RecruitingEarly Phase 1NCT06659653

Safety and Efficacy of PRG-2302 for Refractory or Relapsed B-cell Acute Lymphoblastic Leukemia Disease.

Safety and Effectiveness of PRG2302 (CD19/CD22-targeting CAR-T Cells) for Refractory or Relapsed B-cell Acute Lymphoblastic Leukemia Disease.


Sponsor

Tan Jie

Enrollment

18 participants

Start Date

May 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

A Clinical Study on the Safety and Effectiveness of CD19/CD22 Chimeric Antigen Receptor T Cells in the Treatment of Refractory or Relapsed B-cell Acute Lymphoblastic Leukemia Disease.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new treatment called PRG-2302 — a type of engineered immune cell therapy — for adults with B-cell acute lymphoblastic leukemia (B-ALL), a blood cancer, that has come back or stopped responding to standard treatments. **You may be eligible if...** - You are between 18 and 70 years old - You have confirmed B-cell ALL that has relapsed (come back) or is refractory (did not respond to treatment) - Your bone marrow or blood shows the cancer cells are still present - Your heart, kidneys, and liver are functioning adequately - Your expected survival is at least 3 months **You may NOT be eligible if...** - You have active uncontrolled infection - You have other serious conditions affecting your organ function - You have certain other blood cancers in addition to B-ALL - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPRG2302

Dose group 1: with a dosage of 0.5x10\^6 (cells/kg) per dose Dose group 2: with a dosage of 1.0x10\^6 (cells/kg) per dose Dose group 3: with a dosage of 2.0x10\^6 (cells/kg) per dose


Locations(1)

The First People's Hospital of Jingzhou

Jinzhou, Hubei, China

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NCT06659653


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