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a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B-ALL | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B-ALL

Study Evaluating Safety and Efficacy of CD19 and CD22 Targeted Prime CAR-T Cell in Patients With Relapsed/Refractory B-ALL

NCT04781634•Chongqing Precision Biotech Co., Ltd

View on ClinicalTrials.gov

Summary

This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cells therapy for patients with relapsed/refractory B -ALL

Detailed Description

Although the anti-CD19 CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell hematologic malignancies. There are patients who resisted anti-CD19 CAR-T cells or with CD19 negative relapse. To make further improvement, the investigators launch such a clinical trial using CD19 and CD22 targeted prime CAR-T cells for patients with relapsed and refractory B-ALL to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cell therapy.

Eligibility

Age

2 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed written informed consent
•2. Diagnose as Relapsed and Refractory B -ALL, and meet one of the following conditions:
•1. Failed to standard chemotherapy regimens;
•2. Relapse after complete remission, high-risk and / or refractory patients ;
•3. Relapse after hematopoietic stem cell transplantation;
•3. For patients with Ph + ALL, the following conditions must be met: those who have received a standard induction chemotherapy regimen and who have not achieved complete remission after TKI treatment or have relapsed after remission (cannot tolerate TKI treatment or have contraindications to TKI treatment or the presence of TKI class) Except for drug resistant patients)
•4. Evidence for cell membrane CD19 or CD22 expression
•5. All genders ages: 2 to 75 years
•6. The expect time of survive is above 3 months;
•7. KPS\>60
+7 more criteria

Exclusion Criteria

•1. Previous history of other malignancy;
•2. Presence of uncontrolled active infection;
•3. Evidence of disorder that need the treatment by glucocorticoids;
•4. Active or chronic GVHD
•5. The patients treatment by inhibitor of T cell
•6. Pregnant or breasting-feeding women;
•7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.

Locations (1)

920th Hospital of Joint Logistics Support Force

Kunming, Yunnan, China

Key Dates

Start Date

March 7, 2021

Primary Completion Date

December 31, 2026

Completion Date

July 1, 2027

Last Updated

February 25, 2025

Enrollment

ESTIMATED participants

Conditions

B-ALL

Interventions

CD19 and CD22 targeted prime CAR-T cells

BIOLOGICAL

Contacts

Zhi Yang, PhD

CONTACT

86-13206140093 yangzhi@precision-biotech.com

Sanbin Wang, MD

CONTACT

Sanbin1011@163.com

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies

NCT05442515

B-NHLB-Non Hodgkin Lymphoma+9 more

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RECRUITINGPHASE2

Orphan Indications for CD19 Redirected Autologous T Cells

NCT04276870

Pediatric and Young Adult Patientswith Hypodiploid or t(17;19) B-ALLInfants With Very High Risk KMT2A B-ALL+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B-ALL

Inclusion Criteria

Exclusion Criteria

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies

Orphan Indications for CD19 Redirected Autologous T Cells

JY231(JY231) Injection for the Treatment of Relapsed or Refractory B Cell Lymphoma/ Leukemia

Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies

Anti-CD22 Chimeric Receptor T Cells in Pediatric and Young Adults With Recurrent or Refractory CD22-expressing B Cell Malignancies

Blinatumomab as Maintenance Therapy in Patients With High-risk B-lineage Acute Lymphoblastic Leukemia Post Allogeneic Hematopoietic Cell Transplantation