SC262 for Non-Hodgkin's Lymphoma

(VIVID Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Sana Biotechnology

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: CNS involvement, Autoimmune disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

SC262-101 is a Phase 1 study to evaluate SC262 safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.

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.

What safety data exists for SC262 (CAR T-cell therapy) in humans?

CAR T-cell therapy, which includes SC262, has been tested in people with lymphoma and has shown some side effects like cytokine release syndrome (CRS), neurological events, and infections. Most patients recover from these side effects, and serious infections are rare. ^{1 2 3 4 5}

Research Team

Cori Abikoff, MD

Principal Investigator

Sana Biotechnology, Inc.

Eligibility Criteria

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

I am between 18 and 80 years old.

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.

Trial Timeline

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

Treatment Details

Interventions

• SC262 (CAR T-cell Therapy)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Low incidence of invasive fungal disease following CD19 chimeric antigen receptor T-cell therapy for non-Hodgkin lymphoma. [2022]

3. China 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. [2022]

4. China 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. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Stomatitis And Everolimus: A Review Of Current Literature On 8,201 Patients. [2022]