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Status unknownNCT03271515Updated Jan 20, 2021

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

A Phase 1 interventional study of anti-CD19 anti-CD20 Bispecific CAR-T in Leukemia and Lymphoma, sponsored by Beijing Doing Biomedical Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-01-20.

Sponsored by Beijing Doing Biomedical Co., Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Leukemia
  • Lymphoma

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Keywords

  • leukemia
  • lymphoma
  • CAR-T
  • bispecific
  • CD20
  • CD19
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • 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

Interventions

  • Biologicalanti-CD19 anti-CD20 Bispecific CAR-T

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

05

What researchers measure

Primary outcomes

  1. Antitumor Effects

    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 outcomes

  1. 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.

    Time frame: 3 years

  2. 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.

    Time frame: 3 years

06

Study locations

1 site
  • Hebei Yanda Ludaopei Hospital
    Sanhe, Hebei 065200, China
    • Gai liyun, Docter · Contact · 086-13269099630
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03271515
Lead sponsor
Beijing Doing Biomedical Co., Ltd.
Responsible party
Sponsor
First posted
Sep 5, 2017
Start date
Mar 1, 2021 (estimated)
Primary completion
Mar 1, 2022 (estimated)
Completion
Mar 1, 2023 (estimated)
Last update
Jan 20, 2021

Study contacts

gai liyun
Contact
liyun_gai@doingtimes.com
086-13269099630
li gangyi
Contact
gangyi_li@doingtimes.com
086-13901106501
li gangyi
study chair · Beijing Doing Biomedical Co., Ltd.

Oversight

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

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This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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