Clinical trial · Interventional
Assessment of Safety and Efficacy of ThisCART19A in Adult Patients With B Cell Malignancies After Failure of Autologous Chimeric Antigen Receptor T- Cell(CAR-T) Therapy
A Single Dose-escalation Study to Evaluate the Safety and Efficacy of Allogeneic CAR-T Targeting CD19 (ThisCART19A) in Adult Patients With B Cell Malignancies After Failure of Autologous Chimeric Antigen Receptor T- Cell(CAR-T) Therapy
- 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 a phase 1, open label study to assess the safety and efficacy of ThisCART19 (Allogeneic CAR-T targeting CD19) in adult patients with B cell malignancies after failure of autologous chimeric antigen receptor T- cell(CAR-T) therapy in china.
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 |
|---|---|---|---|
| Allogeneic, CAR-T, Protein Sequestration, Non-gene Edited | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine Pill | Drug | — | UNRESOLVED |
| ThisCART19A | Drug | — | UNRESOLVED |
| VP-16 Protocol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ThisCART19A cells infusion
- description
- In this study, allogeneic anti-CD19 CAR T cell (ThisCART19A) infusion is used to treat patients with refractory or relapsed CD19 positive B cell acute lymphoblastic leukemia.
- interventionNames
- Drug: ThisCART19A
- Drug: Fludarabine Pill
- Drug: Cyclophosphamide
- Drug: VP-16 Protocol
Primary outcomes (3)
- measure
- Dose limited toxicity(DLT) observation in patient with B Cell Malignancy in each dose level during dose escalation stage
- timeFrame
- 28 days
- description
- DLT is defined as the incidence of severe adverse events related to ThisCART19A more than 33% in each dose level.
- measure
- Objective Response Rate within 3 months during dose expansion stage
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient with relapsed or refractory acute lymphocytic leukemia, or lymphoma; 2. No gender limitation, Age 14 years to 75 years (both upper and lower limits included); 3. Failing to autologous CAR-T therapy; 4. Should be confirmed Cluster of differentiation(CD)19 positive; 5. The expected survival time is ≥12 weeks; 6. ECOG score 0-1; 7. Measurable or detectble disease at time of enrollment. 8. Adequate bone marrow, renal, hepatic, pulmonary and cardiac function; Exclusion Criteria: 1. Allergic to preconditioning measures; 2. Patients with other malignancies other than B-cell malignancies within 5 years prior to screening. Patients with cured skin squamous carcinoma, basal carcinoma, non-primary invasive bladder cancer, localized low-risk prostate cancer, in situ cervical/breast cancer can be recruited; 3. Uncontrollable bacterial, fungal and viral infection during screening; 4. Patients had pulmonary embolism (PE) and/or deep vein thrombosis (DVT) within 3 months prior to enrollment; 5. Had intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases prior to enrollment; 6. The presence of central nervous system involvement; 7. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) or Human immunodeficiency virus (HIV) or Syphilis infection. HBV-DNA \< 2000 IU/mL can be enrolled, but should admitted to use anti-virus drugs such as entecavir, tenofovir, etc, and supervisory the relative indication during the treatment; 8. Had big lesion(single lesion diameter ≥10 cm); 9. Receive allogeneic hematopoietic stem cell transplantation less than 100 days; 10. Vaccinated with influenza vaccine within 2 weeks prior to cleansing (SARS-COV19 can be included, inactivated, live/non-live adjuvant vaccinations allowed to be included); 11. Patients who are receiving GvHD treatment; Patients without GvHD and who had stopped immunosuppressive drugs for at least 1 month were eligible for inclusion; 12. Women who are in pregnant or lactating, and female subjects or partners who plan to be pregnant within 1 year after cell infusion. Male subjects who plan pregnancy within 1 year after infusion.
References
Publications (0)
Data not yet available