Is NCT06026319 recruiting in Boston, MA?

Yes, NCT06026319 is currently recruiting participants at its Boston, MA location. This non-hodgkin lymphoma clinical trial is actively enrolling qualified participants.

How do I join the non-hodgkin lymphoma clinical trial in Boston?

To join this clinical trial in Boston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Boston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Non-hodgkin Lymphoma Clinical Trial in Boston, MA

About This Non-hodgkin Lymphoma Study in Boston

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

Sponsor: Marcela V. Maus, M.D.,Ph.D.

Who Can Participate

Inclusion Criteria

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 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).

Subjects 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 mm3.

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 (hormonal or barrier method of birth control; abstinence) prior to leukapheresis. Women of childbearing potential are required to use adequate contraception for up to 1 year post CD79b-19 CAR T cell infusion. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men with partners of childbearing potential treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and until 6 months after last CD79b-19 CAR T cells administration.

Ability and willingness to adhere to the study visit schedule and all protocol requirements Inclusion Criteria 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 these issues resolve in that time frame. The above criteria need to be met to start treatment (for both initiation of lymphodepletion and cell infusion).

Exclusion Criteria

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 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. Additional Exclusion Criteria for Leukapheresis for Part B, Arm B.2:

Prior CD19-directed cellular therapy.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT06026319) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Non-hodgkin Lymphoma Treatment Options in Boston, MA

If you're searching for non-hodgkin lymphoma treatment options in Boston, MA, this clinical trial (NCT06026319) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced non-hodgkin lymphoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all non-hodgkin lymphoma clinical trials near you to find additional studies recruiting in your area.

Non-hodgkin Lymphoma Clinical Trial in Boston, MA

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