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

NCT06834529 | Recruiting Phase 1 DMC

• 1 other identifier: CAR2219-XYBYXB
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsed or Refractory B Cell Leukemia and Lymphoma

Keywords

CAR-T; B cell Leukemia; B cell Lymphoma; CD19/CD22

Outcome Measures

Primary Outcomes (2)

• According to the incidence of treatment-related adverse events (AEs) to evaluate the safetyof CAR2219 CAR-T cells in the treatment of relapsed/refractory CD19+CD22+ B-cell Leukemia and Lymphoma.

  Incidence of treatment-related adverse events (AEs) Description: Number and severity of adverse events graded according to CTCAE v5.0, including cytokine release syndrome (CRS) graded by ASTCT criteria and immune effector cell-associated neurotoxicity syndrome (ICANS) graded by ASBMT criteria

  up to 2 years

• According to the determine the Maximal Tolerable Dose(MTD) to evaluate the safetyof CAR2219 CAR-T cells in the treatment of relapsed/refractory CD19+CD22+ B-cell Leukemia and Lymphoma.

  MTD will be determined based on DLTs observed during the first 28 days of study treatment.

Secondary Outcomes (1)

• According to the objective response rate (ORR) to evaluate the efficacy of CAR2219 CAR-T cells in the treatment of relapsed/refractory CD19+CD22+ B-cell Leukemia and Lymphoma.

  Within 3 months following infusion of CAR2219 CAR-T cells

Other Outcomes (2)

• CAR-T cell expansion kinetics

  Up to 12 months after CAR-T treatment

• CAR-T cell clonality dynamics

  Up to 24 months after CAR-T treatment

Study Arms (1)

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

EXPERIMENTAL

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.

Genetic: CAR2219-T cells

Interventions

CAR2219-T cells 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.

Also known as: Fludarabine, Cyclophosphamide

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

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent;
• 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.
• All genders, ages: 14 to 75 years
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2.
• Life expectancy ≥3 months;
• HGB≥70g/L
• 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;
• Participants agreed to use contraception from the time of informed consent until 1 year after CAR-T cell infusion."

You may not qualify if:

• Severe heart failure with left ventricular ejection fraction \<50%;
• A history of severe lung function impairment;
• Combined with other advanced malignant tumors;
• Complicated with severe infection that could not be effectively controlled;
• Severe autoimmune disease or congenital immune deficiency;
• Active hepatitis (hepatitis B virus DNA \[HBV-DNA\] or hepatitis C virus RNA \[HCV-RNA\] test results above the lower limit of detection);
• Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
• History of severe allergy to biological products (including antibiotics);
• Allogeneic hematopoietic stem cell transplantation (allo-HSCT) patients with acute graft-versus-host reaction (GVHD) one month after immunosuppressant withdrawal;
• 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.

Sponsors & Collaborators

• Affiliated Hospital to Academy of Military Medical Sciences: lead

Study Sites (1)

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

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Leukemia, B-Cell; Lymphoma; Lymphoma, B-Cell

Interventions

fludarabine; Cyclophosphamide

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

Hongmei Ning, Dr

CONTACT

+86 01066947164; ninghongmei72@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: February 19, 2025
• Study Start: January 20, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: February 19, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)