Clinical trial · Interventional
Treatment of Relapsed and/or Chemotherapy Refractory B-cell Malignancy by Tandem CAR T Cells Targeting CD19 and CD22
Clinical Study of CD19/CD22 Tan CAR T Cells in Relapsed and/or Chemotherapy Refractory B-cell Leukemias and Lymphomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells. PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in treating patients with B-cell leukemia or lymphoma that is relapsed (after stem cell transplantation or intensive chemotherapy) or refractory to chemotherapy.
Conditions
Conditions (23)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Acute Lymphoblastic Leukemia in Remission | Adult Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| B-cell Adult Acute Lymphoblastic Leukemia | Adult B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| B-Cell Chronic Lymphocytic Leukemia in Relapse (Diagnosis) | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
| Hematopoietic/Lymphoid Cancer | — | UNRESOLVED | — |
| Prolymphocytic Leukemia | Prolymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Recurrent Adult Diffuse Large Cell Lymphoma | — | UNRESOLVED | — |
| Recurrent Grade 1 Follicular Lymphoma | Grade 1 Follicular Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Grade 2 Follicular Lymphoma | Grade 2 Follicular Lymphoma | CURATED_BROADER |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-CD19/22-CAR vector-transduced T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- anti-CD19/22 CAR T cells
- description
- Patients receive anti-CD19/22-CAR retroviral vector-transduced autologous or donor-derived T cells on days 0,1, 2 in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: anti-CD19/22-CAR vector-transduced T cells
Primary outcomes (1)
- measure
- Occurrence of study related adverse events
- timeFrame
- Until week 24
- description
- defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
Secondary outcomes (1)
- measure
- Anti-tumor responses to tanCART19/22 cell infusions
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female subjects with CD19/22+ B cell malignancies in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to \< 2 year survival) with currently available therapies will be enrolled CD19/22+ leukemia or lymphoma ALL in CR2(second complete remission) or CR3(third complete remission) and not eligible for allogeneic SCT because of age, comorbid disease, or lack of available family member or unrelated donor Follicular lymphoma, previously identified as CD19/22+: At least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody (Rituxan) therapy Stage III-IV disease Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval \< 1 year) Disease responding or stable after most recent therapy (chemotherapy, MoAb, etc) CLL: At least 2 prior chemotherapy regimens (not including single agent monoclonal antibody (Rituxan) therapy. Patients with high risk disease manifested by deletion chromosome 17p will be eligible if they fail to achieve a CR to initial therapy or progress within 2 years of 1 prior Less than 2 years between last chemotherapy and progression (i.e. most recent progression free interval \< 2 years) Not eligible or appropriate for conventional allogeneic SCT Patients who achieve only a partial response to FCR(fludarabine, cyclophosphamide and Rituxan) as initial therapy will be eligible. Mantle cell lymphoma: Beyond 1st CR (complete remission) with relapsed or persistent disease and not eligible or appropriate for conventional allogeneic or autologous SCT Disease responding or stable after most recent therapy (chemotherapy, MoAb, etc...) Relapsed after prior autologous SCT B-cell prolymphocytic leukemia (PLL) with relapsed or residual disease after at least 1 prior therapy and not eligible for allogeneic SCT Diffuse large cell lymphoma, previously identified as CD19+: Residual disease after primary therapy and not eligible for autologous SCT Relapsed after prior autologous SCT Beyond 1st CR with relapsed or persistent disease and not eligible or appropriate of conventional allogeneic or autologous SCT Expected survival \> 12 weeks Creatinine \< 2.5 mg/dl ALT(alanine aminotransferase)/AST (aspartate aminotransferase)\< 3x normal Bilirubin \< 2.0 mg/dl Any relapse after prior autologous SCT will make patient eligible regardless of other prior therapy Adequate venous access for apheresis, and no other contraindications for leukapheresis Voluntary informed consent is given Exclusion Criteria: * Pregnant or lactating women The safety of this therapy on unborn children is not known Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion Uncontrolled active infection Active hepatitis B or hepatitis C infection Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary Previously treatment with any gene therapy products Feasibility assessment during screening demonstrates \< 30% transduction of target lymphocytes, or insufficient expansion (\< 5-fold) in response to CD3/CD137 costimulation Any uncontrolled active medical disorder that would preclude participation as outlined HIV infection
References
Publications (1)
- DERIVEDDai H, Wu Z, Jia H, Tong C, Guo Y, Ti D, Han X, Liu Y, Zhang W, Wang C, Zhang Y, Chen M, Yang Q, Wang Y, Han W. Bispecific CAR-T cells targeting both CD19 and CD22 for therapy of adults with relapsed or refractory B cell acute lymphoblastic leukemia. J Hematol Oncol. 2020 Apr 3;13(1):30. doi: 10.1186/s13045-020-00856-8. PMID 32245502