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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2020-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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B Cell Lymphoma B Cell Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

CD20-CD19 cCAR T cells

Intervention Type BIOLOGICAL

CD20-CD19 cCAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy

Interventions

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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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No