Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
ID06793241

Study of Donor Derived CD19 CAR-T Cell Therapy for Relapsed Refractory B-cell Acute Lymphoblastic Leukemia Evaluating Safety and Effectiveness

Led by Zhejiang University · Updated on 2025-01-27

15

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

Z

Zhejiang University

Lead Sponsor

Y

Yake Biotechnology Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of donor-derived CD19 CAR-T cells in treating relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL). This early-phase clinical study aims to expand the sample size to gather more safety data while further assessing the treatment's effectiveness in patients who have not responded well to standard therapies or have relapsed multiple times. Participants receive CD19-targeted CAR-T cells through intravenous infusion. The treatment focuses on patients whose leukemic B cells express the CD19 marker and who have either failed standard chemotherapy or other treatments, including autologous CAR-T preparation. The study builds on previous safety data and continues to monitor participants closely. During the study, patients undergo various assessments including monitoring for dose-limiting toxicity within 28 days after treatment and tracking treatment-emergent adverse events for up to two years. Researchers evaluate clinical responses, laboratory tests, and heart function. Participants must provide informed consent and agree to use contraception if fertile. The study involves continuous safety monitoring over an extended period to understand both short-term and long-term effects.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older, any gender
  • CD19 positive abnormal B cell immunotyping
  • Diagnosed with B-cell acute lymphoblastic leukemia by histology or immunotyping
  • Relapsed or refractory B-cell acute lymphoblastic leukemia, including no complete remission after standard chemotherapy, remission less than 12 months, failure after remedial treatments, or two or more relapses
  • Inadequate response or failure to prepare autologous CAR-T cells
  • Total bilirubin ≤ 51 μmol/L; ALT/AST ≤ 3 times upper limit of normal; creatinine ≤ 176.8 μmol/L
  • Absolute neutrophil count ≥ 0.5×10⁹/L; Platelet count ≥ 30×10⁹/L; Hemoglobin ≥ 60 g/L
  • Left ventricular ejection fraction (LVEF) ≥ 40% by echocardiography
  • Estimated survival more than 3 months
  • ECOG performance status score between 0 and 2
  • Fertile women and men must agree to use contraception during and for 6 months after the study
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Known allergies to preconditioning treatments
  • History of epilepsy or other central nervous system disorders
  • History of prolonged QT interval or severe heart disease
  • Less than 100 days since allogeneic hematopoietic stem cell transplantation
  • HIV infection
  • Active hepatitis B or C infection that is not cured
  • Insufficient T cell amplification in response to CD3/CD28 stimulation
  • Use of systemic steroids (e.g., prednisone ≥ 20 mg) within 3 days prior to screening, except ongoing or intermittent topical, inhaled, or intranasal steroids
  • Systemic diseases requiring long-term immunosuppressive agents
  • Anti-cancer chemotherapy or other drugs received within 2 weeks prior to screening
  • Any condition increasing risk or interfering with study results as judged by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, China, 310003

Actively Recruiting

Loading map...

Research Team

H

He Huang, MD

Y

Yongxian Hu, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here