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

NCT03312205 | Unknown Phase 1

• 1 other identifier: daopeicart
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia; Lymphoma; Multiple Myeloma of Bone (Diagnosis)

Outcome Measures

Primary Outcomes (1)

• Tumor load

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

  Up to 24 months

Secondary Outcomes (1)

• CAR-T cell persistence

  Up to 24 months

Study Arms (1)

Autologous CAR-T cells

EXPERIMENTAL

Patients will be be treated with autologous CAR-T cells

Biological: Autologous CAR-T cells

Interventions

Autologous CAR-T cells BIOLOGICAL

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.

Autologous CAR-T cells

Eligibility Criteria

• Age: 1 Year - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Be diagnosed a kind of Relapsed or Refractory Haematopoietic and Lymphoid Malignancies:
• ECOG score≤2;
• To be aged 1 to 70 years;
• More than a month lifetime from the consent signing date.

You may not qualify if:

• Serious cardiac insufficiency, left ventricular ejection fraction\<50%;
• Has a history of severe pulmonary function damaging;
• Merging other progressing malignant tumor;
• Merging uncontrolled infection;
• Merging the metabolic diseases (except diabetes);
• Merging severe autoimmune diseases or immunodeficiency disease;
• Patients with active hepatitis B or hepatitis C;
• Patients with HIV infection;
• Has a history of serious allergies on Biological products (including antibiotics);
• Has acute GvHD on allogeneic hematopoietic stem cell transplantation patients after stopping immunosuppressants a month;
• Pregnancy or lactation women;
• Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.

Sponsors & Collaborators

• Hebei Senlang Biotechnology Inc., Ltd.: lead
• Hebei Yanda Ludaopei Hospital: collaborator
• Beijing Lu Daopei Hospital: collaborator

Study Sites (1)

Hebei Yanda Ludaopei Hospital

Langfang, Hebei, 065000, China

RECRUITING

MeSH Terms

Conditions

Leukemia; Lymphoma; Disease

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peggy Lu, PhD & MD

  Hebei Yanda Ludaopei Hospital

  STUDY CHAIR

Central Study Contacts

Peihua Lu, PhD & MD

CONTACT

18611636172; peihua_lu@126.com

Jianqiang Li, PhD & MD

CONTACT

008615511369555; limmune@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 17, 2017
• Study Start: August 29, 2017
• Primary Completion: August 29, 2019
• Study Completion: August 29, 2023
• Last Updated: January 9, 2019

Record last verified: 2019-01

Locations

CN (1)