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

April 3, 2024 updated by: Sana Biotechnology

A Phase 1 Study Evaluating SC291, a Hypoimmune, Allogeneic CD19-directed CAR T Cell Therapy, in Relapsed and/or Refractory B-cell Malignancies (ARDENT)

SC291-101 is a Phase 1 study to evaluate SC291 safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

57

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elizabeth Budde, MD
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Cancer Institute
        • Principal Investigator:
          • Saurabh Dahiya, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30342
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Medical Center
        • Principal Investigator:
          • Joseph McGuirk, MD
        • Contact:
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48201
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University Of Nebraska Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Matthew Lunning, DO
    • Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SC291 Plus Chemotherapy Regimen
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with SC291
Drug: SC291
SC291 is an allogeneic CAR-T cell therapy
Other Names:
  • Cyclophosphamide
  • Fludarabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate safety and tolerability of SC291
Time Frame: 24 months
Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate preliminary anti-tumor activity of SC291
Time Frame: 24 months
Preliminary anti-tumor activity: Proportion of subjects with an objective response (including partial response or complete response)
24 months
Evaluate cellular kinetics and persistence of SC291
Time Frame: 24 months
Cellular kinetics-related parameters evaluated by CAR T cell copy number
24 months
Evaluate host immunogenicity to SC291
Time Frame: 24 months
Incidence of anti-CD19-directed CAR antibodies
24 months
Evaluate cellular kinetics and persistence of SC291
Time Frame: 24 months
Cellular kinetics related peak (Cmax) in peripheral blood
24 months
Evaluate cellular kinetics and persistence of SC291
Time Frame: 24 months
Area under the concentration time curve (AUC) in peripheral blood
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sana Biotechnology

Investigators

  • Study Director: Paul Brunetta, MD, Sana Biotechnology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 28, 2023

First Submitted That Met QC Criteria

May 17, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SC291-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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