Trial record 1 of 2 for:
SC291
Study Evaluating SC291 in Subjects With r/r B-cell Malignancies (ARDENT)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05878184 |
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Recruitment Status :
Recruiting
First Posted : May 26, 2023
Last Update Posted : April 4, 2024
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Sponsor:
Sana Biotechnology
Information provided by (Responsible Party):
Sana Biotechnology
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Brief Summary:
SC291-101 is a Phase 1 study to evaluate SC291 safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non Hodgkin Lymphoma Chronic Lymphocytic Leukemia | Drug: SC291 | Phase 1 |
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 (Clinical Trial) |
| Estimated Enrollment : | 57 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | May 2, 2023 |
| Estimated Primary Completion Date : | December 2026 |
| Estimated Study Completion Date : | December 2027 |
Resource links provided by the National Library of Medicine
Drug Information
available for:
Fludarabine
| Arm | Intervention/treatment |
|---|---|
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Experimental: SC291 Plus Chemotherapy Regimen
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with SC291
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Drug: SC291
SC291 is an allogeneic CAR-T cell therapy
Other Names:
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Primary Outcome Measures :
- Evaluate safety and tolerability of SC291 [ Time Frame: 24 months ]Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities
Secondary Outcome Measures :
- 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)
- Evaluate cellular kinetics and persistence of SC291 [ Time Frame: 24 months ]Cellular kinetics-related parameters evaluated by CAR T cell copy number
- Evaluate cellular kinetics and persistence of SC291 [ Time Frame: 24 months ]Cellular kinetics related peak (Cmax) in peripheral blood
- Evaluate cellular kinetics and persistence of SC291 [ Time Frame: 24 months ]Area under the concentration time curve (AUC) in peripheral blood
- Evaluate host immunogenicity to SC291 [ Time Frame: 24 months ]Incidence of anti-CD19-directed CAR antibodies
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05878184
Contacts
| Contact: Ndidi Onwudiwe | 206 791 3731 | ardent@sana.com | |
| Contact: Barbara Metallo | ardent@sana.com |
Locations
| United States, California | |
| City of Hope | Recruiting |
| Duarte, California, United States, 91010 | |
| Contact: Sylvia Dulan sdulan@coh.org | |
| Contact: Teresa Kim teresakim@coh.org | |
| Principal Investigator: Elizabeth Budde, MD | |
| Stanford Cancer Institute | Recruiting |
| Palo Alto, California, United States, 94304 | |
| Contact: Vivian Leung vivian0@stanford.edu | |
| Principal Investigator: Saurabh Dahiya, MD | |
| United States, Georgia | |
| Northside Hospital | Recruiting |
| Atlanta, Georgia, United States, 30342 | |
| Contact: Caitlin Guzowski caitlin.guzowski@northside.com | |
| Principal Investigator: Scott Solomon, MD | |
| United States, Kansas | |
| University of Kansas Medical Center | Recruiting |
| Fairway, Kansas, United States, 66205 | |
| Contact: Aleks Kostic akostic@kumc.edu | |
| Contact: Melissa Youngberg myoungberg@kumc.edu | |
| Principal Investigator: Joseph McGuirk, MD | |
| United States, Michigan | |
| Karmanos Cancer Institute | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Grace Bae baeg@karmanos.org | |
| Contact: Sarah Park parks@karmanos.org | |
| Principal Investigator: Abhinav Deol, MD | |
| United States, Nebraska | |
| University of Nebraska Medical Center | Recruiting |
| Omaha, Nebraska, United States, 68198 | |
| Contact: Linda Chee linda.chee@unmc.edu | |
| Contact: Susan Blumel sblumel@unmc.edu | |
| Principal Investigator: Matthew Lunning, DO | |
| United States, Texas | |
| MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Swapna Johncy, MD sjjohncy@mdanderson.org | |
| Contact: Grace Balada wgwatson@mdanderson.org | |
| Principal Investigator: Sattva Neelapu, MD | |
| Australia, Victoria | |
| Peter MacCallum Cancer Centre | Recruiting |
| Melbourne, Victoria, Australia, 3000 | |
| Contact: Meg Scully Meg.scully@petermac.org | |
| Contact: Felicity McLeay felicity.mcleay@petermac.org | |
| Principal Investigator: Philip Thompson, MD | |
Sponsors and Collaborators
Sana Biotechnology
Investigators
| Study Director: | Paul Brunetta, MD | Sana Biotechnology, Inc. |
| Responsible Party: | Sana Biotechnology |
| ClinicalTrials.gov Identifier: | NCT05878184 |
| Other Study ID Numbers: |
SC291-101 |
| First Posted: | May 26, 2023 Key Record Dates |
| Last Update Posted: | April 4, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Sana Biotechnology:
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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 |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, Non-Hodgkin Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia Hematologic Diseases Leukemia, B-Cell Chronic Disease |
Disease Attributes Pathologic Processes Cyclophosphamide Fludarabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |