Sequential Treatment With CD20/CD22/CD10-CART After CD19-CART Treatment Base on MRD in Relapsed/Refractory B-ALL

March 14, 2024 updated by: Zhujiang Hospital
CD19-negative B-ALL relapses after CD19 CAR T-cell treatment have occurred in some patients. CD20/CD22/CD10 is still expressed in CD19 negative B-ALL cells which means these CD molecules may become new targets in treatment of CD19-negative relapse of B-ALL. Thus sequential treatment with CD20/CD22/CD10-CART after CD19-CART treatment in relapsed/refractory B-ALL will kill and eliminate CD19 negative B-ALL cells and prolong the remission time.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

B-cell acute lymphoblastic leukemia is the most common type of leukemia and the prognosis of relapsed/refractory B-ALL is poor. Chimeric Antigen Receptor-transduced T cell (CAR-T) therapy is one of revolutionary targeted immunotherapy. CD19 CAR-T is the most commonly used engineered T cell in B-ALL. The treatment effect is significant and far more than traditional therapy in relapsed/refractory B-ALL. However, the remission time after CD19 CAR-T infusion is short.CD19-positive and CD19-negative B-ALL relapses after CD19 CAR T-cell treatment have occurred in some patients The cause of relapse after CAR-T infusion is minimal residual disease (MRD) which will induce CD19 negative relapse. CD20/CD22/CD10 is still expressed in CD19 negative B-ALL cells which means these CD molecules may become new targets in treatment of CD19 negative relapse of B-ALL. Thus sequential treatment with CD20/CD22/CD10-CART after CD19-CART treatment in relapsed/refractory B-ALL will kill and eliminate CD19 negative B-ALL cells and prolong the remission time.

Study Type

Interventional

Enrollment (Estimated)

100

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 Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangdong, Guangdong, China, 510000
        • Recruiting
        • Southern Medical University Zhujiang Hospital
        • Contact:
          • Yuhua Li, PhD

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Relapsed/Refractory B-ALL patients
  2. Did not achieve complete remission after 2 times of standard plan chemotherapy
  3. Relapsed after first induction chemotherapy
  4. Did not response to chemotherapy before HSCT or relapsed after HSCT
  5. Cannot receive allo-HSCT or refuse to receive allo-HSCT
  6. Cell phenotype is CD19 and CD20/CD22/CD10/CD70 positive (single or combined)
  7. Estimated survival time is more than 3 months in leukemia
  8. Volunteered for this clinical trail and signed a consent form

Exclusion Criteria:

  1. MRD was negative while the cell phenotype was CD19 expressed
  2. Patients with severe insufficient cardiac, pulmonary and hepatorenal functions
  3. Patients with severe mental illness, neurological disease or infectious disease
  4. Patients with GVHD was taking immunosuppressants
  5. Pregnant or lactating women
  6. Patients have received other genetic therapy products
  7. Transfection efficiency was less than 30%
  8. Any situation may do harm to the subjects or interfere the results

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: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequential therapy with different CART
Sequential therapy With different CART including one kind of CD20/CD22/CD10-CART After CD19-CART therapy in CD19-negative relapse ALL patients, subjects will receive 1-5 x 10^6/Kg transduced CAR T cells at one time.
Biological: Sequential Treatment With different CART
Sequential Treatment With CD20/CD22/CD10-CART After CD19-CART Treatment in Relapsed/Refractory B-ALL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events that Are related to treatment
Time Frame: 2 years
Determine the toxicity profile of the CD19-targeted and CD20/CD22/CD10-targeted CAR-T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimate 2 year overall survival(OS) after infusion of CD19-CART and sequential treatment
Time Frame: 2 years
To estimate 2 year overall survival(OS) after CD19-CART infusion and sequential treatment with Relapsed/Refractory B-ALL
2 years
Estimate relapse rate after infusion of CD19-CART and sequential treatment
Time Frame: 4 years
To estimate relapse rate after CD19-CART infusion and sequential treatment with Relapsed/Refractory B-ALL
4 years
Estimate 2 year progression free survival after infusion of CD19-CART and sequential treatment
Time Frame: 2 years
To estimate 2 year progression free survival (PFS) after CD19-CART infusion and sequential treatment with Relapsed/Refractory B-ALL
2 years

Collaborators and Investigators

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

Sponsor

Zhujiang Hospital

Collaborators

Nanfang Hospital, Southern Medical University

Investigators

  • Principal Investigator: Yanjie He, Ph.D, Zhujiang 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)

January 18, 2016

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

April 9, 2017

First Submitted That Met QC Criteria

January 16, 2018

First Posted (Actual)

January 23, 2018

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2016-XYNK-002

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

product manufactured in and exported from the U.S.

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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