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

Primary Purpose

Non Hodgkin Lymphoma, Chronic Lymphocytic Leukemia

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
SC291
Sponsored by
Sana Biotechnology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Hodgkin Lymphoma focused on measuring 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

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female subjects aged 18-75 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

Sites / Locations

  • City of HopeRecruiting
  • Stanford Cancer InstituteRecruiting
  • University of Kansas Medical CenterRecruiting
  • Karmanos Cancer InstituteRecruiting
  • MD Anderson Cancer CenterRecruiting
  • Peter MacCallum Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SC291 Plus Chemotherapy Regimen

Arm Description

A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with SC291

Outcomes

Primary Outcome Measures

Evaluate safety and tolerability of SC291
Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities

Secondary Outcome Measures

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

Full Information

First Posted
April 28, 2023
Last Updated
August 29, 2023
Sponsor
Sana Biotechnology
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1. Study Identification

Unique Protocol Identification Number
NCT05878184
Brief Title
Study Evaluating SC291 in Subjects With r/r B-cell Malignancies (ARDENT)
Official Title
A Phase 1 Study Evaluating SC291, a Hypoimmune, Allogeneic CD19-directed CAR T Cell Therapy, in Relapsed and/or Refractory B-cell Malignancies (ARDENT)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2023 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sana Biotechnology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SC291 Plus Chemotherapy Regimen
Arm Type
Experimental
Arm Description
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with SC291
Intervention Type
Drug
Intervention Name(s)
SC291
Other Intervention Name(s)
Cyclophosphamide, Fludarabine
Intervention Description
SC291 is an allogeneic CAR-T cell therapy
Primary Outcome Measure Information:
Title
Evaluate safety and tolerability of SC291
Description
Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Evaluate preliminary anti-tumor activity of SC291
Description
Preliminary anti-tumor activity: Proportion of subjects with an objective response (including partial response or complete response)
Time Frame
24 months
Title
Evaluate cellular kinetics and persistence of SC291
Description
Cellular kinetics-related parameters evaluated by CAR T cell copy number
Time Frame
24 months
Title
Evaluate cellular kinetics and persistence of SC291
Description
Cellular kinetics related peak (Cmax) in peripheral blood
Time Frame
24 months
Title
Evaluate cellular kinetics and persistence of SC291
Description
Area under the concentration time curve (AUC) in peripheral blood
Time Frame
24 months
Title
Evaluate host immunogenicity to SC291
Description
Incidence of anti-CD19-directed CAR antibodies
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects aged 18-75 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ndidi Onwudiwe
Phone
206 791 3731
Email
ardent@sana.com
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Metallo
Email
ardent@sana.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hosein Kouros-Mehr, MD
Organizational Affiliation
Sana Biotechnology
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvia Dulan
Email
sdulan@coh.org
First Name & Middle Initial & Last Name & Degree
Teresa Kim
Email
teresakim@coh.org
First Name & Middle Initial & Last Name & Degree
Elizabeth Budde, MD
Facility Name
Stanford Cancer Institute
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vivian Leung
Email
vivian0@stanford.edu
First Name & Middle Initial & Last Name & Degree
Saurabh Dahiya, MD
Facility Name
University of Kansas Medical Center
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleks Kostic
Email
akostic@kumc.edu
First Name & Middle Initial & Last Name & Degree
Melissa Youngberg
Email
myoungberg@kumc.edu
First Name & Middle Initial & Last Name & Degree
Joseph McGuirk, MD
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Bae
Email
baeg@karmanos.org
First Name & Middle Initial & Last Name & Degree
Sarah Park
Email
parks@karmanos.org
First Name & Middle Initial & Last Name & Degree
Abhinav Deol, MD
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Swapna Johncy, MD
Email
sjjohncy@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Grace Balada
Email
wgwatson@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Sattva Neelapu, MD
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meg Scully
Email
Meg.scully@petermac.org
First Name & Middle Initial & Last Name & Degree
Felicity McLeay
Email
felicity.mcleay@petermac.org
First Name & Middle Initial & Last Name & Degree
Philip Thompson, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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