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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age14-75
SponsorAffiliated Hospital to Academy of Military Medical Sciences

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • CAR2219-T cells

Treatment groups

20 Participants
are divided into 1 treatment group