RecruitingPhase 1/2

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

China20 participantsStarted 2025-01-20

Plain-language 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.

Who can participate

Age range14 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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."

Exclusion criteria

✕. 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);

What they're measuring

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.

Timeframe: 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.

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

Trial details

NCT IDNCT06834529

SponsorAffiliated Hospital to Academy of Military Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-31

Contact for this trial

Hongmei Ning, Dr

+86 01066947164 ninghongmei72@sina.com

View on ClinicalTrials.gov More Relapsed or Refractory B Cell Leukemia and Lymphoma trials