What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma, particularly those involving cellular or immunotherapy such as monoclonal antibodies (e.g., rituximab), CAR T-cell therapy, and immune checkpoint inhibitors, can have several side effects. Monoclonal antibodies may cause infusion reactions, fever, chills, and infections. CAR T-cell therapy is associated with cytokine release syndrome (CRS), which can cause fever, low blood pressure, and difficulty breathing, as well as neurotoxicity, leading to confusion or seizures. Immune checkpoint inhibitors can lead to immune-related adverse events, including colitis, hepatitis, pneumonitis, and endocrinopathies. These side effects vary in severity and require careful monitoring and management.

What prior FDA approvals exist?

Several FDA-approved treatments for Non-Hodgkin's Lymphoma (NHL) involve cellular and immunotherapy approaches. Notable examples include CAR-T cell therapies such as axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah), which are designed to target and destroy cancerous B cells. Additionally, monoclonal antibodies like rituximab (Rituxan) and obinutuzumab (Gazyva) have been approved for targeting CD20 on B cells. These therapies represent significant advancements in the treatment of NHL by harnessing the body's immune system to fight cancer.

What other types of research exist?

Promising novel alternatives to SC291 for Non-Hodgkin's Lymphoma patients include: 1) CMC-544, a CD22-targeted immunoconjugate of calicheamicin, which has shown strong antitumor activity in preclinical studies. 2) BL22, a fusion toxin targeting the CD22 antigen, demonstrating marked activity in treating hairy cell leukemia, which is a subtype of NHL. 3) MDX-1401, a nonfucosylated fully human monoclonal antibody targeting CD30, showing greater in vitro and in vivo activity compared to its parental antibody. These therapies represent advanced options that could be considered in 2024.

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SC291 for B-Cell Malignancies

Phase 1

Waitlist Available

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

No Placebo-Only Group

Summary

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.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluate safety and tolerability of SC291

Secondary study objectives

Evaluate cellular kinetics and persistence of SC291

Evaluate host immunogenicity to SC291

Evaluate preliminary anti-tumor activity of SC291

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Hodgkin's Lymphoma (NHL) include cellular and immunotherapies, such as CAR-T cell therapy and monoclonal antibodies. CAR-T cell therapy involves modifying a patient's T cells to express a receptor specific to cancer cells, enabling the immune system to target and destroy these cells. Monoclonal antibodies, like rituximab, bind to specific proteins on the surface of lymphoma cells, marking them for destruction by the immune system. These therapies are crucial for NHL patients as they offer targeted treatment options that can lead to more effective and personalized care, potentially improving outcomes and reducing side effects compared to traditional chemotherapy.