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

Primary Purpose

Leukemia, Lymphoma

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
anti-CD19 anti-CD20 Bispecific CAR-T
Sponsored by
Beijing Doing Biomedical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring leukemia, lymphoma, CAR-T, bispecific, CD20, CD19

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hebei Yanda Ludaopei Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

conventional therapy

anti-CD19 anti-CD20 Bispecific CAR-T

Arm Description

patients accept conventional radioactive and chemical therapy.

patients accept transfusion of anti-CD19 anti-CD20 Bispecific CAR-T cells.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Survival time of Anti-CD19 Anti-CD20 CAR T cells in vivo.
To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.
Adverse events of each patient.
Determine the toxicity profile of the CD19 CD20 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.

Full Information

First Posted
August 31, 2017
Last Updated
January 19, 2021
Sponsor
Beijing Doing Biomedical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03271515
Brief Title
Immunotherapy With Bispecific CAR-T Cells for B-Cell Lymphoma, ALL and CLL
Official Title
Phase I Study of T Cells Expressing an Anti-CD19 and Anti-CD20 Bispecific Chimeric Receptor in Patients With B Cell Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Doing Biomedical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma
Keywords
leukemia, lymphoma, CAR-T, bispecific, CD20, CD19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional therapy
Arm Type
No Intervention
Arm Description
patients accept conventional radioactive and chemical therapy.
Arm Title
anti-CD19 anti-CD20 Bispecific CAR-T
Arm Type
Experimental
Arm Description
patients accept transfusion of anti-CD19 anti-CD20 Bispecific CAR-T cells.
Intervention Type
Biological
Intervention Name(s)
anti-CD19 anti-CD20 Bispecific CAR-T
Intervention Description
patients accept transfusion of anti-CD19 anti-CD20 Bispecific CAR-T cells.
Primary Outcome Measure Information:
Title
Antitumor Effects
Description
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
Time Frame
Every 3 months post treatment up to 24 months
Secondary Outcome Measure Information:
Title
Survival time of Anti-CD19 Anti-CD20 CAR T cells in vivo.
Description
To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.
Time Frame
3 years
Title
Adverse events of each patient.
Description
Determine the toxicity profile of the CD19 CD20 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphoblastic leukemia(CLL) and non-hodgkin lymphoma. KPS>60. Life expectancy>3 months. Gender unlimited, age from 18 years to 70 years. CD19 or CD20 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry. Patients who have failed at least one line of a standard treatment. No serious mental disorder. 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). No other serious diseases(autoimmune disease, immunodeficiency etc.). No other tumors. Patients volunteer to participate in the research. 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: KPS<50. Patients are allergic to cytokines. Central nervous system leukemia within 28 days. Uncontrolled active infection. Acute or chronic GVHD. Treated with T cell inhibitor. Pregnancy and nursing females. HIV/HBV/HCV Infection. Other situations we think improper for the research.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
gai liyun
Phone
086-13269099630
Email
liyun_gai@doingtimes.com
First Name & Middle Initial & Last Name or Official Title & Degree
li gangyi
Phone
086-13901106501
Email
gangyi_li@doingtimes.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
li gangyi
Organizational Affiliation
Beijing Doing Biomedical Co., Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
Hebei Yanda Ludaopei Hospital
City
Sanhe
State/Province
Hebei
ZIP/Postal Code
065200
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gai liyun, Docter
Phone
086-13269099630

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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