Study Evaluating SC291 in Subjects With r/r B-cell Malignancies (ARDENT)

Trial Title: Study Evaluating SC291 in Subjects With r/r B-cell Malignancies (ARDENT)

NCT ID: NCT05878184

Condition: Non Hodgkin Lymphoma
Chronic Lymphocytic Leukemia

Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Cyclophosphamide
Fludarabine

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

Study type: Interventional

Study phase: Phase 1

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: SC291
Description: SC291 is an allogeneic CAR-T cell therapy
Arm group label: SC291 Plus Chemotherapy Regimen

Other name: Cyclophosphamide

Other name: Fludarabine

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: City of Hope

Address:
City: Duarte
Zip: 91010
Country: United States

Facility:
Name: Stanford Cancer Institute

Address:
City: Palo Alto
Zip: 94304
Country: United States

Facility:
Name: Northside Hospital

Address:
City: Atlanta
Zip: 30342
Country: United States

Facility:
Name: University of Kansas Medical Center

Address:
City: Fairway
Zip: 66205
Country: United States

Facility:
Name: Karmanos Cancer Institute

Address:
City: Detroit
Zip: 48201
Country: United States

Facility:
Name: University of Nebraska Medical Center

Address:
City: Omaha
Zip: 68198
Country: United States

Facility:
Name: MD Anderson Cancer Center

Address:
City: Houston
Zip: 77030
Country: United States

Facility:
Name: Royal Adelaide Hospital

Address:
City: Adelaide
Zip: 5000
Country: Australia

Facility:
Name: Peter MacCallum Cancer Centre

Address:
City: Melbourne
Zip: 3000
Country: Australia

Facility:
Name: Linear Clinical Research Ltd

Address:
City: Nedlands
Zip: 6009
Country: Australia

Start date: May 2, 2023

Completion date: November 4, 2038

Lead sponsor:
Agency: Sana Biotechnology
Agency class: Industry

Source: Sana Biotechnology

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05878184