Clinical Study on CAR-T Targeting Igβ Targets in Refractory Relapsed Non-Hodgkin's Lymphoma

NCT05312476 | Unknown Phase 2

• 1 other identifier: R/R B-NHL 02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of this study will evaluate the safety, tolerability and preliminary efficacy of chimeric antigen receptor T cells (CAR-T) targeting Igβ targets in patients with Igβ-positive refractory relapsed non-Hodgkin's lymphoma.

Conditions

Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

Keywords

CAR-T Cells targeting Igβ targets; Relapsed Refractory B-cell Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (2)

• DLT

  DLT occurring within 28 days of the last dose.

  Measured from start of treatment until 28 days after last dose

• Adverse events profile

  Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 will be tabulated.

  Measured from start of treatment until 28 days after last dose

Secondary Outcomes (8)

• Objective Response Rate

  up to 3 months

• Duration of Response

  up to 12 months

• Progression-free survival

  up to 12 months

• Overall Survival

  up to 12 months

• Peak Plasma Concentration

  Measured from start of treatment until 28 days after last dose

Study Arms (1)

Chimeric Antigen Receptor T Cells (CAR-T) Targeting Igβ Targets

EXPERIMENTAL

Chimeric antigen receptor T cells targeting Igβ targets (CAR-T)

Drug: Chimeric Antigen Receptor T Cells (CAR-T) Targeting Igβ Targets

Interventions

Chimeric Antigen Receptor T Cells (CAR-T) Targeting Igβ Targets DRUG

1. Dose escalation studies:3 dose groups in total: expect 3-6 cases in each group, and dose set at 1×106/kg，3×106/kg，6×106/kg. 2. Dose extension study:3 cases (1 dose group).

Also known as: Chimeric antigen receptor-modified T (CAR-T) cell therapy

Chimeric Antigen Receptor T Cells (CAR-T) Targeting Igβ Targets

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary signing of informed consent and good compliance.
• Age ≥ 6 years.
• Previously treated with 2 or more lines of therapy.
• Has a measurable target lesion.
• ECOG 0-1#.
• Have appropriate organ function, subject to the following criteria (except for abnormal liver function due to tumor infiltration): AST≤3 times upper limit of normal#ALT≤3 times upper limit of normal# TB≤2 times ULN, unless combined with Gilbert's syndrome #Patients with Gilbert's syndrome with TB≤ 3 times ULN and DB≤ 1.5 times ULN can be include # Scr ≤1.5 times ULN or CCr≥60 ml/min# Lung function≤Level 1; dyspnea(CTCAE v5.0),and blood oxygen saturation without oxygen absorption\> 91%# INR≤1.5 times ULN# aPTT≤1.5 times ULN.
• negative blood/urine pregnancy test in women of childbearing age within 7 days prior to cell infusion, and any male and female patients of childbearing potential must agree to use an effective method of contraception throughout the study and for at least six months after the study treatment is administered.
• Pass the T-cell amplification test.
• Have adequate venous access to single or venous blood and no other contraindications to leukocyte isolation.
• Estimated survival time ≥3 months.

You may not qualify if:

• Prior malignancy (other than Relapsed Refractory B-cell Non-Hodgkin's Lymphoma), except for cured malignant tumors with no active lesions for 3 years; Adequate treatment of inactive lesions in non-melanoma skin cancer, malignant tonsilloma or carcinoma in situ.
• Have used immunosuppressants or hormones within 2 weeks prior to signing informed consent, or plan to have to use immunosuppressants or high-dose hormones (e.g. prednisone \>15mg) after signing informed consent, specifically systemic treatment, excluding treatment with topical or inhaled corticosteroids.
• The presence of bacterial, fungal, viral, mycoplasma or other types of infection that, in the judgment of the investigator, are difficult to control.
• HIV, Syphilis or COVID-19 infection.
• Active hepatitis B or active hepatitis C.
• Previous or current CNS disease other than this disease, such as seizures, cerebrovascular ischaemia/hemorrhage, dementia, cerebellar disease or any CNS-related autoimmune disease.
• A history of cardiac angioplasty or stent placement within 12 months prior to signing the informed consent form, or a history of myocardial infarction, unstable angina or other clinically significant heart disease.
• Patients with primary immunodeficiency.
• Have had a severe tachyphylaxis to any of the drugs to be used in this study.
• Live vaccination within 6 weeks prior to screening.
• Pregnant or breasting-feeding women.
• Active autoimmune diseases.
• Active acute or chronic graft-versus-host disease (GVHD) at the time of signing the informed consent form.
• Received an allogeneic hematopoietic stem cell transplant within 6 months prior to signing the informed consent form.
• Participated in an investigational clinical trial of any other drug within 30 days prior to signing the informed consent form.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

Immunotherapy, Adoptive; Cell- and Tissue-Based Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Depei Wu, M.D

  The First Affiliated Hospital of Soochow University

  STUDY CHAIR

Central Study Contacts

Caixia Li, M.D

CONTACT

+86 512 67781856; licaixia@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 5, 2022
• Study Start: February 10, 2022
• Primary Completion: February 10, 2025
• Study Completion: February 10, 2025
• Last Updated: April 5, 2022

Record last verified: 2022-03

Locations

CN (1)