Clinical trial · Interventional
Anti-CD19 CAR T Infusion Combined With Allogeneic Stem Cell Transplantation for B-cell Leukemia/Lymphoma
A Phase I Study of Administrating CD19 Chimeric Antigen Receptor Expressing T Cells Followed by Allogeneic Stem Cell Transplantation in Patients With Refractory CD19+ B-linage Leukemia/Lymphoma
NCT03110640CI-TRIAL-00041963unknownPhase 1ClinicalTrials.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)
This is a single-arm open-label phase I study to determine the effect of CD19- CAR-T Cells infusion followed by allogeneic stem cell transplantation in safety, efficacy and engraftment potential in patients with CD19+ B-lineage leukemia and lymphoma.
Conditions
Conditions (5)
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 | — |
| Refractory Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-CD19 CAR-T | Biological | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD9CAR-T transfer
- description
- All subjects will receive allogeneic stem cell transplantation after infusion of αCD19-TCRz-CD28 CAR-T
- interventionNames
- Biological: anti-CD19 CAR-T
- Drug: Fludarabine
- Drug: Cyclophosphamide
Primary outcomes (1)
- measure
- Safety - incidence of adverse events defined as dose-limited toxicity
- timeFrame
- 180 days
- description
- incidence of adverse events defined as dose-limited toxicity
Secondary outcomes (2)
- measure
- Overall complete remission rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 5 Years to 70 Years, Male and female; * Expected survival \> 12 weeks; * Performance score 0-2; * Histologically confirmed as CD19-positive lymphoma/leukemia and who meet one of the following conditions; Patient receive at least 2-4 prior combination chemotherapy regimens (not including single agent monoclonal antibody therapy) and fail to achieve CR; or have disease recurrence; or not eligible for allogeneic stem cell transplantation; or disease responding or stable after most recent therapy but refused further treatment; Disease recurrence after stem cell transplantation; Diagnosis as lymphoma, but refuse conventional treatment such as chemotherapy, radiation, stem cell transplantation and monoclonal antibody therapy * Creatinine \< 2.5 mg/dl; * ALT/AST \< 3x normal; * Bilirubin \< 2.0 mg/dl; * Adequate venous access for apheresis, and no other contraindications for leukapheresis; * Take contraceptive measures before recruit to this trial; * Written voluntary informed consent is given. Exclusion Criteria: * Patients with symptoms of central nervous system * Accompanied by other malignant tumor * Active hepatitis B or C, HIV infection * Any other diseases could affect the outcome of this trial * Suffering severe cardiovascular or respiratory disease * Poorly controlled hypertension * A history of mental illness and poorly controlled * Taking immunosuppressive agents within 1 week due to organ transplantation or other disease which need long-lasting administration * Occurrence of unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events 30 days prior to assignment * Reaching a steady dose if receiving anticoagulant therapy before assignment * Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion * Pregnant or lactating women * Subject suffering disease affects the understanding of informed consent or comply with study protocol.
References
Publications (1)
- DERIVEDDong R, Jiang S, Chen Y, Ma Y, Sun L, Xing C, Zhang S, Yu K. Prognostic Significance of Cytokine Release Syndrome in B Cell Hematological Malignancies Patients After Chimeric Antigen Receptor T Cell Therapy. J Interferon Cytokine Res. 2021 Dec;41(12):469-476. doi: 10.1089/jir.2021.0057. PMID 34935483