Clinical trial · Interventional
CART-19 Immunotherapy in Mantle Cell Lymphoma
Anti-CD19 Chimeric Antigen Receptor Modified T Cells Infusion in Mantle Cell Lymphoma
NCT02081937CI-TRIAL-00013995unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Patients receive anti-CD19-CAR (coupled with CD137 and CD3 zeta signalling domains)vector-transduced autologous T cells over a period of 4 or 5 consecutive days in an escalating dose. After completion of study treatment, patients are followed intensively for 6 months, every 3 months for 2 years, and annually thereafter for 10 years.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic/Lymphoid Cancer | Hematopoietic and Lymphoid Cell Neoplasm | PROBABILISTIC | 0.70 |
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Non-hodgkin Lymphoma,B Cell | B-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
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 d1-5 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 2 years
- description
- defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to the study.
Secondary outcomes (1)
- measure
- Clinical responses to CART-19 cell therapy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female with CD19+ relapsed or refractory MCL, and 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. * 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. * 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 * 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 (0)
Data not yet available
No reference posted for this study.