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

NCT ID: NCT06834529

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-20
• Study Completion Date: 2027-01-31

Brief Summary

This is a single arm study to evaluate the safety and efficacy of CAR2219 CAR-T cells in the treatment of relapsed/refractory CD19/CD22 positive B cell Leukemia and Lymphoma.

Detailed Description

This study is an exploratory clinical trial of a single-arm, open, single-center treatment of CAR2219 CAR-T cell. 20 subjects with relapsed or refractory CD19/ CD22 positive B-cell Leukemia and Lymphoma will be enrolled and received CAR2219 CAR T cells injection therapy, and related data such as adverse reactions and therapeutic effects after medication were followed up. To evaluate its safety and efficacy.

Conditions

Relapsed or Refractory B Cell Leukemia and Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

This is a single arm treatment of CAR2219 CAR-T cell.

Experimental: CAR2219-T cells Therapy Investigational product: CAR2219-T cells Route of administration: Intravenous injection Lymphodepleting chemotherapy regimen: A combination of fludarabine and cyclophosphamide will be administered prior to the infusion of CD2219-CAR-T cells.

Interventions: Biological: Autologous or donor's anti-CD19 and anti-CD22 dual specific CAR-T Cells Drug: Fludarabine and Cyclophosphamide.

Group Type: EXPERIMENTAL

CAR2219-T cells

Intervention Type: GENETIC

Genetic: CAR2219-T cells Each subject will be infused with single dose of CD2219-CAR-T cells. A classic "3+3" dose escalation will be employed. The low dose is 5×10^5 /kg, the medium dose is 1×10^6 /kg, and the high dose is 2×10^6 /kg.

Drug: Fludarabine Fludarabine will be given at a dose of 30 mg/m2/day intravenously (IV) for 3 days prior to the infusion of CD2219-CAR-T cells.

Drug: Cyclophosphamide Cyclophosphamide will be given at a dose of 300 mg/m2/day intravenously (IV) for 3 days prior to the infusion of CD2219-CAR-T cells.

Interventions

CAR2219-T cells

Genetic: CAR2219-T cells Each subject will be infused with single dose of CD2219-CAR-T cells. A classic "3+3" dose escalation will be employed. The low dose is 5×10^5 /kg, the medium dose is 1×10^6 /kg, and the high dose is 2×10^6 /kg.

Drug: Fludarabine Fludarabine will be given at a dose of 30 mg/m2/day intravenously (IV) for 3 days prior to the infusion of CD2219-CAR-T cells.

Drug: Cyclophosphamide Cyclophosphamide will be given at a dose of 300 mg/m2/day intravenously (IV) for 3 days prior to the infusion of CD2219-CAR-T cells.

Intervention Type: GENETIC

Other Intervention Names

Fludarabine; Cyclophosphamide

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital to Academy of Military Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

the Fifth Medical Center of Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongmei Ning, Dr

Role: CONTACT

ninghongmei72@sina.com

+86 01066947164

Facility Contacts

Ethics Committee

Role: primary

ec307yy@163.com

010-66947798

Other Identifiers

CAR2219-XYBYXB

Identifier Type: -

Identifier Source: org_study_id