Clinical trial · Interventional
Treatment of Hematological Malignancy With Novel CAR-T Cells.
Adoptive Immunotherapy for Hematological Malignancy With Novel CAR-T Cells.
NCT04191941CI-TRIAL-00042146unknownEarly 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)
This is a single arm, open-label, early phase I study, to determine the safety and efficacy of Novel CAR-T cell therapy in Hematological Malignancy treatment.
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 |
|---|---|---|---|
| B-cell Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| B-cell Non Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Novel CAR-T | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Novel CAR-T
- description
- Novel CAR-T cells will be administered intravenously
- interventionNames
- Biological: Novel CAR-T
Primary outcomes (1)
- measure
- safety (Incidence of treatment-related adverse events as assessed by CTCAE v4.03)
- timeFrame
- 3 months
- description
- Incidence of treatment-related adverse events as assessed by CTCAE v4.03
Secondary outcomes (5)
- measure
- Complete response rate[CR] (Complete response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma)
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria:
1. All subjects must personally sign and date the consent form before initiating any study specific procedures or activities;
2. All subjects must be able to comply with all the scheduled procedures in the study;
3. Clear diagnosis of hematological malignancy, including B-cell Non-Hodgkin lymphoma, B-cell lymphoblastic leukemia, multiple myeloma.
4. Fufill one or more of the following criteria: Relapsed after most recent therapy; Progressive disease in standard chemotherapy; Disease progression or relapsed after ASCT;
5. At least one clear indicator for hematological malignancy monitoring;
6. Aged \<70 years;
7. Expected survival ≥12 weeks;
8. Eastern cooperative oncology group (ECOG) performance status of≤3;
9. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks;
10. All other treatment induced adverse events must have been resolved to
≤grade 1;
11. Laboratory tests must fulfill the following criteria: ANC ≥ 1000/uL, HGB\>70g/L, Platelet count ≥ 50,000/uL, Creatinine clearance ≤1.5 ULN, Serum ALT/AST ≤2.5 ULN, Total bilirubin ≤1.5 ULN (except in subjects with Gilbert's syndrome);
Exclusion Criteria:
1. Presence of fungal, bacterial, viral, or other infection that is hardly to control (defined by investigator);
2. Patients with symptomatic central nervous system metastasis, intracranial metastasis, and cancer cells found in cerebrospinal fluid are not recommended to participate in this study. Symptom free or post-treatment stable disease or disappearance of lesions should not be excluded. The specific selection is ultimately determined by the investigator;
3. Lactating women or women of childbearing age who plan to conceive during the investigational time period;
4. Active infection with hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive);
5. Known history of infection with HIV;
6. Subjects need systematic usage of corticosteroid;
7. Subjects need systematic usage of immunosuppressive drug;
8. Planed operation, history of other related disease, or any other related laboratory tests restrict patients for the study;
9. Other reasons the investigator consider the patient may not be suitable for the study.References
Publications (0)
Data not yet available
No reference posted for this study.