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

November 8, 2019 updated by: iCell Gene Therapeutics

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Chengdu, China
        • Recruiting
        • Chengdu Military General Hospital
      • Shanghai, China
        • Recruiting
        • Peking University Shenzhen Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CD20-CD19 cCAR T cells
CD20-CD19 cCAR T cells transduced with a lentiviral vector to express two distinct units of anti-CD20 and CD19 CARs
Biological: CD20-CD19 cCAR T cells
CD20-CD19 cCAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
28 days
Type of dose-limiting toxicity (DLT)
Time Frame: 28 days
28 days
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 1 year
1 year
Progression-free survival (PFS)
Time Frame: 1 year
1 year
Overall Response Rate (ORR)
Time Frame: 1 year
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iCell Gene Therapeutics

Collaborators

Peking University Shenzhen Hospital
iCAR Bio Therapeutics Ltd.
Chengdu Military General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2018

Primary Completion (ANTICIPATED)

September 30, 2020

Study Completion (ANTICIPATED)

September 30, 2020

Study Registration Dates

First Submitted

November 6, 2019

First Submitted That Met QC Criteria

November 6, 2019

First Posted (ACTUAL)

November 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 12, 2019

Last Update Submitted That Met QC Criteria

November 8, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICG133-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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