CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma
A Phase I Study of Bivalent CD79b and CD19 Directed CAR T Cells in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma
1 other identifier
interventional
24
1 country
1
Brief Summary
This research study involves the study of CD79b-19 CAR T cells for treating people with relapsed/refractory Non-Hodgkin Lymphoma and to understand the side effects when treated with CD79b-19 CAR T cells. This research study involves the study drugs:
- CD79b-19 CAR T cells
- Fludarabine and Cyclophosphamide: Standardly used chemotherapy drugs as part of lymphodepleting process
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2023
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2023
CompletedFirst Posted
Study publicly available on registry
September 7, 2023
CompletedStudy Start
First participant enrolled
October 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
March 16, 2026
March 1, 2026
3.2 years
August 30, 2023
March 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of adverse events (AEs)
Study-related adverse events (AEs) will be listed and tabulated by type and study cohort. The rate of AEs in all infused patients, both within study cohorts and overall, will be calculated and reported with exact 95% confidence intervals. A separate safety analysis will report similar information within patients infused at the target dose of 1x108 or 3x108 CD79b-19 CAR T cells.
From Day 0 to 2 years post-treatment
Incidence of Dose Limiting Toxicity (DLT)
Dose-limiting toxicities will be listed and tabulated by type and study cohort.
From Day 0 to 2 years post-treatment
Secondary Outcomes (3)
Overall Response Rate (ORR)
1 month, 6 months, 12 months, and 24 months after CD79b-19 CAR T cells treatment
Overall Survival (OS)
1 month, 6 months, 12 months, and 24 months after CD79b-19 CAR T cells treatment
Progression Free Survival (PFS)
1 month, 6 months, 12 months, and 24 months after CD79b-19 CAR T cells treatment
Study Arms (1)
CD79b-19 CAR T cells
EXPERIMENTALPrior to receiving CD79b-19 CAR T cells, participants will undergo two preparatory processes: * Leukapheresis: During Week -3 white blood cells will be collected. * Lymphodepletion: On days, -5 to -3 participants will receive 3 days of chemotherapy to decrease the number of lymphocytes CD79b-19 CAR T cells will be administered intravenously on day 0 only. The dose you will receive will depend on the number of participants who have been enrolled prior and how well the dose was tolerated. The CD79b-19 CAR T cells will be administered over approximately 1 hour.
Interventions
Eligibility Criteria
You may qualify if:
- Voluntarily sign informed consent form(s)
- ≥18 years of age at the time of signing informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky ≥60%, see Appendix A)
- Diagnosis of histologically or cytologically confirmed relapsed/refractory (R/R) Non Hodgkins lymphoma as defined as one of the following (Note: only patients with indolent lymphomas that warrant treatment should be treated, this will include those with local symptoms due to progressive/bulky disease, compromised organ function, B symptoms, extra-nodal disease, cytopenias from marrow involvement and/or in the opinion of the treating physician believe that any of the above symptoms or potentially life threatening involvement will occur will be treated):
- Follicular Lymphoma (FL) grade 1, grade 2, or grade 3a
- \. R/R disease after 2 or more prior lines of systemic therapy
- Marginal Zone Lymphoma (MZL) nodal of extranodal:
- \. R/R disease after 2 or more prior lines of systemic therapy
- Diffuse large B-cell lymphoma (DLBCL), including transformed follicular lymphoma (FL), primary mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBCL) and grade 3b Follicular Lymphoma (FL).
- R/R disease after 2 or more prior lines of therapy OR
- Relapsed following autologous SCT, OR
- Ineligible for autologous SCT.
- Mantle cell lymphoma
- R/R disease as defined by disease progression after last regimen (including autologous SCT) OR
- Refractory disease as defined as failure to achieve a CR to last regimen.
- +18 more criteria
You may not qualify if:
- Treatment with an any investigational cellular therapy within 8 weeks prior to apheresis.
- Any systemic anti-cancer therapy within 1 weeks or 5 half-lives of leukapheresis, whichever is shortest, excluding steroids (prednisone) at or below physiologic dosing (5mg).
- No bispecific T cell engagers within 6 months of leukapheresis.
- No bendamustime within 6 months of leukapheresis.
- Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above physiologic dosing). Intermittent topical, inhaled, or intranasal corticosteroids are allowed.
- Ongoing systemic immunosuppression for acute and/or chronic GVH as a result of previous allogeneic bone marrow transplant and at least 12 weeks out from prior allogeneic SCT.
- Presence of active CNS disease
- Significant co-morbid condition or disease which in the judgment of the Principal Investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, and/or recent significant traumatic injury.
- Active, uncontrolled, systemic bacterial, viral, or fungal infection.
- Subjects with a history of class III or IV congestive heart failure or with a history of non- ischemic cardiomyopathy.
- Subjects with unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the previous 3 months.
- Subjects with arterial vascular disease such as history of cerebrovascular accident or peripheral vascular disease requiring therapeutic anti-coagulation.
- Subjects with history of a new pulmonary embolism (PE) /deep vein thrombosis (DVT) within 6 months of beginning lymphodepletion requiring ongoing anticoagulation.
- Subjects with second malignancies if the second malignancy has required therapy in the last 3 years or is not in complete remission; exceptions to this criterion include successfully treated non-metastatic basal cell or squamous cell skin carcinoma, or prostate cancer that does not require therapy other than hormonal therapy.
- Pregnant or lactating women. Pregnant women are excluded from this study because CAR-79b-19 T cell drug product is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-79b-19 T cell drug product, breastfeeding should be discontinued if the mother is treated with CAR-79b-19 T cell drug product.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Frigault, MD
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor-Investigator
Study Record Dates
First Submitted
August 30, 2023
First Posted
September 7, 2023
Study Start
October 26, 2023
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2028
Last Updated
March 16, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Partners Innovations team at http://www.partners.org/innovation
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.