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New treatment option for Non-hodgkin Lymphoma
Official title CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT06026319
What this study is testing
What is CD79b-19 CAR T cells?
CD79b-19 CAR T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-hodgkin lymphoma.
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
- 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
- Phase 1: an early, usually small safety study
- Time commitment: about 2 years
- Which group you join is decided by chance.
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
- 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...
- Follicular Lymphoma (FL) grade 1, grade 2, or grade 3a 1\. R/R disease after 2 or more prior lines of systemic therapy
You likely can't join if
- for Leukapheresis for Parts A and B:
- 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...
- 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...
See the full eligibility criteria
Who can join
- 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...
- Follicular Lymphoma (FL) grade 1, grade 2, or grade 3a 1\. R/R disease after 2 or more prior lines of systemic therapy
- Marginal Zone Lymphoma (MZL) nodal of extranodal: 1\. 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.
- Prior therapy must include:
- Anthracycline or bendamustine-containing chemotherapy AND
- Anti-CD20 monoclonal antibody therapy AND
- BTKi therapy (progression does not have to be documented on BTKi).
- people must have measurable disease according to appropriate disease specific criteria.
- Adequate absolute lymphocyte count (ALC \> 100 cells/ul) within one week of apheresis.
- Adequate bone marrow function defined by absolute neutrophil count (ANC) \>1000 cells/mm3 without growth factor support (filgrastim within 7 days or pegfilgrastim within 14 days) and untransfused platelet count \>50,000...
- Left ventricular ejection fraction \> 40%
- Adequate hepatic function defined by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 × upper limit of normal (ULN) and direct bilirubin \< 1.5 × ULN.
- Adequate renal function defined by creatinine clearance \>60 ml/min using the Cockcroft-Gault formula.
- The effects of CD79b-19 CAR T cells on the developing human fetus are unknown. For this reason, women of child-bearing potential and men with partners of childbearing potential must agree to use adequate contraception...
- Ability and willingness to adhere to the study visit schedule and all protocol requirements for treatment (Initiating Lymphodepletion/Cell Infusion):
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky ≥60%, see Appendix A)
- No active, uncontrolled, systemic bacterial, viral, or fungal infection. If febrile, the patient must have negative blood cultures x48 hours at time of cell infusion AND on appropriate broad spectrum antibiotic therapy
- Oxygen saturation \>92% on room air while awake
- No additional anti-cancer therapy since leukapheresis excluding steroids at or below physiologic dosing. Infusion may be delayed by up to 5 days after completion of LD chemo, without sponsor approval, in the event that...
What rules you out
- for Leukapheresis for Parts A and B:
- 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...
- Active, uncontrolled, systemic bacterial, viral, or fungal infection.
- people with a history of class III or IV congestive heart failure or with a history of non- ischemic cardiomyopathy.
- people with unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the previous 3 months.
- people with arterial vascular disease such as history of cerebrovascular accident or peripheral vascular disease requiring therapeutic anti-coagulation.
- people with history of a new pulmonary embolism (PE) /deep vein thrombosis (DVT) within 6 months of beginning lymphodepletion requiring ongoing anticoagulation.
- people 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...
- 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...
- Prior CD19-directed cellular therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, 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 study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Boston, Massachusetts, 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.