Clinical trial · Interventional
Treatment of Relapsed and/or Chemotherapy Refractory B-cell Malignancy by CART19
Clinical Study of Chimeric CD(Cluster of Differentiation)19 Antigen Receptor-modified 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 | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| 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 | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-CD19-CAR vector-transduced T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- anti-CD19 CAR T cells
- description
- Patients receive anti-CD19-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-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 CART-19 cell infusions
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female subjects with CD19+ 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+ 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+: * 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 (2)
- DERIVEDZhang WY, Liu Y, Wang Y, Nie J, Guo YL, Wang CM, Dai HR, Yang QM, Wu ZQ, Han WD. Excessive activated T-cell proliferation after anti-CD19 CAR T-cell therapy. Gene Ther. 2018 Jun;25(3):198-204. doi: 10.1038/s41434-017-0001-8. Epub 2018 Mar 29. PMID 29599530
- DERIVEDDai H, Zhang W, Li X, Han Q, Guo Y, Zhang Y, Wang Y, Wang C, Shi F, Zhang Y, Chen M, Feng K, Wang Q, Zhu H, Fu X, Li S, Han W. Tolerance and efficacy of autologous or donor-derived T cells expressing CD19 chimeric antigen receptors in adult B-ALL with extramedullary leukemia. Oncoimmunology. 2015 May 26;4(11):e1027469. doi: 10.1080/2162402X.2015.1027469. eCollection 2015 Nov. PMID 26451310