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Status unknownNCT03312205Updated Jan 9, 2019

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

A Phase 1/2 interventional study of Autologous CAR-T cells in Leukemia, Lymphoma and Multiple Myeloma of Bone (Diagnosis), sponsored by Hebei Senlang Biotechnology Inc., Ltd.. Status unknown at 1 site in China. Open to participants aged 1 Year to 70 Years. Per ClinicalTrials.gov, last updated 2019-01-09.

Sponsored by Hebei Senlang Biotechnology Inc., Ltd. · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
1 Year to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

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03

Who can participate

Ages eligible
1 Year to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Autologous CAR-T cells

    Patients will be be treated with autologous CAR-T cells

    Biological: Autologous CAR-T cells

Interventions

  • BiologicalAutologous 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.

05

What researchers measure

Primary outcomes

  1. 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

  1. CAR-T cell persistence

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

    Time frame: Up to 24 months

06

Study locations

1 of 1 sites recruiting
  • Hebei Yanda Ludaopei Hospital
    Langfang, Hebei 065000, China
    • Peihua Lu, PhD & MD · Contact · peihua_lu@126.com · 008618611636172
    • Peihua Lu, PhD & MD · Principal investigator
    • Jianqiang Li, PhD & MD · Sub investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03312205
Lead sponsor
Hebei Senlang Biotechnology Inc., Ltd.
Collaborators
Hebei Yanda Ludaopei Hospital, Beijing Lu Daopei Hospital
Responsible party
Sponsor
First posted
Oct 17, 2017
Start date
Aug 29, 2017
Primary completion
Aug 29, 2019 (estimated)
Completion
Aug 29, 2023 (estimated)
Last update
Jan 9, 2019

Study contacts

Peihua Lu, PhD & MD
Contact
peihua_lu@126.com
18611636172
Jianqiang Li, PhD & MD
Contact
limmune@gmail.com
008615511369555
Peggy Lu, PhD & MD
study chair · Hebei Yanda Ludaopei Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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