An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti CD30 CAR T Cells in Patients With CD30+ Relapsed/Refractory Lymphoma

NCT05208853 | Unknown Early Phase 1

• 1 other identifier: ARM002-CN-2021-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, open label, single dose study of anti CD30 CAR-T cells injection in treatment of patients with relapsed/refractory CD30+ lymphoma.

Conditions

Hodgkin Lymphoma; NK/T Cell Lymphoma; Peripheral T Cell Lymphoma, Unspecified; Angioimmunoblastic T-cell Lymphoma; Anaplastic Large Cell Lymphoma; Diffuse Large B Cell Lymphoma; Mediastinal B-Cell Diffuse Large Cell Lymphoma; Gray Zone Lymphoma

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose (MTD)

  Maximum Tolerated Dose

  within 4 weeks after infusion

• AE and SAE

  To evaluate safety of the cell therapy. Adverse event and serious adverse event.

  day 0 to month 12

Secondary Outcomes (5)

• Objective Response Rate, ORR

  day 0 to month 12

• Disease control rate, DCR

  day 0 to month 12

• Duration of remission, DOR

  day 0 to month 12

• Progression-free survival, PFS

  day 0 to month 12

• Overall survival, OS

  day 0 to month 12

Study Arms (1)

Anti CD30 CAR T cells

EXPERIMENTAL

Patients receive anti CD30 CAR-T cells on day 0 after lymphodepleting treatment. Route of administration: Intravenous injection. Lymphodepletion conditioning: Lymphodepletion will be conducted several days prior to anti CD30 CAR-T cells infusion.

Biological: Anti CD30 CAR-T Cell Injection

Interventions

Anti CD30 CAR-T Cell Injection BIOLOGICAL

After enrollment, subjects complete the apheresis, then complete the lymphodepletion, and then receive the dose escalation test: 1.5×10\^7 cells，1.5×10\^8 cells，5× 10\^8 cells. Drug: Fludarabine Fludarabine is used for lymphodepletion. Drug: Cyclophosphamide Cyclophosphamide is used for lymphodepletion

Anti CD30 CAR T cells

Eligibility Criteria

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

You may qualify if:

• Patients must meet all of the following criteria to be included in the group:
• Understand and sign the informed consent form, and voluntarily participate in clinical study;
• years old, no gender limit;
• Patients with CD30+ lymphoma have received at least 2-line systemic treatment in the past and who have relapsed or are refractory, including but not limited to:
• Hodgkins lymphoma;
• Mature T-cell lymphoma, including but not limited to non-specific peripheral T cell lymphoma, angioimmunoblastic T-cell lymphoma, NK/T-cell lymphoma, anaplastic large-cell lymphoma;
• Diffuse large B-cell lymphoma, including but not limited to mediastinal B-cell lymphoma, gray zone lymphoma;
• Other lymphocytic proliferative tumors;
• Patients Eastern Cooperative Oncology Group (ECOG) physical status score must be 0 or 1;
• Patients with sufficient venous access (for apheresis), and no other contraindications for blood cell separation;
• According to the revised version of the efficacy evaluation of malignant lymphoma (2018 lugano standard), Patients should be fluorodeoxyglucose-PET positive and with at least on measurement lesion: long axis of the lesion is ≥ 1.5 cm, or the long axis is 1.0-1.5 cm and short axis ≥1.0cm;
• Patients should meet the following laboratory exam requirements during screening, and haven't received cell growth factor (long-acting colony stimulating factor (G-CSF/PEG-CSF) , requires an interval of 2 weeks, except for recombinant erythropoietin) within 7 days before hematological evaluation screening;
• The absolute value of neutrophils ≥ 1.0×10\^9/L;
• Hemoglobin ≥ 90g/L (without red blood cell transfusion within 14 days), hemoglobin in patients with bone marrow involvement ≥ 75g/L;
• Platelets in patients without bone marrow involvement≥75×10\^9/L, and patients in platelets with bone marrow involvement ≥ 50×10\^9/L;

You may not qualify if:

• Patients cannot participate in this study if they meet any of the following conditions:
• Patients have a history of allergies to any component in cell therapy products.
• Patients received any CAR-T cell product or other genetically modified T cell therapy in the past.
• Patients received autologous or allogeneic hematopoietic stem cell transplantation within 3 months.
• Patients suffering from other malignant tumors in the past or present (except for skin basal cell carcinoma, breast/cervix carcinoma in situ and other malignant tumors that have not been treated and effectively controlled in the past five years).
• Patients who have received continuous systemic steroids (prednisone\> 5 mg/day or equivalent doses of other hormones) or other immunosuppressive agents within 14 days before apheresis, except those who have recently or currently used inhaled steroids.
• Patients with Hepatitis B (positive hepatitis B virus surface antigen and/or positive hepatitis B core antibody and hepatitis B DNA \> 10\^3 copies/mL) and Hepatitis C (positive hepatitis C antibody test).
• Patients with syphilis, human immunodeficiency virus (HIV) infection (HIV positive).
• Patients with hyponatremia and/or hypokalemia, blood sodium \< 125 mmol/L and/or blood potassium \< 3.5 mmol/L (Except that blood sodium and/or potassium were restored above this level by sodium and/or potassium supplementation before participating in this study).
• Patients was known or existing primary or metastatic central nervous system lymphoma, or with any other central nervous system disease (such as seizures, cerebral ischemia/hemorrhage, dementia, etc.).
• According to the heart function classification standard of New York Heart Association (NYHA), those with grade III or IV cardiac insufficiency; Cardiac ejection fraction is lower than 50% or lower than the lower limit of the laboratory test value range of the research center, or ECG is significantly abnormal.
• Patients with severe respiratory diseases at the time of enrollment (before apheresis), such as interstitial lung disease, active tuberculosis, etc., investigator considered unsuitable for enrollment.
• According to the judgment of the investigator, patients with any serious or uncontrollable systemic disease, systemic complications, other serious concurrent diseases (such as hematophilic syndrome, etc.), special tumor conditions may unsuitable for entering this study or affect Protocol compliance, or significant interference with the correct evaluation of the safety, toxicity, and effectiveness of the study drug.
• Major surgery has been performed within 4 weeks before apheresis (the definition of major surgery refers to the level 3 and level 4 surgery specified in the "Administrative Measures for the Clinical Application of Medical Technology");Or has not fully recovered from any previous invasive operation.
• Patients received systemic chemotherapy within 3 weeks before apheresis, or the toxicity of previous anti-tumor therapy has not recovered ( \> CTCAE v5.0 grade 1), except for hair loss and pigmentation.

Sponsors & Collaborators

• Zhejiang University: lead
• Shanghai First Song Therapeutics Co., Ltd: collaborator

Study Sites (1)

The First Affiliated Hospital, College of medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, Extranodal NK-T-Cell; Lymphoma, T-Cell; Immunoblastic Lymphadenopathy; Lymphoma, Large-Cell, Anaplastic; Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphadenopathy; Lymphoma, B-Cell

Study Officials

• Huang He, PhD

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huang He, PhD

CONTACT

86-13605714822; hehuangyu@126.com

Yongxian Hu, PhD

CONTACT

86-15957162012; huyongxian2000@aliyun.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: January 26, 2022
• Study Start: February 10, 2022
• Primary Completion: February 10, 2022
• Study Completion: February 10, 2022
• Last Updated: January 26, 2022

Record last verified: 2022-01

Locations

CN (1)