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

NCT05773040 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2022-0938NCI-2023-02055
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphomas; B-cell Lymphomas

Keywords

B-cell lymphoma, CD79b, CAR T cell therapy

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5

  through study completion; an average of 1 year

Study Arms (2)

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.

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.

Drug: JV-213; Procedure: Leukapheresis

Interventions

JV-213 DRUG

Given by (IV) vein

Part 1 (dose escalation); Part 2 (dose expansion)

Leukapheresis PROCEDURE

Given by IV (vein)

Part 1 (dose escalation); Part 2 (dose expansion)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify 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 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.
• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

The University of Texas M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Lymphoma; Lymphoma, B-Cell

Interventions

Leukapheresis

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Cytapheresis; Biological Therapy; Therapeutics; Blood Component Removal; Leukocyte Reduction Procedures; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques

Study Officials

• Sattva Neelapu, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sattva Neelapu, MD

CONTACT

(713) 563-3429; sneelapu@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 17, 2023
• Study Start: April 14, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)