Sequential treatment for relapsed B-ALL using targeted CAR T-cells
Sequential Treatment With CD20/CD22/CD10-CART After CD19-CART Treatment Base on MRD in Relapsed/Refractory B-ALL
This study is testing a new treatment for patients with relapsed B-cell leukemia to see if using different CAR T-cell therapies can help them stay in remission longer.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Zhujiang Hospital Academic / other |
| Drugs / interventions | chemotherapy, CAR T, CART, CAR-T, Chimeric Antigen Receptor, immunotherapy |
| Locations | 1 site (Guangdong, Guangdong) |
| Trial ID | NCT03407859 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a sequential treatment approach for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) who have not achieved complete remission after standard chemotherapy. The study utilizes a combination of CAR T-cell therapies targeting CD20, CD22, and CD10 after initial treatment with CD19 CAR T-cells. The goal is to eliminate CD19-negative B-ALL cells that may cause relapse and to prolong remission times. The trial focuses on patients with specific cell phenotypes and aims to improve outcomes for those who have limited treatment options.
Who should consider this trial
Good fit: Ideal candidates include patients with relapsed or refractory B-ALL who have not responded to standard chemotherapy and have specific CD antigen expressions.
Not a fit: Patients with CD19-positive minimal residual disease or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly extend remission periods for patients with relapsed B-ALL.
How similar studies have performed: While CAR T-cell therapies have shown promise in treating B-ALL, this specific sequential approach targeting multiple antigens is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Relapsed/Refractory B-ALL patients 2. Did not achieve complete remission after 2 times of standard plan chemotherapy 3. Relapsed after first induction chemotherapy 4. Did not response to chemotherapy before HSCT or relapsed after HSCT 5. Cannot receive allo-HSCT or refuse to receive allo-HSCT 6. Cell phenotype is CD19 and CD20/CD22/CD10/CD70 positive (single or combined) 7. Estimated survival time is more than 3 months in leukemia 8. Volunteered for this clinical trail and signed a consent form Exclusion Criteria: 1. MRD was negative while the cell phenotype was CD19 expressed 2. Patients with severe insufficient cardiac, pulmonary and hepatorenal functions 3. Patients with severe mental illness, neurological disease or infectious disease 4. Patients with GVHD was taking immunosuppressants 5. Pregnant or lactating women 6. Patients have received other genetic therapy products 7. Transfection efficiency was less than 30% 8. Any situation may do harm to the subjects or interfere the results
Where this trial is running
Guangdong, Guangdong
- Southern Medical University Zhujiang Hospital — Guangdong, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Yanjie He, Ph.D — Zhujiang Hospital
- Study coordinator: Yuhua Li, Ph.D
- Email: liyuhua2011gz@163.com
- Phone: 86-20-61643188
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.