First-in-human Single Agent Study of SAR442257 in RRMM and RR-NHL

Inclusion Criteria

• •Participant must be at least 18 years of age or of the country's legal age of majority if the legal age is \>18 years old, at the time of signing the informed consent.
• •Life expectancy of at least 12 weeks. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
• •RRMM patients:
• •must have received at least 3 prior lines of therapy including proteasome inhibitor (PI), immunomodulatory agent (IMiD), and anti-CD38 mAb;
• •and must be refractory to anti-CD38 antibody (eg, daratumumab or isatuximab), characterized by progression within 60 days of the last dose of anti-CD38, regardless of which line it was given; and must be either relapsed or refractory to all established therapies with known clinical benefit in RRMM where approved and available, or are intolerant to those established therapies; based upon investigator's clinical judgement.
• •and must not be candidates for regimens known to provide clinical benefit based upon investigator's clinical judgement.
• •Patients with RRMM must have measurable disease as per the following:
• •Serum M protein ≥0.5 g/dL (≥5 g/L), or
• •Urine M protein ≥200 mg/24 hours, or
• •Serum free light chain (FLC) assay: involved FLC assay ≥10 mg/dL and an abnormal serum FLC ratio (\<0.26 or \>1.65).
• •Patients with RR-NHL must be relapsed or refractory to all established therapies with known clinical benefit where approved and available, or are intolerant to those established therapies; based upon investigator's clinical judgement.
• •Patients with RR-NHL must have measurable disease of at least one lesion ≥1.5 cm as documented by computed tomography (CT) scan, including the following subtype of disease:
• •Diffuse large B-cell lymphoma (DLBCL).
• •HGBCL with MYC and/or BCL2 and/or BCL6 rearrangement or HGBCL NOS,
• •transformed follicular lymphoma (tFL),
• •follicular lymphoma (FL),
• •mantle cell lymphoma (MCL),
• •marginal zone lymphoma (MZL),
• •lymphoplasmacytic lymphoma,
• •small lymphocytic lymphoma (SLL). Patients with RR-NHL subtype T cell lymphoma (TCL) including the following subtype of disease: Nodal peripheral TCL including angio-immunoblastic TCL (AITL), anaplastic large cell lymphoma (ALCL), adult T cell leukemia-lymphoma, and peripheral TCL NOS (not otherwise specified). Peripheral TCL of the innate immune system: breast implant ALCL, extranodal NK/TCL, enteropathy associated TCL, monomorphic epitheliotropic intestinal TCL, and hepatosplenic TCL. histopathologically confirmed mycosis fungoides or Sézary syndrome (cutaneous T cell lymphoma \[CTCL\] stage IIB or greater according to the European Organization for Research and Treatment of Cancer/International Society for Cutaneous Lymphomas \[EORTC-ISCL\] consensus classification) at study entry with progressive, persistent, or recurrent disease who have no available remaining standard therapeutic options (ie, refractory) as determined by the Investigator.
• •Patients with lymphoma must have availability of lymphoma tissue for biomarker testing: either archived tissue or a fresh biopsy as a part of screening. On-treatment biopsy (Cycle 2 or beyond) is also expected if disease location is in a superficial lymph node. For post-CAR-T patients a fresh LN biopsy is expected if in a superficial node. For these patients tissue materials should be made available for analysis during the study. Excisional biopsy or resected tissue is required if clinically feasible; otherwise, core needle biopsy is acceptable. Fine needle aspirates are not acceptable.
• •Patients with lymphoma must have a ≥50% left ventricular ejection fraction (LVEF) and no pericardial effusion, as measured by echocardiogram (ECHO).
• •Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.