16 Participants Needed

SC291 for B-Cell Malignancies

Recruiting at 9 trial locations
NO
BM
Overseen ByBarbara Metallo
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial tests SC291, a new drug for blood cancers, in patients with NHL or CLL who have tried multiple treatments. SC291 is given after chemotherapy to better target cancer cells.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have had systemic anticancer therapy or radiotherapy within 14 days of starting the trial (28 days for biologics).

What data supports the effectiveness of the treatment SC291 for B-Cell Malignancies?

Research shows that targeting CD19, a marker found on B cells, is promising for treating B cell disorders, including blood cancers. This suggests that treatments like SC291, which may target CD19, could be effective for B-Cell Malignancies.12345

Is SC291 safe for humans?

SC291, which may be related to PD-1/PD-L1 inhibitors, has been studied for safety in cancer patients. These treatments can cause immune-related side effects like skin rashes and thyroid issues, but they are generally manageable and rarely lead to stopping treatment.678910

How does the drug SC291 work differently for B-cell malignancies?

SC291 is unique because it targets the B29 gene, which is often mutated in B-cell malignancies like chronic lymphocytic leukemia (CLL). These mutations affect the B cell receptor's ability to signal properly, and SC291 aims to correct these mutations, potentially improving the effectiveness of existing treatments.1112131415

Research Team

CA

Cori Abikoff, MD

Principal Investigator

Sana Biotechnology, Inc.

Eligibility Criteria

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.

Inclusion Criteria

I have a type of large B-cell lymphoma.
I have been diagnosed with marginal zone lymphoma.
I have been diagnosed with CLL or SLL.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lymphodepleting Chemotherapy

Participants receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide

1 week

Treatment

Participants receive the investigational treatment SC291 following chemotherapy

24 months

Follow-up

Participants are monitored for safety, tolerability, and anti-tumor activity

24 months

Treatment Details

Interventions

  • SC291
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

Sana Biotechnology

Lead Sponsor

Trials
5
Recruited
12,100+

Findings from Research

Adjuvant therapy with PD-1/PD-L1 inhibitors significantly improves overall survival (OS) and disease-free survival (DFS) in cancer patients, based on a meta-analysis of six randomized controlled trials involving 4,436 participants.
While these treatments offer substantial survival benefits, they are also associated with a higher risk of severe treatment-related adverse events (≥ grade 3), indicating a need for careful monitoring during therapy.
Efficacy and safety of adjuvant therapy with PD‑1/PD‑L1 inhibitors in cancer.Mo, DC., Liang, ZY., Chen, L., et al.[2022]
In a meta-analysis of 11,465 patients from 18 clinical trials, PD-1/PD-L1 inhibitors were found to significantly increase the risk of developing dermatologic adverse effects like rash and pruritus compared to chemotherapy, with relative risks of 1.84 and 3.74, respectively.
PD-1/PD-L1 inhibitors showed a lower risk of mucosal inflammation and alopecia compared to chemotherapy, indicating a distinct safety profile that differs from traditional cancer treatments.
Risk of dermatologic and mucosal adverse events associated with PD-1/PD-L1 inhibitors in cancer patients: A meta-analysis of randomized controlled trials.Yang, W., Li, S., Yang, Q.[2021]
A meta-analysis of 21 studies involving 11,144 patients revealed that anti-CTLA4 therapy significantly increases the risk of various immune-related adverse events, such as diarrhea and colitis, with a relative risk of 2.43 to 11.39 for different conditions.
In contrast, while anti-PD1 therapy also raises the risk of pruritus (itching) with a relative risk of 4.01, it does not appear to increase the risk of other immune-related adverse events, highlighting the distinct safety profiles of these therapies.
Meta-Analysis of the Risk of Immune-Related Adverse Events With Anticytotoxic T-Lymphocyte-Associated Antigen 4 and Antiprogrammed Death 1 Therapies.Komaki, Y., Komaki, F., Yamada, A., et al.[2022]

References

CD19-targeted immunotherapies for treatment of patients with non-Hodgkin B-cell lymphomas. [2019]
Outcomes of patients with relapsed/refractory diffuse large B-cell lymphoma with progression of lymphoma after autologous stem cell transplantation in the rituximab era. [2015]
Assessment of Salvage Regimens Post-Chimeric Antigen Receptor T Cell Therapy for Patients with Diffuse Large B Cell Lymphoma. [2022]
CD19 as an attractive target for antibody-based therapy. [2021]
Treatment strategy in chronic lymphocytic leukemia with symptomatic central nervous system involvement: A case report. [2023]
Efficacy and safety of adjuvant therapy with PD‑1/PD‑L1 inhibitors in cancer. [2022]
Risk of dermatologic and mucosal adverse events associated with PD-1/PD-L1 inhibitors in cancer patients: A meta-analysis of randomized controlled trials. [2021]
Meta-Analysis of the Risk of Immune-Related Adverse Events With Anticytotoxic T-Lymphocyte-Associated Antigen 4 and Antiprogrammed Death 1 Therapies. [2022]
Safety of Programmed Death-1 Pathway Inhibitors Among Patients With Non-Small-Cell Lung Cancer and Preexisting Autoimmune Disorders. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Thyroid Immune-Related Adverse Events in Patients with Cancer Treated with anti-PD1/anti-CTLA4 Immune Checkpoint Inhibitor Combination: Clinical Course and Outcomes. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Widespread B29 (CD79b) gene defects and loss of expression in chronic lymphocytic leukemia. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
B29 gene products complex with immunoglobulins on B lymphocytes. [2019]
13.United Statespubmed.ncbi.nlm.nih.gov
Aberrant B cell receptor signaling from B29 (Igbeta, CD79b) gene mutations of chronic lymphocytic leukemia B cells. [2018]
Expression of the immunoglobulin-associated protein B29 in B cell disorders with the monoclonal antibody SN8 (CD79b). [2017]
15.United Statespubmed.ncbi.nlm.nih.gov
Isolation and chromosomal mapping of the human immunoglobulin-associated B29 gene (IGB). [2007]