SB-4826 for Non-Hodgkin's Lymphoma

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of California, San Diego

Must not be taking: Chemotherapy, Immunotherapy, Biologics, others

Disqualifiers: Cardiovascular disease, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safest dose of a new drug, SB-4826, for treating solid tumors and non-Hodgkin's lymphoma, a type of cancer affecting the lymphatic system. Researchers seek to understand how the body processes the drug and its effectiveness against cancer. The trial tests SB-4826 alone in some cases and with another drug, rituximab, in others. It suits individuals with non-Hodgkin's lymphoma or advanced solid tumors who have experienced symptoms like fevers, weight loss, or night sweats after other treatments. Participants will take SB-4826 every other day and undergo regular checkups. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it does exclude those using certain cancer therapies, cellular therapies, or specific medications affecting liver enzymes within a certain timeframe before starting the trial. It's best to discuss your current medications with the trial team to see if they might affect your eligibility.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies are testing SB-4826 to find the safest dose for patients with solid tumors and non-Hodgkin lymphomas. The main goal is to determine the maximum amount of the drug that can be administered without causing serious side effects. Earlier research found that doses of 60 mg or more were generally safe, leading to a recommended dose of 90 mg taken twice a week.

When combined with rituximab for non-Hodgkin lymphoma patients, safety remains a priority. Rituximab has been used for a long time, with known side effects such as fever, chills, and nausea, mostly occurring during the first infusion (administered intravenously).

Overall, the studies are still in early stages, so safety data is limited. However, SB-4826, both alone and with rituximab, undergoes careful monitoring to ensure it is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatment options for Non-Hodgkin's Lymphoma, such as chemotherapy and monoclonal antibodies like rituximab, SB-4826 introduces a novel approach. Researchers are excited about SB-4826 because it potentially targets cancer cells differently, offering a new mechanism of action. In particular, SB-4826 is being tested both as a monotherapy and in combination with rituximab, potentially enhancing the effectiveness of existing treatments. These trials aim to determine if SB-4826 can improve outcomes by being more effective in killing cancer cells or reducing side effects compared to current therapies.

What evidence suggests that SB-4826 might be an effective treatment for non-Hodgkin's lymphoma?

Research has shown that SB-4826 could be a promising treatment for non-Hodgkin's lymphoma. Early results suggest that SB-4826 blocks a process that helps cancer cells survive, which could be a major breakthrough for patients with limited treatment options. In this trial, some participants will receive SB-4826 as monotherapy, while others will receive it in combination with rituximab. When combined with rituximab, a drug already proven to treat non-Hodgkin's lymphoma, the combination has demonstrated high success rates. Rituximab alone has been effective, especially for patients whose cancer has returned or is difficult to treat. Overall, early evidence supports the potential of SB-4826, particularly when combined with rituximab. ^{1 6 7 8 9}

Who Is on the Research Team?

Peter Vu, MD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for adults with advanced or widespread solid tumors or non-Hodgkin lymphomas. Participants must be able to take medication every other day and commit to regular clinic visits, tests, and maintaining a drug diary at home.

Inclusion Criteria

I can sign and understand the consent form.

I am 18 years old or older.

Life expectancy ≥ 3 months

Exclusion Criteria

Mean resting corrected QT interval using Fridericia's formula > 470 msec

Receipt of investigational products within specified timeframe

I have not taken certain medications recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Dose-Escalation

Participants receive SB-4826 monotherapy or in combination with rituximab to determine the recommended phase 2 dose

21 days

Weekly visits for dose escalation monitoring

Phase 2 Dose-Expansion/Combination Therapy

Participants with non-Hodgkin lymphomas receive SB-4826 at the recommended phase 2 dose in combination with rituximab

Up to 1 year

Weekly visits for the first cycle, then every 9 weeks for maintenance

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• SB-4826

Trial Overview The study is testing the safety of different doses of SB-4826 on its own in solid tumor cases, and alongside Rituximab for non-Hodgkin lymphomas. It aims to find the highest safe dose, understand how it works against cancer, and track how it's processed by the body.

How Is the Trial Designed?

Group I: Non-Hodgkin lymphoma Phase 2 combination therapy Experimental Treatment 2 Interventions

Phase 2 dose expansion SB-4826 in combination with rituximab

Group II: Non-Hodgkin lymphoma Phase 1 monotherapy Experimental Treatment 1 Intervention

Phase 1 dose escalation SB-4826 monotherapy

Group III: Non-Hodgkin lymphoma Phase 1 combination therapy Experimental Treatment 2 Interventions

Phase 1 dose escalation SB-4826 in combination with rituximab

Group IV: Locally advanced or metastatic solid tumors Phase 1 monotherapy Experimental Treatment 1 Intervention

Phase 1 dose escalation SB-4826 monotherapy

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

The Institute for Follicular Lymphoma Innovation

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07222631

SB-4826 in Adult Participants With Locally Advanced or ... The goal of this clinical trial is to learn what dose of the drug SB-4826 can be given safely in patients with solid tumors and non-Hodgkin ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2844047/

Impact of Rituximab (Rituxan) on the Treatment of B-Cell Non ... This combination was found to be very effective, with an ORR of 92%. Maintenance Therapy for Follicular Lymphoma. Some authors consider rituximab to be an ideal ...

3. rituxan-hcp.com rituxan-hcp.com/nhl/efficacy/clinical-trial-results/relapsed-refractory.html

RITUXAN® (rituximab) Single-Arm Clinical Trial Results For ... RITUXAN monotherapy delivered durable responses in relapsed or refractory, low-grade or follicular NHL in 3 single-arm trials.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00147953

NCT00147953 | Study to Evaluate the Efficacy of Rituximab ... This study aims to assess the short term efficacy of a combination of rituximab and low-dose radiotherapy in patients with non-Hodgkin's lymphoma. Detailed ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2727901/

Rituximab in the treatment of non-Hodgkin's lymphoma - PMC In a first-line trial, treatment with the monoclonal antibody for 4 cycles every 6 months for up to 2 years gave a 58% rate (9% CR) (Hainsworth et al 2003).

6. withpower.com withpower.com/trial/phase-2-lymphoma-non-hodgkin-1-2026-67b0c

SB-4826 for Non-Hodgkin's Lymphoma · Info for Participants Trial Overview The study is testing the safety of different doses of SB-4826 on its own in solid tumor cases, and alongside Rituximab for non-Hodgkin lymphomas.

7. smartpatients.com smartpatients.com/trials/NCT07222631

SB-4826 in Adult Participants With Locally Advanced or ... The goal of this clinical trial is to learn what dose of the drug SB-4826 can be given safely in patients with solid tumors and non-Hodgkin ...

8. rituxan-hcp.com rituxan-hcp.com/nhl.html

Non-Hodgkins Lymphoma (NHL) | RITUXAN® (rituximab) Warnings and Precautions · Mucocutaneous reactions, some with fatal outcome, can occur in patients treated with RITUXAN. · The onset of these reactions has been ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2833973/

B cell non-Hodgkin's lymphoma: rituximab safety experience The most common grade 1 or 2 toxicities were fever (18%), chills/rigors (26%), and nausea (21%). Almost all AEs occurred during the first rituximab infusion.