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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03312205
• Other study ID #: daopeicart
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 29, 2017
• Est. completion date: August 29, 2023

Study information

• Verified date: January 2019
• Source: Hebei Senlang Biotechnology Inc., Ltd.
• Contact: Peihua Lu, PhD & MD
• Phone: 18611636172
• Email: peihua_lu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 29, 2023
• Est. primary completion date: August 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma of Bone (Diagnosis)

Intervention

Biological:
• Autologous CAR-T cells
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.

Locations

Country	Name	City	State
China	Hebei Yanda Ludaopei Hospital	Langfang	Hebei

Sponsors (3)

Lead Sponsor	Collaborator
Hebei Senlang Biotechnology Inc., Ltd.	Beijing Ludaopei Hospital, Hebei Yanda Ludaopei Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor load	Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.	Up to 24 months
Secondary	CAR-T cell persistence	CAR-T cell persistence will be quantified with flow cytometry and qPCR	Up to 24 months