Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05878184
Ethics application status
Date submitted
28/04/2023
Date registered
26/05/2023

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
Not applicable
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
Active, not 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
4/11/2038
Actual
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 0 0
Linear Clinical Research Ltd - Nedlands
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Cori Abikoff, 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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05878184