Phase
Condition
Mantle Cell Lymphoma
Inflammation
Lymphoma
Treatment
ATA3219
Clinical Study ID
Ages 18-120 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Histologically confirmed, R/R, B-cell NHL according to the 2022 revision of theWorld Health Organization classification of lymphoid neoplasms [Alaggio 2022]defined as any of the following:
LBCL
FL Grade 3b
MCL
The following criteria apply for details of prior treatment/therapy: R/R to at least 2 lines of therapy; if the most recent line of therapy was autologous hematologiccell transplant (HCT), relapse within 12 months of the transplant.
Measurable disease by scan (diagnostic positron emission tomography-positive and/orcomputed tomography-measurable) as per Lugano Classification [Cheson 2014]. Magneticresonance imaging may be used when computed tomography with contrast iscontraindicated or when mandated by local practice.
If sufficient archival material is not available from the latest relapse, a newtumor biopsy is required any time during screening, prior to conditioningchemotherapy.
Participants who have received prior CD19-directed therapy as the prior line oftherapy:
must have achieved either a CR or partial response as a best response andmaintained the response for ≥ 3 months after receiving CD19-directed treatment,and
must still have CD19+ disease as determined by a local laboratory.
Eastern Cooperative Oncology Group performance status ≤ 2
Adequate organ function
Written informed consent as per protocol.
Participants are able to commit to the inpatient portion of the study, encompassingconditioning (if per the institution's standard practice), and frequent monitoringduring Days 1-15, as well as remain within 1 hour travel time of the clinical sitefor 28 days after each infusion.
Exclusion
Exclusion Criteria:
History of a human immunodeficiency virus infection or acute or chronic activehepatitis B or C infection.
History or presence of clinically relevant central nervous system (CNS) pathology.
Unresolved Grade 1-2 Immune effector cell-associated neurotoxicity syndrome (ICANS)or experienced Grade 3-4 ICANS from prior chimeric antigen receptor T-cell.
Unresolved graft-versus-host disease (GvHD) or Grade 3-4 acute GvHD from any priortherapy or moderate to severe chronic GvHD from any prior therapy.
History of any one of the following cardiovascular conditions: class III or IV heartfailure as defined by the New York Heart Association [The Criteria Committee of theNew York Heart Association 1994], cardiac angioplasty or stenting, myocardialinfarction, unstable angina, or other clinically meaningful cardiac disease, withinthe past 6 months of study informed consent.
History of malignancies, other than R/R NHL, unless the participant has beendisease-free for ≥ 1 year (certain noninvasive malignancies are allowed).
Active primary, CNS-only, or systemic plus CNS involvement by lymphoma, unless theCNS involvement has been effectively treated.
Active autoimmune disorders or inflammatory conditions that require systemicimmunosuppressive therapies, including therapeutic doses of steroids.
Has received prior allogeneic HCT or prior solid organ transplant.
Systemic bacterial, viral, fungal, or other infection that is untreated orunresponsive to appropriate treatment (or requires IV antibiotics at enrollment);participants must be afebrile for ≥ 48 hours. Prophylactic antibiotics, antivirals,and antifungals are permitted.
Concurrent serious uncontrolled or unresolved medical condition, including anylaboratory abnormality or psychiatric illness.
The following therapies within defined periods prior to the conditioning regimen:therapeutic doses of corticosteroids (> 0.5 mg/kg/day of prednisone or equivalent),lymphodepleting chemotherapeutic agents, live attenuated vaccines, prior systemiccancer therapy, investigational agents, including approved drugs being used offlabel, autologous HCT, donor lymphocyte infusions, radiation, alemtuzumab.
Female who is breastfeeding or pregnant.
Inability or unwillingness to comply with study procedures.
Unwilling to use protocol specified contraceptive methods.
Life expectancy of ≤ 8 weeks.
For participants being considered for retreatment: had a DLT with prior ATA3219dose.
Study Design
Study Description
Connect with a study center
Princess Alexandra Hospital
Woolloongabba, Queensland 4102
AustraliaSite Not Available
Fiona Stanley Hospital
Murdoch, Western Australia 6150
AustraliaSite Not Available
AdventHealth Cancer Institute
Orlando, Florida 32804
United StatesSite Not Available
Norton Cancer Institute
Louisville, Kentucky 40207
United StatesActive - Recruiting
Norton Cancer Institute - Saint Matthews
Louisville, Kentucky 40207
United StatesSite Not Available
Sidney Kimmel Cancer Center - Jefferson Health
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
University of Virgina
Charlottesville, Virginia 22908
United StatesSite Not Available

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