Clinical trial · Interventional
HM2014-26 DT2219 for Relapsed or Refractory B-Lineage Leukemia or Lymphoma
HM2014-26 DT2219 Immunotoxin for the Treatment of Relapsed or Refractory CD19 (+) and/or CD 22 (+) B-lineage Leukemia or Lymphoma
- 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 phase I/II study of DT2219 for the treatment of relapsed or refractory CD19 (+) and/or CD 22 (+) B-lineage leukemia and lymphoma. The study consists of two phases - a phase I dose/schedule finding component using the maximum tolerated dose identified during the previous phase I study, but with a higher number of doses and a two-stage phase II extension component to confirm safety and make a preliminary determination of the activity level by disease using the dose identified in phase I.
Conditions
Conditions (4)
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-Lineage Leukemia | — | UNRESOLVED | — |
| Refractory B-Lineage Lymphoma | — | UNRESOLVED | — |
| Relapsed B-Lineage Leukemia | — | UNRESOLVED | — |
| Relapsed B-Lineage Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DT2219ARL | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DT2219ARL
- description
- A recombinant bispecific antibody-targeted toxin.
- interventionNames
- Biological: DT2219ARL
Primary outcomes (2)
- measure
- Phase I: Incidence of Any DLT Attributed to DT2219 in the First Cycle
- timeFrame
- Day 1 - Day 29
- description
- Dose limiting toxicity (DLT) is defined as any of the following adverse events occurring from study day 1 through 7 days after the last dose of DT2219 of the 1st treatment cycle, and not clearly attributed to the primary malignancy or intercurrent illness: * any Grade 5 adverse event * any Grade 4 neutropenia or thrombocytopenia lasting more for than 7 days * any Grade 3 thrombocytopenia with bleeding * any Grade 4 non-hematologic adverse event during DT2219 infusion * any Grade 3 non-hematologic adverse event occurring after completion of DT2219 infusion
- measure
- Phase ll: Overall Disease Response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic verification of B-cell lineage leukemia or B cell non-Hodgkin lymphoma and evidence of relapse/refractory disease with the presence of CD19 and/or CD22 by flow cytometry or immunohistochemistry of bone marrow aspirate, peripheral blood or node/tumor biopsy * Relapsed refractory disease that has failed conventional therapy and other therapies of higher priority * Karnofsky Performance status of ≥ 60% or, if less than 16 years of age, Lansky Play Score of ≥ 60 (appendix II) * Recovered from effects of prior therapy * Peripheral blast count under 50 x 10\^9/L * Adequate organ function within 14 days (30 days for cardiac and pulmonary) of treatment start * Women of childbearing potential and men should be advised and agree to practice effective methods of contraception during the course of study * Voluntary written consent with appropriate parent/guardian consent and minor information sheet for participants \< 18 years of age Exclusion Criteria: * Presence of leukemic or infectious pulmonary parenchymal disease * Presence of active CNS leukemia * Presence of any uncontrolled systemic infection * Documented uncontrolled seizure disorder- a seizure disorder controlled with medication * Active neurologic disorder - peripheral neuropathy alone does not exclude a patient * Active Hepatitis B or Hepatitis C (virus detectable by PCR) * Documented penicillin or cephalosporin allergies * Pregnant or lactating
References
Publications (0)
Data not yet available