Safety and Efficacy of Anti-CD20/CD30 CAR-T Cells in Subjects with Relapsed/Refractory Lymphoma

NCT06532643 | Recruiting Early Phase 1

• 1 other identifier: CD20/CD30-CN-A1
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an exploratory clinical trial of a single-center, open-label, single-dose treatment of anti-CD20/CD30-CAR-T cells in subjects with relapsed/refractory lymphoma.

Conditions

Relapsed/Refractory Lymphoma

Outcome Measures

Primary Outcomes (2)

• Safety and tolerance

  Incidence of dose-limiting toxicity (DLT)

  28 days after infusion of anti-CD20/CD30-CAR-T cells

• Manufacturing feasibility

  Percentage of subjects for whom the required dose of anti-CD20/CD30-CAR-T cells can be successfully manufactured.

  1 year

Study Arms (1)

Anti-CD20/CD30-CAR-T Cell Therapy

EXPERIMENTAL

Investigational product: anti-CD20/CD30-CAR-T cells Route of administration: Intravenous injection Lymphodepleting chemotherapy regimen: A combination of fludarabine and cyclophosphamide will be administered prior to the infusion of anti-CD20/CD30-CAR-T cells.

Genetic: anti-CD20/CD30-CAR-T cells; Drug: Fludarabine; Drug: Cyclophosphamide

Interventions

anti-CD20/CD30-CAR-T cells GENETIC

Each subject will be infused with single dose of anti-CD20/CD30-CAR-T cells. A classic "3+3" dose escalation will be employed.

Anti-CD20/CD30-CAR-T Cell Therapy

Fludarabine DRUG

Fludarabine will be given at a dose of 25 mg/m2/day intravenously (IV) for 3 days prior to the infusion of anti-CD20/CD30-CAR-T cells.

Anti-CD20/CD30-CAR-T Cell Therapy

Cyclophosphamide DRUG

Cyclophosphamide will be given at a dose of 250 mg/m2/day intravenously (IV) for 3 days prior to the infusion of anti-CD20/CD30-CAR-T cells.

Anti-CD20/CD30-CAR-T Cell Therapy

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must meet all of the following criteria to be eligible for the study:
• Voluntarily participate in the clinical study. The individual or the legal guardian fully understands the study, sign the informed consent form (ICF), and is willing and able to follow and complete all trial procedures.
• Age ≥ 14 years and \< 70 years.
• Subjects with refractory or relapsed disease after current standard treatments (including allogeneic or autologous hematopoietic stem cell transplantation) who are not suitable for other treatment options, such as a second stem cell transplant. The definitions of relapsed/refractory lymphoma include one of the following situations:
• No response to first-line treatment (primary refractory disease, excluding participants intolerant to first-line treatments).
• Disease progression (PD) as assessed after first-line treatment.
• Best efficacy of first-line treatment (e.g., 4 cycles of RCHOP) as stable disease (SD), with the duration of SD not exceeding 6 months after the last dose.
• No response to second-line or more treatments.
• PD being the best response to the most recent treatment.
• Best efficacy of the last line of treatment as SD after at least 2 cycles, with the duration of SD not exceeding 6 months after the last dose.
• Refractory after autologous stem cell transplant (ASCT).
• Disease progression or relapse ≤ 12 months post-ASCT (relapsed patients must have biopsy-proven relapse).
• If salvage treatment is administered after ASCT, the subjects must not have had a response or relapse after the last line of treatment.
• Relapsed or refractory disease after two or more lines of systemic treatment.
• Lymphoma patients must have target antigens meeting the following criteria:

You may not qualify if:

• Subjects are not eligible to participate in this study if they meet any of the following criteria:
• MRI of the brain shows evidence of central nervous system lymphoma; active primary central nervous system DLBL, unless central nervous system involvement has been effectively treated (i.e., participant is asymptomatic), and there has been more than a 4-week gap since local treatment.
• Active central nervous system diseases, such as epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases, or any autoimmune diseases with central nervous system involvement.
• History of or concurrent diagnosis of malignancies other than CD19+ malignancies.
• Clinically significant heart disease or arrhythmias that cannot be controlled with medication.
• Presence or suspicion of fungal, bacterial, viral, or other infections that are uncontrolled or require intravenous antibiotics for treatment; uncomplicated urinary tract infections and uncomplicated bacterial pharyngitis are allowed.
• Positive for hepatitis B (HBsAg positive and HBV DNA \>1000 copies/mL) and hepatitis C (positive for HCV antibodies); syphilis or human immunodeficiency virus (HIV) infection.
• Presence of any indwelling catheter or drainage tube (such as percutaneous nephrostomy, indwelling Foley catheter, bile drainage tube, or pleural/peritoneal/pericardial catheter); use of specialized central venous access devices like Port-A-Cath® or Hickman® catheters is allowed.
• History of using any of the following medications:
• Lenalidomide within 1 day before the apheresis.
• Idelalisib (oral PI3Kδ inhibitor) within 2 days before the apheresis.
• Short-acting targeted therapy (like tyrosine kinase inhibitors) within 72 hours before the apheresis.
• Venetoclax (BCL-2 inhibitor) within 4 days before the apheresis.
• Long-acting growth factors (like pegylated filgrastim) within 14 days before the apheresis, or short-acting growth factors or mobilization agents (like G-CSF/filgrastim, plerixafor) within 5 days before the apheresis.
• Pharmacological doses of corticosteroids (\>5mg/day of prednisone or equivalent doses of other corticosteroids) or other immunosuppressive agents within 7 days before enrollment.

Sponsors & Collaborators

• Shanghai First Song Biotechnology Co., LTD: lead

Study Sites (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

RECRUITING

MeSH Terms

Conditions

Lymphoma

Interventions

fludarabine; Cyclophosphamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Huaying Ruan

  Shanghai First Song Biotechnology Co., LTD

  STUDY CHAIR

• Jian Ge, MD

  The First Affiliated Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huaying Ruan

CONTACT

+86-021-50565587; reta.r@triarmbio.com

Study Design

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

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 1, 2024
• Study Start: August 24, 2023
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)