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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05878184




Registration number
NCT05878184
Ethics application status
Date submitted
28/04/2023
Date registered
26/05/2023
Date last updated
4/04/2024

Titles & IDs
Public title
Study Evaluating SC291 in Subjects With r/r B-cell Malignancies (ARDENT)
Scientific 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)
Secondary ID [1] 0 0
SC291-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Hodgkin Lymphoma 0 0
Chronic Lymphocytic Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SC291

Experimental: SC291 Plus Chemotherapy Regimen - A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with SC291


Treatment: Drugs: SC291
SC291 is an allogeneic CAR-T cell therapy
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate safety and tolerability of SC291
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
Evaluate preliminary anti-tumor activity of SC291
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Evaluate cellular kinetics and persistence of SC291
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
Evaluate cellular kinetics and persistence of SC291
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Evaluate cellular kinetics and persistence of SC291
Timepoint [4] 0 0
24 months
Secondary outcome [5] 0 0
Evaluate host immunogenicity to SC291
Timepoint [5] 0 0
24 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
57
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Nebraska
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sana Biotechnology
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
SC291-101 is a Phase 1 study to evaluate SC291 safety and tolerability, anti-tumor activity,
cellular kinetics, immunogenicity, and exploratory biomarkers.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05878184
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Brunetta, MD
Address 0 0
Sana Biotechnology, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ndidi Onwudiwe
Address 0 0
Country 0 0
Phone 0 0
206 791 3731
Fax 0 0
Email 0 0
ardent@sana.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05878184