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

Phase 1

• Conditions: Leukemia; Lymphoma; Multiple Myeloma of Bone (Diagnosis)
• Interventions: Biological: Autologous CAR-T cells

• Registration Number: NCT03312205
• Lead Sponsor: Hebei Senlang Biotechnology Inc., Ltd.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-08-29
• Study First Submitted: 2017-10-12
• Study First Submitted QC: 2017-10-12
• Study First Posted: 2017-10-17
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-09
• Primary Completion: 2019-08-29
• Study Completion: 2023-08-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous CAR-T cells	Autologous CAR-T cells	Patients will be be treated with autologous CAR-T cells

Primary Outcome Measures

Name	Time	Method
Tumor load	Up to 24 months	Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.

Secondary Outcome Measures

Name	Time	Method
CAR-T cell persistence	Up to 24 months	CAR-T cell persistence will be quantified with flow cytometry and qPCR

Trial Locations

Locations (1)

Hebei Yanda Ludaopei Hospital; 🇨🇳 Langfang, Hebei, China