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SC291 for B-Cell Malignancies

Phase 1
Recruiting
Research Sponsored by Sana Biotechnology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
CLL or SLL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial will test a new drug to see if it's safe and if it kills cancer cells.

Who is the study for?
This trial is for adults aged 18-75 with certain B-cell malignancies, including various types of non-Hodgkin's lymphoma and chronic leukemias. Participants must have relapsed or refractory disease after at least two prior treatments or a stem cell transplant, be relatively fit (ECOG status 0 or 1), and have a life expectancy of at least 12 weeks.Check my eligibility
What is being tested?
The study is testing SC291, an investigational drug for B-cell malignancies. It's in Phase 1 to assess safety, how well it works against cancer, its effects on the body over time, potential immune reactions to it, and any biomarkers that might predict who benefits from it.See study design
What are the potential side effects?
As this is an early-phase trial for SC291, specific side effects are not yet fully known but may include typical symptoms associated with cancer therapies such as fatigue, nausea, allergic reactions and potentially impacts on blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a type of large B-cell lymphoma.
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I have been diagnosed with CLL or SLL.
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I have follicular lymphoma, but not grade 3B.
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I am fully active or can carry out light work.
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I have a tumor that can be measured or I meet the treatment criteria for CLL.
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My condition worsened after 2 treatments or a stem cell transplant.
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I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate safety and tolerability of SC291
Secondary outcome measures
Evaluate cellular kinetics and persistence of SC291
Evaluate host immunogenicity to SC291
Evaluate preliminary anti-tumor activity of SC291

Trial Design

1Treatment groups
Experimental Treatment
Group I: SC291 Plus Chemotherapy RegimenExperimental Treatment1 Intervention
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with SC291

Find a Location

Who is running the clinical trial?

Sana BiotechnologyLead Sponsor
3 Previous Clinical Trials
73 Total Patients Enrolled
Paul Brunetta, MDStudy DirectorSana Biotechnology, Inc.
2 Previous Clinical Trials
179 Total Patients Enrolled
Hosein Kouros-Mehr, MDStudy DirectorSana Biotechnology

Media Library

SC291 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05878184 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: SC291 Plus Chemotherapy Regimen
Non-Hodgkin's Lymphoma Clinical Trial 2023: SC291 Highlights & Side Effects. Trial Name: NCT05878184 — Phase 1
SC291 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05878184 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What health risks does the SC291 Plus Chemotherapy Regimen entail for patients?

"As this is an early phase trial, with limited evidence to support its safety and efficacy, SC291 Plus Chemotherapy Regimen was assessed as a 1 on the scale."

Answered by AI

What criteria must be met in order for a participant to qualify for this research project?

"To meet the criteria for this clinical study, participants must be diagnosed with either lymphoma or leukemia and between 18 to 75 years of age. A total of 54 patients will ultimately join the trial."

Answered by AI

How many volunteers have joined this clinical exploration?

"Affirmative. Per the clinicaltrials.gov page, this research is actively enrolling individuals as of May 17th, 2023. It was first posted on 2nd May 2021 and requires 54 recruits from two distinct sites."

Answered by AI

Is this study open to individuals who are younger than 45 years old?

"This clinical trial has a set of eligibility requirements that stipulate participants must be aged between 18-75. For the population younger than 18, there are 482 studies available and 1860 for those above 65 years old."

Answered by AI

Are there open positions available to participate in this experimental research?

"As indicated by the clinicaltrials.gov website, this trial is presently seeking participants for participation; it was initially published on May 2nd 2023 and last modified on May 17th 2023."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study Evaluating SC291 in Subjects With r/r B-cell Malignancies (ARDENT)
2023. "Study Evaluating SC291 in Subjects With r/r B-cell Malignancies (ARDENT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05878184.
~38 spots leftby Dec 2026
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