Clinical trial · Interventional
Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Malignant Lymphoma
Clinical Study on the Safety and Effectiveness of Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Malignant Lymphoma
NCT05239676CI-TRIAL-00056529unknownEarly Phase 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)
Clinical Study on the Safety and Effectiveness of Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Malignant Lymphoma
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 |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous hematopoietic stem cell transplantation combined with CD19 CAR-T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment of Lymphoma
- description
- Refractory and relapsed malignant lymphoma
- interventionNames
- Biological: Autologous hematopoietic stem cell transplantation combined with CD19 CAR-T cells
Primary outcomes (2)
- measure
- overall response rate
- timeFrame
- Up to 30 months
- description
- the number of response patients/the number of total patients
- measure
- Incidence of treatment-emergent adverse events (TEAEs)
- timeFrame
- 24 months after cell infusion
- description
- Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* 1.Male or female, 18-75 years old (including the threshold value); 2. According to the 2016 WHO classification criteria for lymphocytic tumors, histologically confirmed include: DLBCL (NOS); follicular lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma transformed DLBCL, and PMBCL and high-grade B-cell lymphoma Subject.
3.R/R B-NHL (conform one of the following conditions)
1. The subject did not remission or relapsed after receiving second-line or higher-line chemotherapy
2. Primary resistance
3. The subject relapsed after receiving autologous hematopoietic stem cell transplantation
Exclusion Criteria:
* Subjects with any of the following exclusion criteria were not eligible for this trial:
1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
3. Pregnant (or lactating) women;
4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
5. Active infection of hepatitis B virus or hepatitis C virus;
6. Those who have used any gene therapy products before.
7. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
8. Serum creatinine \> 2.5mg/dl or ALT / AST \> 3 times ULN or bilirubin \> 2.0mg/dl;
9. Those who suffer from other uncontrolled diseases are not suitable to join the study;
10. HIV infection;
11. Any situation that the researchers believe may increase the risk of patients or interfere with the test results.References
Publications (0)
Data not yet available
No reference posted for this study.