformed from indolent lymphoma, and PMBCL) and FL grade 3B will be eligible
- 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 agent or lenalidomide or BTK inhibitor therapy for marginal zone lymphoma, and anti-CD20 antibody and alkylating agent or BTK inhibitor therapy for MCL. Patients with Burkitt lymphoma may be eligible after 1 line of prior therapy including anti-CD20 antibody and anthracycline therapy.
- 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 CAR by flow cytometry assessment.
- ≥18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
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- 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 weeks must have elapsed prior to leukapheresis.
- 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
Who cannot join
- 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 eligible if treatment was completed at least one year prior to enrolment and there is no evidence of disease on MRI with gadolinium contrast at the time of screening.
- 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.
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- 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 (including graft versus host disease) requiring systemic immunosuppressive therapy. Physiological replacement of corticosteroids of up to 7.5 mg of prednisone or equivalent per day, and topical and inhaled corticosteroids are permitted.
- History of any form of primary immunodeficiency that in the opinion of the investigator may affect efficacy 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, unstable angina, or other clinically significant cardiac disease.
- 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 malignancy whose natural history or treatment (e.g. hormonal therapy) does not have the potential to interfere with either the safety or efficacy assessment of the investigational regimen in the opinion of the investigator may be included.
- 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 skin infections are permitted if responding to active treatment and after consultation with the Principal Investigator.
- 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 and/or nucleic acid testing.
- 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 efficacy 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas M D Anderson Cancer Center
Houston, Texas, 77030
Sattva Neelapu, MD, 713-563-3429, sneelapu@mdanderson.org
Sattva Neelapu, MD
About this study
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.
Read the detailed description
Primary Objectives:
--The primary objective is to determine the safety and identify the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of JV-213 in patients with r/r B-cell lymphomas.
Hypothesis: JV-213 will be safe, well-tolerated, and effective in patients with r/r B-cell lymphomas.
Secondary Objectives:
--The secondary objective is to determine the efficacy in adults with r/r LBCL and FL grade 3B treated at the MTD or RP2D of JV-213. Although the clinical benefit of JV-213 has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability. Secondary endpoints include overall response rate (ORR; including CR + PR) and CR rate as defined by the Lugano Classification response criteria for malignant lymphoma,53 DOR, PFS, and OS.
Hypothesis: JV-213 will induce an ORR of at least 40% in adult subjects with r/r B-cell lymphomas.
Exploratory Objectives:
--The exploratory objectives are to assess the cellular kinetics and pharmacodynamic effects of JV-213 anti-CD79b CAR T-cell product and to evaluate biomarkers associated with response, resistance, and toxicity after administration of JV-213 in blood and tumor samples.
- Conditions
- Lymphomas, B-cell Lymphomas
- Being tested
- JV-213, Leukapheresis
- Keywords
- B-cell lymphoma, CD79b, CAR T cell therapy
- Medical subject headings
- Lymphoma, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JV-213Drug
Given by (IV) vein
LeukapheresisProcedure or surgery
Given by IV (vein)
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (dose escalation) | Experimental | Part 1, the dose of JV-213 participants receive will depend on when you join this study. Up to 3 dose levels of JV-213 will be tested. About 3-6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level of JV-213. Each new group will receive a higher dose of JV-213 than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of JV-213 is found. Receives: Drug: JV-213; Procedure: Leukapheresis |
| Part 2 (dose expansion) | Experimental | Participants will receive JV-213 at the recommended dose that was found in Part 1. Receives: Drug: JV-213; Procedure: Leukapheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5
Measured: through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start14 Apr 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomasStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sattva Neelapu, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773040
- Sponsor's protocol ID
- 2022-0938
- Other IDs
- NCI-2023-02055
- Status last verified
- Jul 2026
- First submitted
- 1 Mar 2023
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- 2022-0938
- Conditions
- Lymphomas, B-cell Lymphomas
- Keywords
- B-cell lymphoma, CD79b, CAR T cell therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objectives:
--The primary objective is to determine the safety and identify the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of JV-213 in patients with r/r B-cell lymphomas.
Hypothesis: JV-213 will be safe, well-tolerated, and effective in patients with r/r B-cell lymphomas.
Secondary Objectives:
--The secondary objective is to determine the efficacy in adults with r/r LBCL and FL grade 3B treated at the MTD or RP2D of JV-213. Although the clinical benefit of JV-213 has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability. Secondary endpoints include overall response rate (ORR; including CR + PR) and CR rate as defined by the Lugano Classification response criteria for malignant lymphoma,53 DOR, PFS, and OS.
Hypothesis: JV-213 will induce an ORR of at least 40% in adult subjects with r/r B-cell lymphomas.
Exploratory Objectives:
--The exploratory objectives are to assess the cellular kinetics and pharmacodynamic effects of JV-213 anti-CD79b CAR T-cell product and to evaluate biomarkers associated with response, resistance, and toxicity after administration of JV-213 in blood and tumor samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 (dose escalation) | Experimental | Drug: JV-213, Procedure: LeukapheresisPart 1, the dose of JV-213 participants receive will depend on when you join this study. Up to 3 dose levels of JV-213 will be tested. About 3-6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level of JV-213. Each new group will receive a higher dose of JV-213 than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of JV-213 is found. |
| Part 2 (dose expansion) | Experimental | Drug: JV-213, Procedure: LeukapheresisParticipants will receive JV-213 at the recommended dose that was found in Part 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients must meet the following inclusion criteria 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 at least 2 prior systemic therapies and Burkitt lymphoma after at least 1 prior systemic therapy. For the dose expansion cohort: Patients with r/r LBCL (DLBCL, HGBCL, LBCL transformed from indolent lymphoma, and PMBCL) and FL grade 3B will be eligible
- 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 agent or lenalidomide or BTK inhibitor therapy for marginal zone lymphoma, and anti-CD20 antibody and alkylating agent or BTK inhibitor therapy for MCL. Patients with Burkitt lymphoma may be eligible after 1 line of prior therapy including anti-CD20 antibody and anthracycline therapy.
- 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 CAR by flow cytometry assessment.
- ≥18 years of age
Key exclusion criteria (20 listed)
- 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 eligible if treatment was completed at least one year prior to enrolment and there is no evidence of disease on MRI with gadolinium contrast at the time of screening.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JV-213Given by (IV) vein | Drug | Part 1 (dose escalation), Part 2 (dose expansion) |
| LeukapheresisGiven by IV (vein) | Procedure or surgery | Part 1 (dose escalation), Part 2 (dose expansion) |
Primary outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5
Time frame: through study completion; an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sattva Neelapu, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JV-213 and Leukapheresis in people with Lymphomas and B-cell Lymphomas, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sattva Neelapu, MD ((713) 563-3429, sneelapu@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5 (time frame: through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.