F01 in the Treatment of Relapsed/Refractory Non-hodgkin's Lymphoma

NCT06206902 | Unknown Phase 1

• 1 other identifier: SNC 103-CD19CAR NK-101
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

Brief Summary

This is a multicenter, open, Phase I clinical study to evaluate the safety and tolerability of F01 in subjects with relapsed/refractory non-Hodgkin lymphoma, and to determine MTD and/or RD.

Conditions

Non-Hodgkin's Lymphoma

Keywords

NK; Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (2)

• Safety of F01 cells

  The incidence, nature and severity of all adverse events, serious adverse events, and abnormal laboratory test results

  Up to 24 months

• Safety of F01 cells

  Incidence of DLT

  Up to 1 month

Secondary Outcomes (14)

• Response rate (ORR) of F01 cells

  From 1 to 24 months after infusion

• Duration of response (DOR) of F01 cells

  From 1 to 24 months after infusion

• Progression-free survival (PFS) of F01 cells

  From 1 to 24 months after infusion

• Overall survival (OS) of F01 cells

  From 1 to 24 months after infusion

• Maximum concentration of F01 cells

  From 1 to 15 years after infusion or after learning of undetectable results

Other Outcomes (2)

• The correlation among PK, PD, efficacy, and safety

  From 1 to 24 months

• The correlation among KIR mismatch , efficacy and safety

  From 1 to 24 months

Study Arms (1)

Assigned Interventions

EXPERIMENTAL

Drug: After preconditioning with chemotherapy, F01 will be evaluated.

Interventions

After preconditioning with chemotherapy, F01 will be evaluated. DRUG

Biological: 0.5-3×10\^9 CAR+NK Cells, Treatment follows a lymphodepletion Drug: Fludarabine: 30 mg/m\^2 (D-5\~D-3) Drug: Cyclophosphamide: 300 mg/ m\^2 (D-5\~D-3)

Assigned Interventions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old, gender unlimited.
• ECOG score 0-2 points.
• Large B-cell lymphoma or follicular lymphoma grade 3b was confirmed by histopathology.Large B-cell lymphomas include the following types as defined by WHO2016:
• Diffuse large B lymphoma (DLBCL), non-specific type (NOS);
• Large B-cell lymphoma rich in T cells/histiocytic cells;
• EBV positive DLBCL, non-specific type (NOS);
• Primary mediastinal (thymus) large B-cell lymphoma;
• High-grade B-cell lymphoma, non-specific type (NOS) and high-grade B-cell lymphoma with MYC and BCL2 or BCL6 rearrangement;
• Follicular lymphoma or other inert lymphoma transformed DLBCL.
• Must have been previously treated with at least 2-line systemic anti-B-cell lymphoma. Participants must have received at least one course of anthracycline-based chemotherapy (except when absolutely contraindicated due to cardiac dysfunction) and at least one course of anti-CD20 immunotherapy (except in CD20-negative subjects or contraindicated due to severe toxicity).
• Induction + consolidation + transplantation + maintenance treatment is a one-line system of treatment;
• Anti-CD20 monotherapy does not count as 1-line systemic therapy;
• Local radiotherapy does not count as 1-line systemic therapy.
• Patients who have previously received targeted CD19 therapy (including monoclonal antibody, double antibody, CAR-T, experimental therapy, etc.) should provide histophistological reports during screening stage to confirm that CD19 expression is still present in lymphoma tissues after the last targeted CD19 therapy.
• Imaging evidence indicates recurrent or refractory disease.

You may not qualify if:

• Subjects with known allergic reactions, hypersensitivities, intolerances, or contraindications to F01 or any component of the drugs that may be used in the study, including fludarabine, cyclophosphamide, and tocilizumab, or who have previously experienced severe allergic reactions.
• Primary central nervous system lymphoma.
• Subjects with gastrointestinal lymphoma who had a history of ≥ grade 3 gastrointestinal bleeding in the 3 months prior to screening and those at risk of developing ≥ grade 3 gastrointestinal bleeding as assessed by investigators (CTCAE, version 5.0).
• Subjects with a history of central nervous system lymphoma, lymphoma cells found in cerebrospinal fluid, and previous imaging findings of intracranial involvement of lymphoma could not be enrolled.
• Performed allogeneic hematopoietic stem cell transplantation.
• Autologous hematopoietic stem cell transplantation was performed within 3 months before eluvial pre-treatment chemotherapy.
• Subjects who have previously received CD19-targeted CAR-NK therapy; The best efficacy of previous targeted CD19 CAR-T therapy \< PR.
• Major surgery or live vaccination within 28 days prior to screening.
• Received the following anti-tumor therapy within the specified time frame before eluvial pre-treatment chemotherapy:
• Received small molecule targeted therapy within 3 weeks or 5 half-lives (whichever is longer);
• Receiving large molecule drug therapy within 4 weeks or 5 half-lives, whichever is longer (4 weeks for anti-CD20 antibody);
• Received cytotoxic therapy or modern Chinese medicine with anti-tumor effects within 3 weeks (liposomal adriamycin washout period was 4 weeks);
• Have received experimental therapy within 4 weeks (except for explicit placebo control);
• Received local palliative radiotherapy within 2 weeks.
• Previous CNS disease, such as seizures, cerebrovascular accidents (ischemia/bleeding), dementia, cerebellar disease, or any CNS related autoimmune disease.

Sponsors & Collaborators

• Shanghai Simnova Biotechnology Co.,Ltd.: lead
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator

Study Sites (2)

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Director Clinical Trial Disclosure Simnova

CONTACT

021-68099999; Disclosure@simnovabio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 16, 2024
• Study Start: April 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 23, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)