What side effects are associated with this type of intervention?

Common treatments for Cutaneous T-Cell Lymphoma (CTCL) include topical therapies, phototherapy, systemic therapies, and biologic agents. Topical therapies like corticosteroids can cause skin thinning and irritation. Phototherapy may lead to skin burns and an increased risk of skin cancer. Systemic therapies such as methotrexate and bexarotene can cause liver toxicity, gastrointestinal issues, and lipid abnormalities. Biologic agents like brentuximab vedotin, similar to SGN-35T, can cause peripheral neuropathy, infusion reactions, and myelosuppression. These side effects highlight the importance of monitoring and managing adverse reactions during treatment.

What prior FDA approvals exist?

Several drugs have been approved by the FDA for the treatment of Cutaneous T-Cell Lymphoma (CTCL). These include brentuximab vedotin (Adcetris), which is an antibody-drug conjugate similar to SGN-35T and is used for patients with CD30-expressing CTCL. Other treatments include romidepsin (Istodax), a histone deacetylase inhibitor, and mogamulizumab (Poteligeo), a monoclonal antibody targeting CCR4. These treatments, like SGN-35T, are often administered via infusion and have shown efficacy in managing CTCL.

What other types of research exist?

Promising novel alternatives to SGN-35T for Cutaneous T-Cell Lymphoma patients include brentuximab vedotin, which targets CD-30 and has shown efficacy in relapsed/refractory cases, and mogamulizumab, an anti-CCR4 monoclonal antibody approved for CTCL. Both have demonstrated significant clinical benefits in trials and are viable options for treatment in 2024.

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Monoclonal Antibodies

SGN-35T for Lymphoma

Phase 1

Recruiting

Research Sponsored by Seagen Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

An Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤1.

Participants must have a detectable CD30 expression level (≥1%) in tumor tissue (except cHL and ALCL where CD30 is universally expressed).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug in adults with certain types of lymphoma that haven't responded to other treatments. The drug works by targeting a protein on cancer cells and delivering a substance that kills them. This drug has shown high selectivity against specific cancer cells and has been approved for treating lymphoma patients.

Who is the study for?

This trial is for adults with advanced lymphomas, such as Hodgkin's and various T-cell lymphomas, who have tried other treatments without success or for whom no standard treatment is appropriate. Participants must have a certain level of CD30 expression in their tumors (except for specific types where it's always present) and be physically able to undergo the treatment, with an ECOG score ≤1.

What is being tested?

SGN-35T, a new drug delivered through vein infusion, is being tested for safety and effectiveness in treating different types of lymphoma. The trial has three parts: determining the best dose and schedule (Parts A & B), then assessing its safety at that dose while checking if it works against select lymphomas (Part C).

What are the potential side effects?

Since SGN-35T is new and this is its first use in humans, part of the study aims to identify side effects which are currently unknown but will include any adverse reactions participants experience besides the intended therapeutic effect.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active and can carry on all my pre-disease activities without restriction.

Select...

My tumor shows CD30 expression.

Select...

My cancer returned or worsened after treatment, including one with brentuximab vedotin.

Select...

I have received or was not eligible for anti-PD-1 therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of participants with adverse events (AEs)

Secondary study objectives

Complete response (CR) rate as assessed by the investigator

Duration of response (DOR)

Number of participants with antidrug antibodies (ADA)

+4 more

Side effects data

From 2018 Phase 3 trial • 131 Patients • NCT01578499

47%

Peripheral sensory neuropathy

36%

Nausea

27%

Diarrhoea

27%

Fatigue

17%

Vomiting

17%

Pruritus

15%

Alopecia

15%

Decreased appetite

14%

Pyrexia

12%

Myalgia

12%

Arthralgia

11%

Asthenia

11%

Oedema peripheral

11%

Rash maculo-papular

11%

Dyspnoea

11%

Pruritus generalised

Paraesthesia

Pain in extremity

Weight decreased

Hypertension

Dysgeusia

Headache

Urticaria

Neutropenia

Hyperglycaemia

Peripheral motor neuropathy

Dizziness

Chills

Upper respiratory tract infection

Hyperuricaemia

Urinary tract infection

Muscle spasms

Anaemia

Constipation

Alanine aminotransferase increased

Skin infection

Insomnia

Cough

Cellulitis

Neuropathy peripheral

Multiple organ dysfunction syndrome

Drug eruption

Cancer pain

Diverticulitis

Sepsis

Impetigo

Sinusitis

Extravasation

General physical health deterioration

Musculoskeletal chest pain

Hypotension

Dry skin

Peripheral swelling

Hypertriglyceridaemia

Lower respiratory tract infection

Fracture

Lymphoma

Neck pain

Hepatocellular injury

Intestinal perforation

Haemolytic uraemic syndrome

Pancreatitis

Pulmonary embolism

Urinary retention

Stress

Aspartate aminotransferase increased

Staphylococcal skin infection

100%

80%

60%

40%

20%

Study treatment Arm

Brentuximab Vedotin

Methotrexate or Bexarotene

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: SGN-35TExperimental Treatment1 Intervention

SGN-35T monotherapy

0 / 4Eligibility 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

Common treatments for Cutaneous T-Cell Lymphoma (CTCL) include antibody-drug conjugates, such as brentuximab vedotin, which target specific proteins on the surface of cancer cells to deliver cytotoxic agents directly to the tumor. This targeted approach is significant for CTCL patients as it aims to reduce collateral damage to healthy cells, thereby minimizing side effects and potentially improving treatment efficacy. Such therapies offer a promising alternative to traditional chemotherapy, providing a more focused attack on cancer cells while preserving the patient's overall health.