Humanized CD19 CAR-T cell therapy for relapsed B-cell leukemia and lymphoma
Clinical Trial for the Safety and Efficacy of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma
This study is testing a new type of CAR-T cell therapy to see if it can help people with relapsed B-cell leukemia and lymphoma feel better and improve their chances of recovery.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 3 Years to 75 Years |
| Sex | All |
| Sponsor | Zhejiang University Academic / other |
| Drugs / interventions | CAR-T, chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT04532268 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of humanized CD19 CAR-T cell therapy in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin's lymphoma (B-NHL). It is a single-arm, open-label, single-center trial that will enroll two groups of patients, with a total of 72 participants. The study aims to determine the appropriate dose levels and assess dose-related safety based on previous clinical trials of similar therapies.
Who should consider this trial
Good fit: Ideal candidates include males and females aged 3-70 with relapsed or refractory CD19+ B-ALL or males and females aged 18-75 with relapsed or refractory B-NHL.
Not a fit: Patients with CD19-negative malignancies or those who are not relapsed or refractory may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat B-cell malignancies.
How similar studies have performed: Previous studies of CAR-T cell therapies have shown promising results in treating similar hematological malignancies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Inclusion criteria only for B-ALL:
1. Male or female aged 3-70 years;
2. Histologically confirmed diagnosis of CD19+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);
3. Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):
1. CR not achieved after standardized chemotherapy;
2. CR achieved following the first induction, but CR duration is less than 12 months;
3. Ineffectively after first or multiple remedial treatments;
4. 2 or more relapses;
4. The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is \>5% (by morphology), and/or \>1% (by flow cytometry);
5. Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;
* Inclusion criteria only for B-NHL:
1. Male or female aged 18-75 years;
2. Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL/SLL, PMBCL, and HGBCL per the WHO Classification Criteria for Lymphoma (2016);
3. Relapsed or refractory B-NHL (meeting one of the following conditions):
1. No response or relapse after second-line or above chemotherapy regimens;
2. Primary drug resistance;
3. Relapse after auto-HSCT;
4. At least one assessable tumor lesion per Lugano 2014 criteria;
* Common inclusion criteria for B-ALL and B-NHL:
1. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
2. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
3. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
4. Estimated survival time ≥ 3 months;
5. ECOG performance status 0 to 2;
6. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.
Exclusion Criteria:
Subjects with any of the following exclusion criteria were not eligible for this trial:
1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
3. Pregnant (or lactating) women;
4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
5. Active infection of hepatitis B virus or hepatitis C virus;
6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids;
7. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
8. Creatinine \>2.5mg/dl, or ALT / AST\>3 times of normal amounts, or bilirubin\>2.0 mg/dl;
9. Other uncontrolled diseases that were not suitable for this trial;
10. Patients with HIV infection;
11. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Where this trial is running
Hangzhou, Zhejiang
- The First Affiliated Hospital，College of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: He Huang, PhD
- Email: hehuangyu@126.com
- Phone: 86-13605714822
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.