A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
- Conditions
- Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
- Registration Number
- NCT06256484
- Lead Sponsor
- Atara Biotherapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria:<br><br> - Histologically confirmed, R/R, B-cell NHL according to the 2022 revision of the<br> World Health Organization classification of lymphoid neoplasms [Alaggio 2022]<br> defined as any of the following:<br><br> 1. LBCL<br><br> 2. FL Grade 3b<br><br> 3. MCL<br><br> - The following criteria apply for details of prior treatment/therapy: R/R to at least<br> 2 lines of therapy; if the most recent line of therapy was autologous hematologic<br> cell transplant (HCT), relapse within 12 months of the transplant.<br><br> - Measurable disease by scan (diagnostic positron emission tomography-positive and/or<br> computed tomography-measurable) as per Lugano Classification [Cheson 2014]. Magnetic<br> resonance imaging may be used when computed tomography with contrast is<br> contraindicated or when mandated by local practice.<br><br> - If sufficient archival material is not available from the latest relapse, a new<br> tumor biopsy is required any time during screening, prior to conditioning<br> chemotherapy.<br><br> - Participants who have received prior CD19-directed therapy as the prior line of<br> therapy:<br><br> 1. must have achieved either a CR or partial response as a best response and<br> maintained the response for = 3 months after receiving CD19-directed treatment,<br> and<br><br> 2. must still have CD19+ disease as determined by a local laboratory.<br><br> - Eastern Cooperative Oncology Group performance status = 2<br><br> - Adequate organ function<br><br> - Written informed consent as per protocol.<br><br> - Participants are able to commit to the inpatient portion of the study, encompassing<br> conditioning (if per the institution's standard practice), and frequent monitoring<br> during Days 1-15, as well as remain within 1 hour travel time of the clinical site<br> for 28 days after each infusion.<br><br>Exclusion Criteria:<br><br> - History of a human immunodeficiency virus infection or acute or chronic active<br> hepatitis B or C infection.<br><br> - History or presence of clinically relevant central nervous system (CNS) pathology.<br><br> - Unresolved Grade 1-2 Immune effector cell-associated neurotoxicity syndrome (ICANS)<br> or experienced Grade 3-4 ICANS from prior chimeric antigen receptor T-cell.<br><br> - Unresolved graft-versus-host disease (GvHD) or Grade 3-4 acute GvHD from any prior<br> therapy or moderate to severe chronic GvHD from any prior therapy.<br><br> - History of any one of the following cardiovascular conditions: class III or IV heart<br> failure as defined by the New York Heart Association [The Criteria Committee of the<br> New York Heart Association 1994], cardiac angioplasty or stenting, myocardial<br> infarction, unstable angina, or other clinically meaningful cardiac disease, within<br> the past 6 months of study informed consent.<br><br> - History of malignancies, other than R/R NHL, unless the participant has been<br> disease-free for = 1 year (certain noninvasive malignancies are allowed).<br><br> - Active primary, CNS-only, or systemic plus CNS involvement by lymphoma, unless the<br> CNS involvement has been effectively treated.<br><br> - Active autoimmune disorders or inflammatory conditions that require systemic<br> immunosuppressive therapies, including therapeutic doses of steroids.<br><br> - Has received prior allogeneic HCT or prior solid organ transplant.<br><br> - Systemic bacterial, viral, fungal, or other infection that is untreated or<br> unresponsive to appropriate treatment (or requires IV antibiotics at enrollment);<br> participants must be afebrile for = 48 hours. Prophylactic antibiotics, antivirals,<br> and antifungals are permitted.<br><br> - Concurrent serious uncontrolled or unresolved medical condition, including any<br> laboratory abnormality or psychiatric illness.<br><br> - The following therapies within defined periods prior to the conditioning regimen:<br> therapeutic doses of corticosteroids (> 0.5 mg/kg/day of prednisone or equivalent),<br> lymphodepleting chemotherapeutic agents, live attenuated vaccines, prior systemic<br> cancer therapy, investigational agents, including approved drugs being used off<br> label, autologous HCT, donor lymphocyte infusions, radiation, alemtuzumab.<br><br> - Female who is breastfeeding or pregnant.<br><br> - Inability or unwillingness to comply with study procedures.<br><br> - Unwilling to use protocol specified contraceptive methods.<br><br> - Life expectancy of = 8 weeks.<br><br> - For participants being considered for retreatment: had a DLT with prior ATA3219<br> dose.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence and Severity of Treatment-emergent Adverse Events (TEAEs);Incidence and Severity of Adverse Events of Special Interest (AESIs);Number of Participants With Clinically Significant Changes in Laboratory Parameters;Incidence of Dose-limiting Toxicities (DLTs);Maximum Tolerated dose (MTD);Recommended Phase 2 Dose (RP2D)
- Secondary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) of ATA3219;Time to Reach Cmax of ATA3219;Partial Area Under the Curve (pAUC) of ATA3219;Last Observed Plasma Concentration (Clast) of ATA3219;Time of Clast of ATA3219;Terminal Half-life (T1/2) of ATA3219;Objective Response Rate (ORR);Complete Response Rate (CRR);Time-to-response (TTR);Duration of Response (DOR);Progression-free Survival (PFS);Overall Survival (OS)