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Donor Derived CD19 CAR-T Cells in the Treatment of R/R B-cell Acute Lymphoblastic Leukemia

A Clinical Study on the Safety and Effectiveness of Donor Derived CD19 CAR-T Cells in the Treatment of R/R B-cell Acute Lymphoblastic Leukemia

NCT06793241•Zhejiang University

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Summary

A Clinical Study on the Safety and Effectiveness of donor derived CD19 CAR-T Cells in the treatment of R/R B-cell acute lymphoblastic leukemia

Detailed Description

In this study, 15 patients with relapsed refractory B-cell acute lymphoblastic leukemia were proposed to undergo CD19 CAR-T Cells therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD19 CAR-T Cells therapy for relapsed refractory B-cell acute lymphoblastic leukemia; At the same time, on the basis of expanding the sample size, more safety data on CD19 CAR-T Cells treatment for relapsed refractory B-cell acute lymphoblastic leukemia were accumulated.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Age ≥18 years old, gender unlimited;
•2\. Abnormal B cell immunotyping was CD19 positive;
•3\. Patients diagnosed with B-cell acute lymphoblastic leukemia by histological or immunotyping;
•4\. Meets the diagnosis of relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) and includes any of the following conditions:
•1. No CR was obtained after standard chemotherapy;
•2. CR was induced for the first time, but the duration of CR was less than 12 months;
•3. R/R B-ALL that does not work after the first or more remedial treatments;
•4. Two or more relapses;
•5\. The researchers believed that the patient had been adequately treated, such as auto-HSCT, auto-CART could not be prepared or preparation failed. Autologous CAR-T preparation failure was defined as including too few autologous lymphocytes (\<1×109) or insufficient expansion during preparation or failure to meet the release criteria;
•6\. Total bilirubin ≤51 ( μmol/L), alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal, creatinine ≤176.8 (μmol/L);
+6 more criteria

Exclusion Criteria

•1\. Known allergies to research preconditioning measures, etc;
•2\. People with a history of epilepsy or other central nervous system disorders;
•3\. People with a history of prolonged QT or severe heart disease;
•4\. Less than 100 days after receiving allogeneic hematopoietic stem cell transplantation;
•5\. Hiv-infected person;
•6\. Persons with active hepatitis B or C virus; Those who are not cured have active infections;
•7\. Insufficient amplification ability (\< 5x) in response to CD3 / CD28 costimulatory signals;
•8\. Combined use of systemic steroids (e.g., prednisone ≥20mg) within 3 days prior to screening, except for ongoing or intermittent use of topical, inhaled or intranasal steroids within 2 weeks or at present; Or have systemic diseases that require long-term use of immunological agents;
•9\. Patients who received anti-cancer chemotherapy or other drugs within 2 weeks prior to screening;
•10\. Any situation that the investigator believes may increase the risk of the subjects or interfere with the study results.

Locations (1)

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, China

Key Dates

Start Date

January 31, 2025

Primary Completion Date

January 31, 2028

Completion Date

January 31, 2028

Last Updated

January 27, 2025

Enrollment

ESTIMATED participants

Conditions

B-cell Acute Lymphoblastic Leukemia

Interventions

CD19 B-cell Acute Lymphoblastic Leukemia Targeted CAR T-cells injection

BIOLOGICAL

Contacts

He Huang, MD

CONTACT

0571-87233772 hehuangyu@126.com

Yongxian Hu, MD

CONTACT

0571-87233772 huyongxian2000@aliyun.com

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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: January 27, 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.

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Donor Derived CD19 CAR-T Cells in the Treatment of R/R B-cell Acute Lymphoblastic Leukemia

Inclusion Criteria

Exclusion Criteria

Clinical Study of SYNCAR-100 in the Treatment of Relapsed/Refractory Acute B-Lymphoblastic Leukemia

Long-term Follow up Local Registry Study of Kymriah in South Korea

Study of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone for Relapsed B-cell ALL

A Study of Fludarabine Dosing in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia

CD22/CD19 CAR-T and Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL

CART19 Cells Effects in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma