CAR2219 CAR-T Cells for the Treatment of R/R B Cell Leukemia and Lymphoma

Launched by AFFILIATED HOSPITAL TO ACADEMY OF MILITARY MEDICAL SCIENCES · Feb 13, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called CAR2219 CAR-T cells for patients with certain types of B cell leukemia and lymphoma that have not responded to other treatments. The goal is to see if this therapy is safe and effective for people whose cancer has come back or has not improved with standard treatments. The trial is currently looking for participants, specifically individuals aged 14 to 75 who have been diagnosed with relapsed or refractory B cell leukemia or lymphoma that is positive for CD19 or CD22 proteins.

To join the trial, participants must provide informed consent and meet specific health criteria, such as having a life expectancy of at least three months and stable organ function. Those who have severe heart or lung problems, certain infections, or other serious health issues may not be eligible. If selected, participants will receive CAR-T cell therapy and will be monitored closely for any side effects and how well the treatment is working. This trial offers hope for patients who have limited options left, and involvement could contribute to important research in cancer treatment.

Gender

ALL

Eligibility 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.