Clinical Study of CAR-T Technology for the Treatment of Relapsed Refractory Malignant Haematological Tumours

NCT06238336 | Unknown Phase 2

• 1 other identifier: YXLL-2019-114
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The trial is designed as an early exploratory single-centre, open, single-arm clinical trial. The trial is planned to evaluate the safety and efficacy of CAR-T for the treatment of relapsed refractory malignant haematological tumours. The trial is divided into five visit periods as follows: screening period, non-myeloablative pretreatment, short-term follow-up period, mid-term follow-up period and exit visit.

Conditions

Hematological Malignancy

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-related adverse events

  Adverse events associated with CAR-T therapy, serious adverse events and clinically significant laboratory test abnormalities.

  Up to 36 months

Secondary Outcomes (6)

• CAR-T amplification levels

  Up to 36 months

• Duration of the CAR-T

  Up to 36 months

• Lymphocyte abatement

  Up to 36 months

• Objective Response Rate (ORR)

  Up to 6 months

• Progression-free survival(PFS)

  Up to 36 months

Study Arms (1)

CAR-T cell therapy

EXPERIMENTAL

Dose climbing started with 1.0\*10\^6/kg back infusion, 3 patients per dose group, if there is no adverse reaction the dose can be increased to 2.0\*10\^6/kg, 4.0\*10\^6/kg, the maximum dose can be extended the study.

Drug: CAR-T cell therapy

Interventions

CAR-T cell therapy DRUG

The application of CAR-T therapy in the clinic generally involves the in vitro preparation and in vivo infusion of CAR-T, and the specific experimental process is divided into five steps: (1) isolation of T cells from the peripheral blood of the cancer subjects or single harvested single nucleated cells; (2) use of genetic engineering to transfer CAR structural genes that can specifically recognise the tumour cells into the T cells; (3) in vitro cultivation and expansion of CAR-T cells to the desired infusion dose (4) Non-myeloablative chemotherapy is administered prior to the infusion of CAR-T cells, which is used to remove immunosuppressive cells and reduce the tumour load so as to enhance the efficacy of the treatment; (5) CAR-T cells are infused according to the expected dosage, and the efficacy of the treatment is observed and the adverse reactions are closely monitored.

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 or their legal guardians voluntarily participate and sign an informed consent form;
• male or female patients aged 14 to 70 years (inclusive);
• be diagnosed as malignant haematological tumour by pathological and histological examination;
• have a measurable or evaluable lesion;
• the patient has good function of major tissues and organs:
• (1) Liver function: ALT/AST \<3 times upper limit of normal (ULN) and total bilirubin ≤34.2 μmol/L; (2) Renal function: creatinine \<220 μmol/L; (3) Lung function: room oxygen saturation ≥95%; (4) Cardiac function: left ventricular ejection fraction (LVEF) ≥40%. (6) Patient's peripheral superficial venous blood flow is smooth and can meet the demand of intravenous drip; 7. patients with ECOG score ≤2 and expected survival time ≥3 months.

You may not qualify if:

• Women who are pregnant (positive urine/blood pregnancy test) or breastfeeding;
• men or women who are planning to conceive within the last 1 year;
• patients who cannot guarantee effective contraception (condoms or birth control pills, etc.) within 1 year of enrolment;
• patients with uncontrolled infections within 4 weeks prior to enrolment;
• active viral hepatitis B/C;
• patients with HIV infection;
• patients with severe autoimmune diseases or immunodeficiency diseases;
• patients who are allergic to large molecule biopharmaceuticals such as antibodies or cytokines;
• patients who have participated in other clinical trials within 6 weeks prior to enrolment;
• the patient has used hormones systematically within 4 weeks prior to enrolment (except for patients using inhaled hormones);
• the patient has a psychiatric disorder
• the patient has substance abuse/addiction;
• other conditions that, in the judgement of the investigator, make the patient unsuitable for enrolment.

Sponsors & Collaborators

• Shanxi Bethune Hospital: lead

Study Sites (1)

ShanxiBethuneH

Taiyuan, Shanxi, 030032, China

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Xiaomin Zhang

  Shanxi Bethune Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liangming Ma

CONTACT

13513629908; maliangming620928@163.com

Xiaomin Zhang

CONTACT

13513629908; sxdyyky@126.com

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: January 15, 2024
• First Posted: February 2, 2024
• Study Start: June 15, 2020
• Primary Completion: November 15, 2025
• Study Completion: December 20, 2025
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)