Clinical trial · Interventional
Clinical Study of CAR-T Technology for the Treatment of Relapsed Refractory Malignant Haematological Tumours
NCT06238336CI-TRIAL-00073602unknownPhase 2 / Phase 3ClinicalTrials.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)
The trial is designed as an early exploratory single-centre, open, single-arm clinical trial. The trial is planned to evaluate the safety and efficacy of CAR-T for the treatment of relapsed refractory malignant haematological tumours. The trial is divided into five visit periods as follows: screening period, non-myeloablative pretreatment, short-term follow-up period, mid-term follow-up period and exit visit.
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 |
|---|---|---|---|
| Hematological Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAR-T cell therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAR-T cell therapy
- description
- Dose climbing started with 1.0\*10\^6/kg back infusion, 3 patients per dose group, if there is no adverse reaction the dose can be increased to 2.0\*10\^6/kg, 4.0\*10\^6/kg, the maximum dose can be extended the study.
- interventionNames
- Drug: CAR-T cell therapy
Primary outcomes (1)
- measure
- Incidence of treatment-related adverse events
- timeFrame
- Up to 36 months
- description
- Adverse events associated with CAR-T therapy, serious adverse events and clinically significant laboratory test abnormalities.
Secondary outcomes (6)
- measure
- CAR-T amplification levels
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. patients or their legal guardians voluntarily participate and sign an informed consent form; 2. male or female patients aged 14 to 70 years (inclusive); 3. be diagnosed as malignant haematological tumour by pathological and histological examination; 4. have a measurable or evaluable lesion; 5. the patient has good function of major tissues and organs: (1) Liver function: ALT/AST \<3 times upper limit of normal (ULN) and total bilirubin ≤34.2 μmol/L; (2) Renal function: creatinine \<220 μmol/L; (3) Lung function: room oxygen saturation ≥95%; (4) Cardiac function: left ventricular ejection fraction (LVEF) ≥40%. (6) Patient's peripheral superficial venous blood flow is smooth and can meet the demand of intravenous drip; 7. patients with ECOG score ≤2 and expected survival time ≥3 months. Exclusion Criteria: 1. Women who are pregnant (positive urine/blood pregnancy test) or breastfeeding; 2. men or women who are planning to conceive within the last 1 year; 3. patients who cannot guarantee effective contraception (condoms or birth control pills, etc.) within 1 year of enrolment; 4. patients with uncontrolled infections within 4 weeks prior to enrolment; 5. active viral hepatitis B/C; 6. patients with HIV infection; 7. patients with severe autoimmune diseases or immunodeficiency diseases; 8. patients who are allergic to large molecule biopharmaceuticals such as antibodies or cytokines; 9. patients who have participated in other clinical trials within 6 weeks prior to enrolment; 10. the patient has used hormones systematically within 4 weeks prior to enrolment (except for patients using inhaled hormones); 11. the patient has a psychiatric disorder 12. the patient has substance abuse/addiction; 13. other conditions that, in the judgement of the investigator, make the patient unsuitable for enrolment.
References
Publications (0)
Data not yet available
No reference posted for this study.