Save

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

PHASE1RECRUITING

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

Simpliy with AI

Study details:

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.

Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

Simplify with AI

Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-05-02

Primary completion: 2026-12-01

Study completion finish: 2027-12-01

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT05878184

Intervention or treatment

DRUG: SC291

Conditions

• Non Hodgkin Lymphoma
• Chronic Lymphocytic Leukemia

Condition: Non Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
DRUG: SC291
Adelaide, South Australia, Australia and more
Sponsor: Sana Biotechnology

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Royal Adelaide Hospital

Research sites nearby

Select from list below to view details:

Royal Adelaide Hospital
Adelaide, South Australia, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia

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?

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

What is the study measuring?

Primary outcome

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

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Evaluate preliminary anti-tumor activity of SC291	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	Cellular kinetics-related parameters evaluated by CAR T cell copy number	24 months
Evaluate cellular kinetics and persistence of SC291	Cellular kinetics related peak (Cmax) in peripheral blood	24 months
Evaluate cellular kinetics and persistence of SC291	Area under the concentration time curve (AUC) in peripheral blood	24 months
Evaluate host immunogenicity to SC291	Incidence of anti-CD19-directed CAR antibodies	24 months

Frequently Asked Questions

Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

No questions submitted. Be the first to ask a question!

You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Study Evaluating SC291 in Subjects with R/r B-cell Malignancies (ARDENT)