Clinical trial · Interventional
A Clinical Study Evaluating the Safety and Efficacy of BinD19 Treatment in R/R ALL and Lymphoma Subjects
A Clinical Study Evaluating the Safety and Efficacy of BinD19 Treatment in Relapse or Refractory Acute Lymphoblastic Leukemia and Lymphoma Subjects
NCT03156101CI-TRIAL-00049863unknownPhase 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)
This is a single arm, open-label, uni-center, phase I/II study to determine the safety and efficacy of an experimental therapy called BinD19 cells in patients with B-cell acute lymphoblastic leukemia or lymphoma, who are chemo-refractory, relapsed after allogeneic SCT, or are otherwise ineligible for allogeneic stem cell transplant.
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 |
|---|---|---|---|
| Refractory B-cell Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Relapsed B-cell Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Relapsed／Refractory B-cell Lymphoma | Burkitt Lymphoma | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BinD19 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BinD19
- description
- BinD19 (autologous T cells transduced with CD19 TCR-ζ/4-1BB vector) administered as an IV infusion on days 0, 1 and 2 in the absence of disease progression or unacceptable toxicity. Minimum/maximum dose: 1x10\^6/kg / 1x10\^7/kg administered to patients with R/R B cell Acute Lymphoblastic Leukemia (ALL) or Lymphoma.
- interventionNames
- Biological: BinD19
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events [Safety and Feasibility]
- timeFrame
- Study treatment until Week 24
- description
- Occurrence of study related adverse events defined as NCI CTCAE 4.0 \> grade 3 possibly, probably, or definitely related to study treatment.
Secondary outcomes (1)
- measure
- Overall Response [Efficacy]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 70 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 * 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+: * Disease responding or stable after most recent therapy (chemotherapy, MoAb, etc) * ECOG result is 0, 1 or 2. * With normal heart, liver and kidney functions. * Negative serum antibody for EBV, CMV, HBV, HCV, HIV and syphilis. * Negative in pregnancy test （female subject only). Exclusion Criteria: * ECOG result is 3, 4 or 5. * Pregnant or lactating women * 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 * HIV infection * Enrolled to other clinical study in the last 4 weeks. * Subjects with systemic auto-immune disease or immunodeficiency. * Subjects with CNS diseases. * Subjects with secondary tumors. * Subjects with tumor infiltration in liver, brain or GI tract.
References
Publications (1)
- DERIVEDChen X, Li X, Liu Y, Zhang Z, Zhang X, Huang J, Li H, Li F, Zhang L, Li L, Wu X, Ma W, Sun Z, Yu H, Zhou Z, Feng X, Cui K, Li Z, Zhang H, Zeng Y, Wan X, Chen YH, Zhang M, Zhang Y. A Phase I clinical trial of chimeric antigen receptor-modified T cells in patients with relapsed and refractory lymphoma. Immunotherapy. 2020 Jul;12(10):681-696. doi: 10.2217/imt-2020-0022. Epub 2020 Jun 25. PMID 32580597