Clinical trial · Interventional
Evaluate the Safety and Effect of ThisCART19A in Patients With AIDS Related B Cell Lymphoma/Lympholeukemia
To Evaluate the Safety, Efficacy, Pharmacokinetics of ThisCART19A in Patients With AIDS Related B Cell Lymphoma/Lympholeukemia
NCT05340829CI-TRIAL-00057994unknownPhase 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 an open label, phase I study to assess the safety and efficacy of ThisCART19A in patients with AIDS related B cell lymphoma/lympholeukemia.
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 |
|---|---|---|---|
| AIDS Related Lymphoma and Lympholeukemia | AIDS-Related Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ThisCART19A | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- ThisCART19A 2×10^6 cells/kg for dose level 1
- description
- Patients will receive 2×10\^6 cells/kg of ThisCART19A
- interventionNames
- Biological: ThisCART19A
- type
- EXPERIMENTAL
- label
- ThisCART19A 3×10^6 cells/kg as dose level 2
- description
- Patients will receive 3×10\^6 cells/kg of ThisCART19A
- interventionNames
- Biological: ThisCART19A
- type
- EXPERIMENTAL
- label
- Patients will receive 4×10^6 cells/kg as dose level 3
- description
- Patients will receive 4×10\^6 cells/kg of ThisCART19A
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-65. * Patients with AIDS-associated B-cell lymphoma/leukemia, including but not limited to diffuse large B-cell lymphoma (DLBCL), follicular lymphoma tranferring to DLBCL, mantle cell lymphoma (MCL), follicular lymphoma 3B (FL-3B), original Mediastinal (thymus) large B-cell lymphoma, high-grade B-cell lymphoma and leukemia. * At least received first line treatment. * Had available evaluation lesion. * ECOG(Eastern Cooperative Oncology Group) ≤ 1 or Karnofsky ≥ 60%. * Had good organic function within 4 weeks before enrollment: Alanine aminotransferase(ALT)≤5×ULN(Upper limit of normal) and total bilirubin(TBIL)\<2.0 mg/dL(for patients with Gilbert heald diseases, live involvement and taking atazanavir or indinavir, TBIL\<3.0 mg/dL can be enrolled.); Left ventricular ejection fraction(LVEF)≥40%; Absolute neutrophile counts≥1000/mm3; thrombocyte≥30000/mm3; Serum creatinine≤1.5×ULN or creatinine clearance\>30 mL/min/1.73 m2. * Confirmed Cluster of differentiation(CD)19 positive by biopsy for the patients who received CD19 target therapy before. * Confirmed Human immunodeficiency virus(HIV)-1 infection. * HIV virus loading \< 200 copy/ml within 4 weeks before screening. * CD4+T cell counts \>50 cells/mm3 within 4 weeks before screening. * Patients with TBIL≤ 1.5 mg/dL, Aspartate aminotransferase(AST) and ALT ≤ 3×ULN, and hepatitis B virus(HBV) DNA \<2000 IU/ml can be enrolled for HBV positive patients(defined as hepatitis B virus surface antigen(HBsAg) positive and hepatitis B core(HBc)-total positive ) and hepatitis C virus(HCV) positive patients(defined as HCV antibody positive) . Patients with cirrhosis are excluded. * Hepatitis B core antibody(HBcAb) positive patients enrolled in this trial have to taking anti-HBV drugs during the whole research. Exclusion Criteria: * Known for allergic to the preconditioning measures. * Uncontrollable bacterial, fungal, viral infection before enrollment. * Patients with pulmonary embolism within 3 months prior enrollment. * Intolerable serious cardiovascular and cerebrovascular diseases and hereditary diseases. * Imaging confirmed the presence of central nervous system involvement(including primary and secondary) and rapid progressing diseases. * Receive allogeneic hematopoietic stem cell transplantation. * Systemic steroid use (e.g., prednisone ≥20mg) within 3 days prior to screening. iIntermittent use of topical, inhaled or intranasal steroids recently or currently. Or systemic disease requiring long-term use of immunosuppression drugs. * Excluded the patients received Influenza vaccinations within 2 weeks prior to lymphodepletion (Received Severe Acute Respiratory Syndrome-Corona virus disease(SARS-COV)19 vaccines could be included. Received inactivated, live/non-live adjuvant vaccines could be enrolled). * Excluded women who are in pregnant or lactating, and female subjects or partners who plan to be pregnant within 1 year after infusion. Male subjects planning pregnancy within 1 year after infusion should be excluded.
References
Publications (0)
Data not yet available
No reference posted for this study.