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Immunotherapy With Bispecific CAR-T Cells for B-Cell Lymphoma, ALL and CLL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03271515
Recruitment Status : Not yet recruiting
First Posted : September 5, 2017
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Beijing Doing Biomedical Co., Ltd.

Study Description
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Brief Summary:
This study aims to evaluate the safety, efficacy and duration of response of anti-CD19 anti-CD20 Bispecific Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD19+ and CD20+ haematological malignancies.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Biological: anti-CD19 anti-CD20 Bispecific CAR-T 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 CD20 Chimeric Antigen Receptor (CAR) T-cells (CD19 CAR T-cells) in patients with high risk, relapsed CD19+ and CD20+haematological malignancies (Leukemia and lymphoma). Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD19 CD20 CAR T-cells. Patients will receive the CD19 CD20 CAR T-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD19 CD20 CAR T-cells in patients with high risk relapsed CD19+ malignancies.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of T Cells Expressing an Anti-CD19 and Anti-CD20 Bispecific Chimeric Receptor in Patients With B Cell Malignancies
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
No Intervention: conventional therapy
patients accept conventional radioactive and chemical therapy.
Experimental: anti-CD19 anti-CD20 Bispecific CAR-T
patients accept transfusion of anti-CD19 anti-CD20 Bispecific CAR-T cells.
 Biological: anti-CD19 anti-CD20 Bispecific CAR-T
patients accept transfusion of anti-CD19 anti-CD20 Bispecific CAR-T cells.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Survival time of Anti-CD19 Anti-CD20 CAR T cells in vivo. [ Time Frame: 3 years ]
    To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.

  2. Adverse events of each patient. [ Time Frame: 3 years ]
    Determine the toxicity profile of the CD19 CD20 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.


Eligibility Criteria
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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 or CD20 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 trial.

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.
Contacts and Locations
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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): NCT03271515


Contacts
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Contact: gai liyun 086-13269099630 liyun_gai@doingtimes.com
Contact: li gangyi 086-13901106501 gangyi_li@doingtimes.com

Locations
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China, Hebei
Hebei Yanda Ludaopei Hospital
Sanhe, Hebei, China, 065200
Contact: Gai liyun, Docter    086-13269099630      
Sponsors and Collaborators
Beijing Doing Biomedical Co., Ltd.
Investigators
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Study Chair: li gangyi Beijing Doing Biomedical Co., Ltd.
More Information
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Responsible Party: Beijing Doing Biomedical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03271515    
Other Study ID Numbers: Doing-006
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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-T
 bispecific
CD20
CD19
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases