CD19 CARvac T Cells for Patients With Relapsed / Refractory B Cell Malignancies

NCT ID: NCT04156243

Last Updated: 2019-11-12

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2020-02-28

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 CD19 CARvac in patients with relapsed and/or refractory B cell malignancies.

Detailed Description

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CD19 CARvac is a chimeric antigen receptor immunotherapy treatment designed to treat

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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CD19 CARvac T cells

CD19 CARvac T cells transduced with a lentiviral vector to express

Group Type EXPERIMENTAL

CD19 CARvac T cells

Intervention Type BIOLOGICAL

CD19 CARvac 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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CD19 CARvac T cells

CD19 CARvac 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. Patients have exhausted standard therapeutic options
3. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks
4. Female must be not pregnant during the study

Exclusion Criteria

1. Prior solid organ transplantation
2. Potentially curative therapy including chemotherapy or hematopoietic cell transplant
3. Prior treatment with BCMAxCD3 or CS1xCD3 bispecific agents
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Shenzhen Hospital

OTHER

Sponsor Role collaborator

Chengdu Military General Hospital

OTHER

Sponsor Role collaborator

iCAR Bio Therapeutics Ltd.

INDUSTRY

Sponsor Role collaborator

iCell Gene Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hongyu Zhang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University Shenzhen Hospital

Fang Liu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The General Hospital of Western Theater Command

Locations

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The General Hospital of Western Theater Command

Chengdu, , China

Site Status RECRUITING

Peking University Shenzhen Hospital

Shenzhen, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kevin Pinz

Role: CONTACT

6315386218

Facility Contacts

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Fang Liu, MD, PhD

Role: primary

Role: backup

Hongyu Zhang, MD, PhD

Role: primary

Role: backup

References

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Liu F, Sha S, Ma G, Su Y, Xiong Y, He G, Li Y, Hanes WM, Tse W. Treatment of CML-transformed B Cell Acute Lymphoblastic Leukemia (B-ALL) in Adults with Anti-CD19 Chimeric Antigen Receptor T Cell (CAR T) Therapy. Stem Cell Rev Rep. 2020 Dec;16(6):1356-1358. doi: 10.1007/s12015-020-10008-7. No abstract available.

Reference Type DERIVED
PMID: 32840736 (View on PubMed)

Other Identifiers

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ICG134-001

Identifier Type: -

Identifier Source: org_study_id

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