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Immunotherapy With CD19 CAR γδT-cells for B-Cell Lymphoma, ALL and CLL

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ClinicalTrials.gov Identifier: NCT02656147
Recruitment Status : Not yet recruiting
First Posted : January 14, 2016
Last Update Posted : September 5, 2017
Sponsor:
Information provided by (Responsible Party):
Beijing Doing Biomedical Co., Ltd.

Brief Summary:
This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric Antigen Receptor (CAR) redirected allogeneic γδT-cells in patients with high risk, relapsed CD19+ haematological malignancies.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Biological: Anti-CD19-CAR γδT Phase 1

Detailed Description:
This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19 Chimeric Antigen Receptor (CAR) γδT-cells (CD19 CAR γδT-cells) in patients with high risk, relapsed CD19+ haematological malignancies (Leukemia and lymphoma). Following informed consent and registration to the trial, Patients will receive the allogeneic CD19 CAR γδT-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD19 CAR γδT-cells in patients with high risk relapsed CD19+ malignancies.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of γδT Cells Expressing an Anti-CD19 Chimeric Receptor in Children and Young Adults With B Cell Malignancies
Estimated Study Start Date : October 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Experimental: 1
Acute lymphoblastic leukemia treated with chimeric antigen receptor modified γδT cells(Anti-CD19-CAR γδT) targeting CD19.
Biological: Anti-CD19-CAR γδT
Cells extracted, followed by induction chemotherapy before Anti-CD19-CAR γδT infusion (dose escalation.)

Experimental: Experimental: 2
Chronic lymphoblastic leukemia with chimeric antigen receptor modified γδT cells(Anti-CD19-CAR γδT) targeting CD19.
Biological: Anti-CD19-CAR γδT
Cells extracted, followed by induction chemotherapy before Anti-CD19-CAR γδT infusion (dose escalation.)

Experimental: Experimental: 3
Non-hodgkin lymphoma treated with chimeric antigen receptor modified γδT cells(Anti-CD19-CAR γδT) targeting CD19.
Biological: Anti-CD19-CAR γδT
Cells extracted, followed by induction chemotherapy before Anti-CD19-CAR γδT infusion (dose escalation.)




Primary Outcome Measures :
  1. Adverse events of each patient. [ Time Frame: 3 years ]
    Adverse events of each patient will be recorded and analysed.


Secondary Outcome Measures :
  1. Survival time of Anti-CD19 CAR γδT cells in vivo. [ Time Frame: 3 years ]
    PCR will be applied to analyse the survival time of Anti-CD19 CAR γδT cells in vivo.

  2. Antitumor Effects [ Time Frame: Every 3 months post treatment up to 24 months ]
    Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.

  3. Maximum tolerated dose (MTD) of CD19 targeted CAR γδT cells. [ Time Frame: 4 weeks ]
    Maximum tolerated dose (MTD) of CD19 targeted CAR γδT cells.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphoblastic leukemia(CLL) and non-hodgkin lymphoma.
  2. KPS>60.
  3. Life expectancy>3 months.
  4. Gender unlimited, age from 18 years to 70 years.
  5. CD19 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry.
  6. Patients who have failed at least one line of a standard treatment.
  7. No serious mental disorder.
  8. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr≤133umol/L).
  9. No other serious diseases(autoimmune disease, immunodeficiency etc.).
  10. No other tumors.
  11. Patients volunteer to participate in the research.
  12. Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to infusion.

Exclusion Criteria:

  1. KPS<50.
  2. Patients are allergic to cytokines.
  3. Central nervous system leukemia within 28 days.
  4. Uncontrolled active infection.
  5. Acute or chronic GVHD.
  6. Treated with T cell inhibitor.
  7. Pregnancy and nursing females.
  8. HIV/HBV/HCV Infection.
  9. Other situations we think improper for the research.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656147


Contacts
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Contact: Xie yanyun, master +8615601041145 yanyun_xie@doingtimes.com
Contact: Li gangyi, master +8613601204100 gangyi_li@doingtimes.com

Locations
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China
Beijing DOING Biomedical Co., Ltd
Beijing, China, 100021
Sponsors and Collaborators
Beijing Doing Biomedical Co., Ltd.
Investigators
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Study Chair: Li gangyi, master Beijing Doing Biomedical Co., Ltd.

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Responsible Party: Beijing Doing Biomedical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02656147     History of Changes
Other Study ID Numbers: Doing-004
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Beijing Doing Biomedical Co., Ltd.:
Leukemia
Lymphoma
CAR γδT

Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases