Clinical trial · Interventional
Assessment of Safety and Efficacy of IM19 for Recurrent or Refractory (R/R) Non-Hodgkin's Lymphoma(NHL) Patients
Phase I/II Clinical Study to Evaluate the Safety and Efficacy of IM19 Chimeric Antigen Receptor T Cells(CAR-T) in the Treatment of Recurrent or Refractory (R/R) CD19 Positive Aggressive Non-Hodgkin's Lymphoma
NCT04440436CI-TRIAL-00048703recruitingPhase 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 phase I/II, multicenter study to assess the efficacy and safety of IM19 CAR-T cells in adult with R/R Non-Hodgkins Lymphoma in China.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NHL | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IM19 CAR-T Cells | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IM19 CAR-T cells
- description
- IM19 CAR-T cells be administrated in two dose level
- interventionNames
- Drug: IM19 CAR-T Cells
Primary outcomes (1)
- measure
- Objective Response Rate(ORR) at 90 days
- timeFrame
- 90 days
- description
- The primary endpoint was ORR 90 days after IM19 infusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with relapsed or refractory invasive non-Hodgkin's lymphoma, confirmed by CD19 positive cytology or histology, specific types. * CD20 positive patients undergo corresponding targeted therapy. * Patients must have evaluable evidence of disease (according to Lugano 2014 standards). * ≥ 18 years old. * The expected survival period is more than 3 months. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Women of childbearing age have a negative blood pregnancy test before the start of the trial and agree to have effective contraceptive measures during the trial until the last follow-up * Participate voluntarily in this experiment and sign the informed consent. Exclusion Criteria: * The investigators judged patients with gastrointestinal lymph nodes and/or central nervous system involvement who may be at risk for CAR-T treatment. * Subject has graft-versus-host reactions and need to use immunosuppressants; or suffer from autoimmune disease * Subject has used chemotherapy or radiotherapy within three days before the blood collection period. * Subject has used systemic steroid drugs within 5 days before the blood collection period (except for recent or current inhaled steroids). * Those who use drugs that stimulate bone marrow hematopoietic cells to produce drugs within 5 days before the blood collection * Subject has used any gene therapy products before. * Subject with a history of epilepsy or other central nervous system diseases. * Active Hepatitis B Virus or Hepatitis C Virus infections * The subject with other tumors in the past 5 years. * Within 14 days before enrollment, there was active infection or uncontrollable infection requiring systemic treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.