CAR-T Cells for Relapsed or Refractory Haematopoietic and Lymphoid Malignancies

Hebei Senlang Biotechnology Inc., Ltd.50 enrolled

Overview

This is an open, single-arm, phase I/phase II clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of hematopoietic and lymphoid malignancies. A total of 50 patients are planned to be enrolled over a period of 2 years.

Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. Besides CD19, many other molecules such as CD22, CD30,BCMA, CLL-1, etc. may be potential in developing the corresponding CAR-T cells to treat patients whose tumors expressing those markers. Investigators have developed a high efficient platform for constructing different CARs and preclinical studies have demonstrated effective killing of corresponding target cells. In this study, investigators will evaluate their safety and efficacy in patients with different types of hematopoietic and lymphoid malignancies. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Leukemia Lymphoma Multiple Myeloma of Bone (Diagnosis)

Interventions

Autologous CAR-T cellsBIOLOGICAL

Patients will be drawn 50-100 ml blood to obtain enough peripheral blood mononuclear cells (PBMC) for CAR-T manufacturing. The T cells will be purified from the PBMC, transduced with CAR lentiviral vector, expanded in vitro and then frozen for future administration. Chemotherapy will then be given. Following tumor burden reassessment, CAR-T cells will be infused.

Eligibility

Sex: ALLMin age: 1 YearMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Be diagnosed a kind of Relapsed or Refractory Haematopoietic and Lymphoid Malignancies: 2. ECOG score≤2; 3. To be aged 1 to 70 years; 4. More than a month lifetime from the consent signing date. Exclusion Criteria: 1. Serious cardiac insufficiency, left ventricular ejection fraction\<50%; 2. Has a history of severe pulmonary function damaging; 3. Merging other progressing malignant tumor; 4. Merging uncontrolled infection; 5. Merging the metabolic diseases (except diabetes); 6. Merging severe autoimmune diseases or immunodeficiency disease; 7. Patients with active hepatitis B or hepatitis C; 8. Patients with HIV infection; 9. Has a history of serious allergies on Biological products (including antibiotics); 10. Has acute GvHD on allogeneic hematopoietic stem cell transplantation patients after stopping immunosuppressants a month; 11. Pregnancy or lactation women; 12. Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.

Locations (1)

Hebei Yanda Ludaopei Hospital

Langfang, Hebei, China

RECRUITING

Outcomes

Primary Outcomes

Tumor load

Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.

Time frame: Up to 24 months

Secondary Outcomes

CAR-T cell persistence

CAR-T cell persistence will be quantified with flow cytometry and qPCR

Time frame: Up to 24 months

Central Contacts

Peihua Lu, PhD & MD

CONTACT

18611636172 peihua_lu@126.com

Jianqiang Li, PhD & MD

CONTACT

008615511369555 limmune@gmail.com

Data from ClinicalTrials.gov

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