Chronic Lymphocytic Leukemia, Non Hodgkin Lymphoma
Conditions
Keywords
Large B cell lymphoma, CAR T Cell Therapy, Mantle cell lymphoma, Indolent follicular lymphoma, Marginal zone lymphoma, High-grade B cell lymphoma, Primary mediastinal B cell lymphoma, Diffuse large B cell lymphoma, Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Allogeneic, Hypoimmune, CD19
Brief summary
SC291-101 is a Phase 1 study to evaluate SC291 safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.
Detailed description
This is an open-label, single arm, Phase 1, first-in-human (FIH) study to evaluate the safety and tolerability of SC291 administered intravenously (IV) following a standard lymphodepleting chemotherapy regimen of cyclophosphamide and fludarabine in subjects with NHL or CLL who have received two or more prior systemic treatments per standard of care (or after autologous stem cell transplant \[ASCT\] for NHL). This study will be conducted in 2 parts. Phase 1a: dose finding using a 3+3 design in subjects with NHL or CLL. Phase 1b: dose expansion to further evaluate safety and efficacy at the RP2D in subjects with LBCL and CLL.
Interventions
DRUGSC291
SC291 is an allogeneic CAR-T cell therapy
Sponsors
Sana Biotechnology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subjects aged 18-80 years at the time of signing informed consent. * Diagnosis of NHL (WHO 2016 criteria) or CLL (iwCLL criteria), including: * Large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise - - specified (including DLBCL arising from indolent lymphoma), primary mediastinal large -- - B-cell lymphoma, high grade B-cell lymphoma, follicular lymphoma grade 3B * Follicular lymphoma (dose escalation only except for follicular lymphoma grade 3B) * Marginal zone lymphoma (dose escalation only) * Mantle cell lymphoma (dose escalation only) * CLL or SLL * Relapsed/refractory disease after at least 2 prior systemic regimens per standard of care or after autologous stem cell transplant * ECOG performance status of 0 or 1. * At least one measurable lesion per Lugano Classification (NHL); CLL subjects must meet iwCLL treatment criteria * Life expectancy ≥12 weeks
Exclusion criteria
* Prior anti-CD19 therapy including CD19-directed CAR T treatment or other CD19-directed antibody or cell therapy (e.g., NK cell). (Part 2 dose expansion only - prior approved CD19-directed CAR T therapy required) * History of primary central nervous system (CNS) lymphoma or presence of CNS metastases * Systemic anticancer therapy (including platinum-based chemotherapies and I/O therapies) or radiotherapy within 14 days of SC291 (28 days for biologics) * Autologous HSCT within 6 weeks of treatment with SC291 (or allogeneic HSCT at any time). * Active autoimmune disease or any other diseases requiring immunosuppressive therapy or corticosteroid therapy (defined as \>20 mg/day prednisone or equivalent). * History or presence of cardiac or CNS disorders as defined in the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate safety and tolerability of SC291 | 24 months | Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate preliminary anti-tumor activity of SC291 | 24 months | Preliminary anti-tumor activity: Proportion of subjects with an objective response (including partial response or complete response) |
| Evaluate cellular kinetics and persistence of SC291 | 24 months | Cellular kinetics-related parameters evaluated by CAR T cell copy number |
| Evaluate host immunogenicity to SC291 | 24 months | Incidence of anti-CD19-directed CAR antibodies |
Countries
Australia, United States
Outcome results
None listed