What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma (NHL), including chemotherapy, immunotherapy, and targeted therapies, often have overlapping side effects. Chemotherapy can cause nausea, vomiting, fatigue, hair loss, and increased infection risk due to bone marrow suppression. Immunotherapy, such as monoclonal antibodies, may lead to infusion reactions, skin rashes, and immune-related adverse events like colitis or pneumonitis. Targeted therapies can cause specific organ toxicities, such as liver or kidney damage, and other side effects like hypertension and diarrhea. The investigational drug CC-96673 will likely be evaluated for similar side effects to ensure its safety profile is acceptable for patients with relapsed or refractory NHL.

What prior FDA approvals exist?

Several drugs have been approved by the FDA for the treatment of Non-Hodgkin's Lymphoma, particularly for relapsed or refractory cases. These include monoclonal antibodies like Rituximab, which targets the CD20 antigen on B-cells, and CAR-T cell therapies such as Axicabtagene Ciloleucel and Tisagenlecleucel, which are engineered to target CD19 on B-cells. Additionally, small molecule inhibitors like Ibrutinib, which inhibits Bruton's tyrosine kinase, have also been approved. These treatments share a focus on targeting specific antigens or pathways involved in the proliferation of lymphoma cells, similar to the investigational drug CC-96673.

What other types of research exist?

Promising novel alternatives to CC-96673 for Non-Hodgkin's Lymphoma patients include: 1) CAR-T cell therapies such as Brexucabtagene autoleucel, which has shown high overall response rates and durable remissions in relapsed or refractory NHL. 2) Monoclonal antibodies like Blinatumomab and Inotuzumab ozogamicin, which target specific antigens on lymphoma cells and have demonstrated efficacy in clinical trials. 3) Immune checkpoint inhibitors, such as Pembrolizumab, which have been effective in various cancers and are being explored for NHL. These alternatives offer new hope for patients with relapsed or refractory NHL.

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CC-96673 for Lymphoma

Phase 1

Waitlist Available

Research Sponsored by Celgene

Eligibility Criteria Checklist

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

Must have

Participant (male or female) is ≥ 18 years of age at the time of signing the informed consent form (ICF).

Participant must have a history of NHL that has relapsed or progressed.

Must not have

History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.

Participant has received prior investigational therapy directed at CD47 or SIRPα.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years after study treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called CC-96673 to see if it is safe for adults whose Non-Hodgkin's Lymphoma has come back or did not respond to previous treatments. The drug aims to attack and kill the cancer cells.

Who is the study for?

Adults over 18 with Non-Hodgkin's Lymphoma that has come back or didn't respond to treatment can join. They must be able to follow the study plan, have a performance status showing they're mostly active and well, and meet certain lab value criteria. People with brain-involved cancer symptoms, other active cancers, significant heart issues, recent major surgery, pregnancy, HIV/HBV/HCV infections or on certain immune-suppressing drugs cannot participate.

What is being tested?

The trial is testing CC-96673 for safety and how well it's tolerated in adults with relapsed/refractory Non-Hodgkin's Lymphoma. It includes two parts: first finding the right dose (Part A) and then seeing how it works at that dose (Part B).

What are the potential side effects?

While specific side effects of CC-96673 are not listed here as this is an early-phase trial aimed at determining safety and tolerability, common side effects from similar treatments may include fatigue, allergic reactions, blood count changes leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years or older and have signed the consent form.

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My non-Hodgkin lymphoma has come back or gotten worse.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of autoimmune blood disorders.

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I have previously been treated with drugs targeting CD47 or SIRPα.

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I have an active HIV infection.

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I have an active hepatitis B or C infection.

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I am currently on a regular dose of blood thinners.

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My cancer has spread to my brain and is causing symptoms.

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I am currently receiving treatment for another cancer besides the one being studied.

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My heart does not function properly, or I have serious heart disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years after study treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years after study treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years after study treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Dose-limiting toxicity (DLT)

Incidence of Adverse Events (AEs)

Maximum tolerated dose (MTD)

Secondary study objectives

Duration of response (DOR)

Overall response rate (ORR)

Pharmacokinetics - AUC

+4 more

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: Administration of CC-96673Experimental Treatment1 Intervention

CC-96673 will be administered on a once weekly (Q1W) or once every 2 weeks (Q2W) schedule

0 / 11Eligibility 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 chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect normal cells, leading to side effects. Targeted therapies, such as monoclonal antibodies, specifically target cancer cell markers, minimizing damage to normal cells. Immunotherapy, including CAR-T cell therapy, harnesses the patient's immune system to recognize and destroy cancer cells. Understanding these mechanisms is crucial for NHL patients as it helps them comprehend how treatments work, potential side effects, and the rationale behind new therapies like CC-96673, which aims to improve safety and tolerability while effectively targeting cancer cells.