CAR-T cell therapy for relapsed B cell leukemia and lymphoma
Safety and Efficacy of CAR2219 CAR-T Cells in Treatment of Relapsed/refractory CD19/CD22 Positive B Cell Leukemia and Lymphoma
This study is testing a new CAR-T cell therapy to see if it can help people with relapsed B cell leukemia and lymphoma feel better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 14 Years to 75 Years |
| Sex | All |
| Sponsor | Affiliated Hospital to Academy of Military Medical Sciences Academic / other |
| Drugs / interventions | rituximab, CAR-T, chemotherapy, CAR T |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06834529 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of CAR2219 CAR-T cells in patients with relapsed or refractory CD19/CD22 positive B cell leukemia and lymphoma. It is a single-arm, open-label study that will enroll 20 subjects who will receive CAR2219 CAR-T cell injections. Participants will be monitored for adverse reactions and therapeutic effects following treatment. The goal is to gather data on the treatment's effectiveness and safety profile.
Who should consider this trial
Good fit: Ideal candidates are individuals with relapsed or refractory CD19/CD22 positive B cell leukemia or lymphoma.
Not a fit: Patients who do not have CD19/CD22 positive B cell malignancies or those with other types of leukemia or lymphoma 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 leukemia and lymphoma.
How similar studies have performed: Other studies using CAR-T cell therapies have shown promising results, indicating that this approach has potential based on previous successes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Signed written informed consent; 2. Relapsed/refractory CD19/CD22 positive B cell Leukemia or Lymphoma must be assured and meet one of the following conditions: (1) Confirmation for either CD19 or CD22 positivity using immunohistochemistry or flow cytometry; (2) B-cell tumors include the following three categories: ① B-cell acute lymphoblastic leukemia (B-ALL); Indolent B-cell lymphoma (CLL, FL, MZL, LPL, HCL); Aggressive B-cell lymphoma (DLBCL, BL, MCL) (3) Refractory/recurrent B-ALL (include one of the following situations) : ① relapse within 12 months after the first remission; ② The first refractory patients who did not achieve complete remission after 2 cycles of standard chemotherapy regimen; ③ Failure to achieve complete remission or relapse after first-line or multi-line salvage chemotherapy; ④ Recurrence after hematopoietic stem cell transplantation. (4) Refractory/recurrent B-cell lymphoma (meeting the requirements of 1 of the first 4 below plus 5) : ① After 4 courses of chemotherapy prescribed by the standard protocol, the tumor has shrunk by less than 50% or the disease progression(PD); ② CR reached after standard chemotherapy, but relapse occurred within 12 months; ③ Two or more recurrence after CR; ④ Recurrence after hematopoietic stem cell transplantation; ⑤Patients must have received rituximab or another anti-CD20 monoclonal antibody (unless Investigator determines that tumor is CD20-negative) and an anthracycline-containing chemotherapy regimen. 3. All genders, ages: 14 to 75 years 4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2. 5. Life expectancy ≥3 months; 6. HGB≥70g/L 7. Liver,kidney function and cardiopulmonary function meet the following requirements: (1) creatinine ≤1.5×ULN; (2) left ventricular ejection fraction≥50%; (3) Oxygen saturation \>90%; (4) Total bilirubin ≤1.5×ULN, ALT and AST≤2.5×ULN; 8. Participants agreed to use contraception from the time of informed consent until 1 year after CAR-T cell infusion." Exclusion Criteria: 1. Severe heart failure with left ventricular ejection fraction \<50%; 2. A history of severe lung function impairment; 3. Combined with other advanced malignant tumors; 4. Complicated with severe infection that could not be effectively controlled; 5. Severe autoimmune disease or congenital immune deficiency; 6. Active hepatitis (hepatitis B virus DNA \[HBV-DNA\] or hepatitis C virus RNA \[HCV-RNA\] test results above the lower limit of detection); 7. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection; 8. History of severe allergy to biological products (including antibiotics); 9. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) patients with acute graft-versus-host reaction (GVHD) one month after immunosuppressant withdrawal; 10. Patients with other serious physical or mental illnesses or laboratory abnormalities that could increase the risk of participating in the study or interfere with the results of the study, and those who were deemed by the investigator to be unsuitable for participation in the study.
Where this trial is running
Beijing, Beijing Municipality
- the Fifth Medical Center of Chinese People's Liberation Army General Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Hongmei Ning, Dr
- Email: ninghongmei72@sina.com
- Phone: +86 01066947164
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.