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

H

Hebei Senlang Biotechnology

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Multiple Myeloma of Bone (Diagnosis)
Lymphoma
Leukemia

Treatments

Biological: Autologous CAR-T cells

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03312205
daopeicart

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

1 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

  • 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.

Trial design

50 participants in 1 patient group

Autologous CAR-T cells
Experimental group
Description:
Patients will be be treated with autologous CAR-T cells
Treatment:
Biological: Autologous CAR-T cells

Trial contacts and locations

0

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Central trial contact

Peihua Lu, PhD & MD; Jianqiang Li, PhD & MD

Data sourced from clinicaltrials.gov

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