CD19 Targeted Universal Chimeric Antigen Receptor T Cells Injection for CD19+ Refractory/Relapsed B-cell Malignancies

May 8, 2023 updated by: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of Anti-CD19 Universal CAR-T Cells in the Treatment of CD19+ Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia and Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

It is a single-arm, open-label clinical study to assess the safety and efficacy of the Anti-CD19 Universal CAR-T Cells injection for patients with CD19+ refractory/relapsed B cell acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study consists of the following periods: screening, lymphodepletion, CAR-T cell infusion, safety follow up, and long term follow-up.

Study Type

Interventional

Enrollment (Anticipated)

15

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 Contact

Study Locations

  • China
    • Yunnan
      • Kunming, Yunnan, China, 650000
        • Recruiting
        • 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
        • Contact:

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

14 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Eastern Cooperative Oncology Group Performance Status of 0 or 1；
  2. Expected survival time ≥12 weeks;
  3. Adequate hematological, renal and liver function;
  4. Subjects understand and voluntarily sign the informed consent form.

Key Exclusion Criteria:

  1. Positive for any of the following etiological tests: HIV, HBV, HCV, TPPA ;
  2. Cyclophosphamide or fludarabine is contraindicated for subjects ;
  3. Active central nervous system (CNS) involvement by malignancy；
  4. Active infection.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anti-CD19 Universal CAR-T Cells injection
Anti-CD19 Universal CAR-T Cells injection will be administered by vein after lymphodepletion .
Biological: Anti-CD19 Universal CAR-T Cells injection
Anti-CD19 Universal CAR-T Cells injection will be administered by vein after lymphodepletion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose Limiting Toxicities
Time Frame: Up to 4 weeks after CAR-T infusion
Incidence of dose-limiting toxicities as protocol-defined
Up to 4 weeks after CAR-T infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: At 4,12,24 weeks after CAR-T infusion
Objective response rate after CAR-T infusion
At 4,12,24 weeks after CAR-T infusion

Collaborators and Investigators

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

Sponsor

920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

Collaborators

Gracell Biotechnology Shanghai Co., Ltd.
Kunming Hope of Health Hospital

Investigators

  • Principal Investigator: Sanbin Wang, Professor, 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

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)

September 29, 2021

Primary Completion (Anticipated)

August 31, 2024

Study Completion (Anticipated)

November 30, 2024

Study Registration Dates

First Submitted

October 25, 2021

First Submitted That Met QC Criteria

October 25, 2021

First Posted (Actual)

November 3, 2021

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC011-411

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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