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

Phase 1
Active, not recruiting
Conditions
Non Hodgkin Lymphoma
Chronic Lymphocytic Leukemia
Interventions
Drug: SC291
Registration Number
NCT05878184
Lead Sponsor
Sana Biotechnology
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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
16
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 β‰₯12 weeks
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
SC291 Plus Chemotherapy RegimenSC291A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with SC291
Primary Outcome Measures
NameTimeMethod
Evaluate safety and tolerability of SC29124 months

Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities

Secondary Outcome Measures
NameTimeMethod
Evaluate preliminary anti-tumor activity of SC29124 months

Preliminary anti-tumor activity: Proportion of subjects with an objective response (including partial response or complete response)

Evaluate cellular kinetics and persistence of SC29124 months

Area under the concentration time curve (AUC) in peripheral blood

Evaluate host immunogenicity to SC29124 months

Incidence of anti-CD19-directed CAR antibodies

Trial Locations

Locations (10)

City of Hope

πŸ‡ΊπŸ‡Έ

Duarte, California, United States

Stanford Cancer Institute

πŸ‡ΊπŸ‡Έ

Palo Alto, California, United States

Northside Hospital

πŸ‡ΊπŸ‡Έ

Atlanta, Georgia, United States

University of Kansas Medical Center

πŸ‡ΊπŸ‡Έ

Fairway, Kansas, United States

Karmanos Cancer Institute

πŸ‡ΊπŸ‡Έ

Detroit, Michigan, United States

University of Nebraska Medical Center

πŸ‡ΊπŸ‡Έ

Omaha, Nebraska, United States

MD Anderson Cancer Center

πŸ‡ΊπŸ‡Έ

Houston, Texas, United States

Royal Adelaide Hospital

πŸ‡¦πŸ‡Ί

Adelaide, South Australia, Australia

Peter MacCallum Cancer Centre

πŸ‡¦πŸ‡Ί

Melbourne, Victoria, Australia

Linear Clinical Research Ltd

πŸ‡¦πŸ‡Ί

Nedlands, Western Australia, Australia

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