Clinical trial · Interventional
Anti-CD19 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphomas
Study Evaluating the Safety and Efficacy With Anti-CD19 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphomas
NCT04196205CI-TRIAL-00042206unknownPhase 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 single arm, open-label, single center study to determine the safety and efficacy of Anti-CD19 CAR-T cells in patients with relapsed or refractory acute lymphoblastic leukemia and Lymphomas.
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 |
|---|---|---|---|
| Acute Lymphoblastic Leukemia ,Lymphomas | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-CD19 CAR-T | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Anti-CD19 CAR-T
- description
- Anti-CD19 CAR-T
- interventionNames
- Biological: Anti-CD19 CAR-T
Primary outcomes (4)
- measure
- Overall responce rate(ORR)
- timeFrame
- 2 years
- description
- Assessment of ORR (ORR = CR+PR ) at 2 months of treatment
- measure
- Overall survival (OS)
- timeFrame
- 2 years
- description
- Assessment of OS(Overall survival) at 6 months of treatment
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: Subjects diagnosed as Relapsed or Refractory acute lymphoblastic leukemia and Lymphomas ,and have no effective treatment option (such as autograft or allogeneic stem cell transplantation) and estimated survival time of the current treatment \< 2 years, The specific requirements are as follows: 1. Male or female aged 18-70 years old ; 2. Estimated Survival time \> 12 weeks; 3. Relapsed and refractory acute lymphoblastic leukemia and lymphoma were confirmed by physical examination, pathological examination, laboratory examination and imaging; 4. Chemotherapy failure or recurrent acute lymphoblastic leukemia and Lymphomas; 5. Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase\< 3 fold of normal level; 6. Bilirubin\<2.0mg/dl; 7. Karnofsky Performance Status\>50% at the time of screening; 8. Adequate pulmonary, renal, hepatic, and cardiac function; 9. Fail in autologous or allogenic haemopoietic stem cell transplantation; 10. Not suitable for stem cell transplantation conditions or abandoned due to conditions; 11. Free of leukocytes removal contraindications; 12. Voluntarily join CAR-T clinical trial ,Understand and sign written informed consent. Exclusion Criteria: 1. The patient is a pregnant or breastfeeding woman, or is a woman with a pregnancy plan within six months; 2. Patients have infectious diseases (such as HIV, active tuberculosis, etc.); 3. The patient is an active hepatitis B or hepatitis C infection; 4. Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated ; 5. Abnormal vital signs; 6. Subjects with mental or psychological illness who cannot be combined with treatment and efficacy evaluation; 7. Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2; 8. General infection or local severe infection, or other infection that is not controlled; 9. Dysfunction in lung, heart, kidney and brain; 10. Severe autoimmune diseases; 11. Other symptoms that are not applicable for CAR-T.
References
Publications (0)
Data not yet available
No reference posted for this study.