SC262 for Non-Hodgkin's Lymphoma

(VIVID Trial)

Not currently recruiting at 2 trial locations

Overseen By Sana Biotechnology, Inc

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Sana Biotechnology

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: CNS involvement, Autoimmune disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SC262 for individuals with Non-Hodgkin's Lymphoma, a type of blood cancer. The researchers aim to determine if SC262 is safe and effective when combined with a standard chemotherapy regimen. Participants should have a diagnosis of specific types of Non-Hodgkin's Lymphoma and must have previously tried, but not responded to, one CAR T cell therapy. This trial may suit those who have relapsed or have a difficult-to-treat form of the disease. As a Phase 1 trial, this research focuses on understanding how SC262 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 information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or corticosteroids (more than 10 mg/day of prednisone or equivalent), you may not be eligible to participate.

Is there any evidence suggesting that SC262 is likely to be safe for humans?

Researchers are investigating SC262 to determine the safest and most effective dose for treating non-Hodgkin's lymphoma, particularly when the cancer recurs or resists other treatments. Early studies focus on assessing SC262's safety and patient tolerance. As this is an early-phase study, researchers continue to learn about potential side effects and treatment tolerance. Specific safety information for SC262 is not yet available, but its safety undergoes close monitoring. If SC262 proves safe and well-tolerated in this phase, it may advance to further testing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

SC262 is unique because it combines a new investigational agent with a conditioning chemotherapy regimen of fludarabine and cyclophosphamide. Unlike traditional treatments for Non-Hodgkin's Lymphoma, which often rely solely on chemotherapy or immunotherapy, SC262 introduces a novel component that may enhance the effectiveness of existing drugs. Researchers are excited about SC262 because it has the potential to target cancer cells more precisely, potentially leading to better outcomes with fewer side effects. By integrating this new agent with established chemotherapy, SC262 could represent a significant advancement in treating this type of lymphoma.

What evidence suggests that SC262 might be an effective treatment for Non-Hodgkin's Lymphoma?

Studies have shown that SC262, a type of CAR T-cell therapy, holds promise for treating non-Hodgkin's lymphoma. One study with 11 patients who had B-cell lymphoma that recurred or resisted other treatments achieved a 100% overall response rate. All patients in the study experienced tumor reduction. In this trial, participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide, followed by the investigational treatment with SC262. SC262 uses specially designed T-cells (a type of immune cell) to find and destroy cancer cells. These early results suggest that SC262 could be effective for people with this type of lymphoma. However, more research is needed to confirm its safety and long-term benefits. ^{3 4 6 7 8}

Who Is on the Research Team?

John Gerecitano, MD, PhD

Principal Investigator

Sana Biotechnology, Inc.

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with certain B-cell malignancies, including various types of non-Hodgkin's lymphoma and mantle cell lymphoma. Participants must have relapsed or refractory disease after no more than one prior therapy, a life expectancy of at least 12 weeks, and be physically capable (ECOG status 0-1).

Inclusion Criteria

Histologic diagnosis of NHL (based on World Health Organization 2016 criteria) including: LBCL, including Diffuse Large B Cell Lymphoma (DLBCL) not otherwise specified (NOS) (including DLBCL arising from indolent lymphoma), Primary Mediastinal Large B-Cell Lymphoma (PMBCL), High-Grade B-Cell Lymphoma (HGBCL), and Follicular Lymphoma (FL) Grade 3B, FL, Marginal Zone Lymphomas (MZL), Mantle Cell Lymphoma (MCL), Relapsed or refractory disease after no more than 1 prior CD19-directed CAR T cell therapy, Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, At least 1 measurable (PET-positive) lesion per Lugano classification, Life expectancy ≥12 Weeks

Exclusion Criteria

Prior CD22-directed therapy including CD22-directed CAR T cell therapy or other CD22-directed antibody or cell therapy (e.g., Natural Killer (NK) cell), History of central nervous system (CNS) involvement of lymphoma within 1 year prior to enrollment, Autologous hematopoietic stem cell transplantation (HSCT) within 3 months before treatment with Lymphodepleting (LD) chemotherapy (or allogeneic HSCT at any time), Active autoimmune disease or any other diseases requiring immunosuppressive therapy or corticosteroid therapy (defined as >10 mg/day prednisone or equivalent), History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement, within 12 months of enrollment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Participants receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide

1-2 weeks

Treatment

Participants receive the investigational treatment with SC262 following chemotherapy

24 months

Follow-up

Participants are monitored for safety, tolerability, and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• SC262

Trial Overview The study is testing SC262, a new treatment for B-cell malignancies. It's in Phase 1 to check its safety, how well it works against cancer cells, what the body does to it over time, if it causes immune reactions and to look at some early signs that might predict who benefits.

How Is the Trial Designed?

Group I: SC262 Plus Chemotherapy Regimen Experimental Treatment 1 Intervention

A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with SC262

Who Is Running the Clinical Trial?

Sana Biotechnology

Lead Sponsor

Trials

5

Recruited

12,100+

Published Research Related to This Trial

CAR T cell therapy has shown significantly better response rates in patients with relapsed non-Hodgkin lymphoma compared to traditional salvage chemotherapy, indicating its efficacy in this challenging setting.

While CAR T therapy can lead to side effects like cytokine release syndrome and neurological events, most patients recover from these effects, suggesting a manageable safety profile for this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical experience of CAR T cell therapy in lymphomas. Oluwole, OO.[2022]

The review found that 42.6% of patients treated with everolimus experienced stomatitis, a common and significant side effect of anticancer therapies.

Most cases of stomatitis were mild to moderate (grade 1 or 2), accounting for 84.02% of incidents, while severe cases (grade 3 or 4) were less common at 15.97%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stomatitis And Everolimus: A Review Of Current Literature On 8,201 Patients. Arena, C., Troiano, G., Zhurakivska, K., et al.[2022]

CAR-T cell therapy shows promising efficacy in treating relapsed/refractory B-cell lymphoma, particularly in older patients and those with specific pathological types, achieving high response and complete remission rates across 17 studies.

While the treatment is generally safe, with most side effects like cytokine-releasing syndrome (CRS) and neurotoxicity being reversible, careful monitoring of these toxicities is essential during clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of chimeric antigen receptor-T cells in the treatment of B cell lymphoma: a systematic review and meta-analysis. Zheng, XH., Zhang, XY., Dong, QQ., et al.[2023]

In a study of 280 adults receiving CD19 CAR T-cell therapy for non-Hodgkin lymphoma, only 2.9% developed invasive fungal disease (IFD) without routine antifungal prophylaxis, indicating that IFD is relatively rare in this context.

Despite high rates of early toxicities like cytokine release syndrome (85%) and neurotoxicity (55%), the findings suggest that routine antifungal prophylaxis may not be necessary in institutions with low rates of IFD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low incidence of invasive fungal disease following CD19 chimeric antigen receptor T-cell therapy for non-Hodgkin lymphoma. Little, JS., Aleissa, MM., Beluch, K., et al.[2022]

In a study of 11 patients with relapsed and refractory B-cell lymphoma, anti-CD19 CAR T-cell therapy achieved a remarkable overall response rate of 100%, with a complete remission rate of 63.6% after 3 months, indicating its high efficacy as a treatment option.

The therapy was generally safe, with a 36.4% incidence of Grade 2 cytokine release syndrome and one case of Grade 3 CAR T-cell-related encephalopathy syndrome, suggesting manageable adverse reactions in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of CD19 chimeric antigen receptor T cells in the treatment of 11 patients with relapsed/refractory B-cell lymphoma: a single-center study. Huang, C., Wu, L., Liu, R., et al.[2022]

Citations

1. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/SANA/pressreleases/35743581/sana-biotechnology-advances-car-t-therapy-with-sc262-in-non-hodgkins-lymphoma-study/

Sana Biotechnology Advances CAR-T Therapy with SC262 ... The study aims to assess the safety, tolerability, anti-tumor activity, cellular kinetics, and immunogenicity of SC262 in patients with relapsed ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06285422

Study Evaluating SC262 in Subjects With r/r Non-Hodgkin's ... This is an open-label, single arm, Phase 1, first-in-human (FIH) study to evaluate the safety and tolerability of SC262 administered intravenously (IV) ...

3. trial.medpath.com trial.medpath.com/clinical-trial/375cacbf20f5405f/nct06285422-sc262-hypoimmune-car-t-cell-therapy-non-hodgkins-lymphoma

Study Evaluating SC262 in Subjects With r/r Non-Hodgkin's ... This is an open-label, single arm, Phase 1, first-in-human (FIH) study to evaluate the safety and tolerability of SC262 administered intravenously (IV) ...

4. withpower.com withpower.com/trial/phase-1-non-hodgkins-lymphoma-nhl-3-2024-e7ac3

SC262 for Non-Hodgkin's Lymphoma (VIVID Trial) In a study of 11 patients with relapsed and refractory B-cell lymphoma, anti-CD19 CAR T-cell therapy achieved a remarkable overall response rate of 100%, with a ...

5. fredhutch.org fredhutch.org/en/research/clinical-trials/trial-details.fh_trial_id_15144.study-evaluating-sc262-in-subjects-with-r-r-non-hodgkin-s-lymphoma-vivid.html

Study Evaluating SC262 in Subjects with R/?r Non- ... A Phase 1 study evaluating SC262, a hypoimmune, allogeneic CD22-directed CAR T cell therapy, in relapsed and/or refractory non-Hodgkin's lymphoma (VIVID)

6. dukecancerinstitute.org dukecancerinstitute.org/clinical-trials/phase-1-study-sc262-allo-car-t-rr-non-hodgkins-lymphoma

Phase 1 study of SC262 allo CAR-T in R/R non-Hodgkin's ... We are doing this study to find the most effective, safe dose of an experimental drug called SC262 (the study drug) in people with relapsed and/or refractory ...

7. ctsearchsupport.org ctsearchsupport.org/clinical-trials/study-evaluating-sc262-in-subjects-with-r-r-b-cell-malignancies-vivid

CAR T cells (SC262) to treat B-cell non-Hodgkin lymphoma ... To find out:The highest dose of SC262 that's safe to giveIf SC262 is safe and works well to treat B-NHL that has relapsed or is refractory.

8. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/465115

Study Evaluating SC262 in Subjects With r/r Non-Hodgkin's ... SC262-101 is a Phase 1 study to evaluate SC262 safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory ...