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CD20-CD19 Compound CAR (cCAR) T Cells for Patients With Relapsed /Refractory B Cell Malignancies

Primary Purpose

B Cell Lymphoma, B Cell Leukemia

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
CD20-CD19 cCAR T cells
Sponsored by
iCell Gene Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B Cell Lymphoma focused on measuring CD20, CD19, cCAR, Leukemia, Lymphoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis based on the World Health Organization (WHO) 2008
  2. Histologically demonstrate CD19 or CD20 expressing B cell lymphoma or B ALL
  3. Patients have exhausted standard therapeutic options
  4. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks
  5. Female must be not pregnant during the study

Exclusion Criteria:

  1. Patients declining to consent for treatment
  2. Prior solid organ transplantation
  3. Potentially curative therapy including chemotherapy or hematopoietic cell transplant
  4. Prior treatment with CD20xCD3 or CD19x3 bispecific agents

Sites / Locations

  • Chengdu Military General HospitalRecruiting
  • Peking University Shenzhen HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CD20-CD19 cCAR T cells

Arm Description

CD20-CD19 cCAR T cells transduced with a lentiviral vector to express two distinct units of anti-CD20 and CD19 CARs

Outcomes

Primary Outcome Measures

Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Type of dose-limiting toxicity (DLT)
Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Secondary Outcome Measures

Overall Response Rate (ORR)
Assessment of morphologic complete remission (CR), complete remission with incomplete recovery of counts (CR1), no residual disease as analyzed by flow cytometry analysis, and molecular remission by molecular studies
Progression-free survival (PFS)
Overall survival

Full Information

First Posted
November 6, 2019
Last Updated
November 8, 2019
Sponsor
iCell Gene Therapeutics
Collaborators
Peking University Shenzhen Hospital, Chengdu Military General Hospital, iCAR Bio Therapeutics Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04156178
Brief Title
CD20-CD19 Compound CAR (cCAR) T Cells for Patients With Relapsed /Refractory B Cell Malignancies
Official Title
Phase I, Interventional, Single Arm, Open Label, Treatment Study to Evaluate the Safety and Tolerability of CD20-CD19 cCAR in Patients With Relapsed and/or Refractory B Cell Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
iCell Gene Therapeutics
Collaborators
Peking University Shenzhen Hospital, Chengdu Military General Hospital, iCAR Bio Therapeutics Ltd.

4. Oversight

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

5. Study Description

Brief Summary
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD20-CD19 cCAR in patients with relapsed and/or refractory B cell malignancies.
Detailed Description
Clinical trials with CD19-directed CARs have achieved unprecedented remission rates as high as 90%. However, recent follow-up studies have shown a substantial portion of treated patients relapsed due to antigen escape. CD20-CD19 cCAR is a compound Chimeric Antigen Receptor (cCAR) immunotherapy with two distinct functional CAR molecules expressed on a T-cell, directed against the surface proteins CD20 and CD19. CD20-CD19 cCAR intends to target the mechanisms of single-CAR relapse, specifically antigen escape.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B Cell Lymphoma, B Cell Leukemia
Keywords
CD20, CD19, cCAR, Leukemia, Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CD20-CD19 cCAR T cells
Arm Type
Experimental
Arm Description
CD20-CD19 cCAR T cells transduced with a lentiviral vector to express two distinct units of anti-CD20 and CD19 CARs
Intervention Type
Biological
Intervention Name(s)
CD20-CD19 cCAR T cells
Intervention Description
CD20-CD19 cCAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy
Primary Outcome Measure Information:
Title
Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time Frame
28 days
Title
Type of dose-limiting toxicity (DLT)
Time Frame
28 days
Title
Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
Assessment of morphologic complete remission (CR), complete remission with incomplete recovery of counts (CR1), no residual disease as analyzed by flow cytometry analysis, and molecular remission by molecular studies
Time Frame
1 year
Title
Progression-free survival (PFS)
Time Frame
1 year
Title
Overall survival
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis based on the World Health Organization (WHO) 2008 Histologically demonstrate CD19 or CD20 expressing B cell lymphoma or B ALL Patients have exhausted standard therapeutic options Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks Female must be not pregnant during the study Exclusion Criteria: Patients declining to consent for treatment Prior solid organ transplantation Potentially curative therapy including chemotherapy or hematopoietic cell transplant Prior treatment with CD20xCD3 or CD19x3 bispecific agents
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Pinz
Phone
6315386218
Email
kevin.pinz@icellgene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongyu Zhang, MD, PhD
Organizational Affiliation
Peking University Shenzhen Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fang Liu, MD, PhD
Organizational Affiliation
Chengdu Military General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chengdu Military General Hospital
City
Chengdu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang Liu, MD, PhD
Facility Name
Peking University Shenzhen Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongyu Zhang, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

CD20-CD19 Compound CAR (cCAR) T Cells for Patients With Relapsed /Refractory B Cell Malignancies

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