Study of IMPT-314 in R/R Aggressive B-cell NHL

Inclusion Criteria:

Age 18 years or older
Willing and able to provide written informed consent

Histologically confirmed aggressive NHL, including the following types defined by the World Health Organization (WHO) 2017:

DLBCL
DLBCL arising from follicular lymphoma (Transformed FL)
Primary mediastinal (thymic) large B-cell lymphoma
High-grade large B-cell lymphoma with or without MYC and BCL2 and/or BCL6 rearrangement
Grade 3b follicular lymphoma/Large cell follicular lymphoma

Received at least 1 prior line of therapy. Prior therapy must have included:

Anti-CD20 monoclonal antibody
An anthracycline containing chemotherapy regimen
Participants with TFL must have received at least one of their prior lines of therapy after transformation to DLBCL

Relapsed or refractory disease, defined by the following:

Disease progression after last regimen (including salvage therapy after autologous stem cell transplantation [ASCT]). In participants who have only received front-line therapy, progression should be ≤12 months of initiating first-line therapy.
In patients who received two or more lines of therapy, refractory disease is defined as failure to achieve a CR to last line of therapy (including CAR T and/or salvage therapy).
In patients who received one line of therapy, refractory disease is defined as failure to achieve at least a PR after at least 4 cycles of therapy
At least 1 measurable lesion (the Lugano classification). Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Absolute neutrophil count (ANC) ≥ 1000/uL

Other protocol-defined criteria apply.

Exclusion Criteria:

History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast) unless disease-free for at least 3 years. Participants who have received therapy for a prior malignancy within the prior 3 years, e.g., in the adjuvant setting, are not excluded
Active central nervous system (CNS) involvement by malignancy on magnetic resonance imaging (MRI) or by lumbar puncture. Participants with prior evidence of brain metastasis successfully treated at least 8 weeks prior to enrollment will not be excluded for participation if CNS disease is deemed stable at the time of study enrolment
History of cardiac lymphoma involvement
Ongoing or impending oncologic emergency (e.g., tumor mass effect, tumor lysis syndrome)

Received the following therapies in the specified time frame prior to enrollment/leukapheresis

Any systemic therapy within 2 weeks

Any systemic inhibitory/stimulatory immune checkpoint molecule therapy within 3 half-lives prior to enrollment (e.g., ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-

1BB agonists)

Fludarabine within 12 weeks
Alemtuzumab, bendamustine or antithymocyte globuline (ATG) within 6 months
Any T cell engager/bispecific antibody therapy such as CD20/CD3 or CD19/CD3 bispecific antibodies within 4 weeks
Any experimental therapy within 4 weeks or 5 half-lives (whichever is shorter)
Received radiation therapy within 3 weeks prior to enrollment
Experiencing non-hematologic toxicities due to prior therapy (stable and recovered to grade ≤ 1 or non- clinically significant toxicities such as alopecia are allowed)
History of allogeneic stem cell or solid organ transplantation
Receipt of autologous stem cell transplantation within 6 weeks prior to enrollment
History of prior genetically modified T cell therapy other than a product targeting CD19 with an FMC63-based CAR (e.g., axicabtagene ciloleucel (axi-cel, YESCARTA®), tisagenlecleucel (tisa-cel, KYMRIAH®), or lisocabtagene maraleucel (liso-cel, BREYANZI®). For all other CAR T cell therapy treatments, discussion with the Sponsor's Medical Monitor is required
Primary immunodeficiency
History of autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years. Participants who have other autoimmune condition(s) considered to be associated with underlying malignancy may be enrolled in the study after discussion with and approval of the Medical Monitor.

Other protocol-defined criteria apply.