Clinical trial · Interventional
MC-19PD1 CAR-T in Relapsed or Refractory B Cell Lymphoma
Study Evaluating the Efficacy and Safety of MC-19PD1 CAR-T in Relapsed or Refractory B Cell Lymphoma
NCT03932955CI-TRIAL-00038408unknownPhase 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 center, single arm, open-lable phase 1 study to determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory B-cell 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 |
|---|---|---|---|
| MC-19PD1 CAR-T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MC-19PD1 CAR-T Cells
- interventionNames
- Biological: MC-19PD1 CAR-T cells
Primary outcomes (1)
- measure
- Percentage of adverse events
- timeFrame
- 2 years
- description
- Percentage of participants with adverse events
Secondary outcomes (1)
- measure
- objective remission rate
- timeFrame
- 3 months
- description
- The percentage of participants who achieved complete remission (CR) and partial remission over all participants (ORR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: (1)CD19 positive B-cell lymphoma; (2)Relapsed and refractory B-cell lymphoma: patients previously received at least first-line and second- line treatment and fail to achieve CR; (3)At least 1 measurable tumor foci according to the 2014 Lugano treatment response criteria; (4)18 to 70 Years Old, Male and female; (5)Expected to survive for more than 3 months; (6)Clinical performance status of ECOG score 0-1; (7)Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%; serum Cr ≤ 1.25 times normal range or creatinine clearance calculated by Cockcroft-Gault formula ≥45ml/min; ALT and AST≤ 3 times normal range, total bilirubin ≤ 1.5times normal range; (8)hemoglobin ≥ 80 g / L, neutrophils ≥ 1.0 × 10 \^ 9 / L, platelets ≥ 50 × 10 \^ 9 / L. (9)INR≤ 1.5times normal range; APTT≤ 1.5times normal range; (10)Women in childbearing age must be not pregnant and do not plan pregnancy within 1 year of their cell transfusion; (11)Informed consent is signed by a subject or his lineal relation. Exclusion Criteria: 1. Recent or current use of glucocorticoid or other immunosuppressor or Drug that stimulates bone marrow hematopoiesis; 2. Uncontrolled systemic active infection: fungi, bacteria, viruses or other infections; 3. Active infection with HBV, HCV or HIV; 4. Patients with symptoms and disease history of central nervous system; 5. Pregnant or lactating female;The patient did not agree to use effective contraception during the treatment period and for the following 1 year; 6. Patients receiving allogeneic hematopoietic stem cell transplantation, or organ transplantation 7. A history of other malignant tumors; 8. Primary immunodeficiency disease, or autoimmune disease; 9. Patients treated with PD-1 inhibitors or PD-L1 inhibitors prior to enrollment; 10. Patients who participated in other clinical trials within 4 weeks before blood collection; 11. Patients who had used CD19 targeted therapy before enrollment; 12. The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.
References
Publications (0)
Data not yet available
No reference posted for this study.