Clinical trial · Interventional
CD19/CD22 CAR-T Cells in Adults With R/R ALL or NHL
A Preliminary Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetic Profile of KQ-2002 (CD19/CD22 CAR-T) in Adults With Recurrent or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
NCT06445803CI-TRIAL-00077776recruitingPhase 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 study examines the safety, tolerability and preliminary efficacy of anti-CD19 /CD22 CAR T cells (KQ-2002)manufactured on-site in adults with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma.
Conditions
Conditions (4)
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, in Relapse | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Acute Lymphoblastic Leukemia With Failed Remission | — | UNRESOLVED | — |
| B-cell Lymphoma Recurrent | — | UNRESOLVED | — |
| B-cell Lymphoma Refractory | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KQ-2002 CAR-T cells (CD19/CD22 CAR T-Cells) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose escalation
- description
- CD19/CD22-CAR-transduced T cells at escalating doses (0.5\~5.0 ×10\^6 cells/kg)
- interventionNames
- Biological: KQ-2002 CAR-T cells (CD19/CD22 CAR T-Cells)
- type
- EXPERIMENTAL
- label
- Dose expansion
- description
- CD19/CD22-CAR-transduced T cells at MTD or highest dose administered
- interventionNames
- Biological: KQ-2002 CAR-T cells (CD19/CD22 CAR T-Cells)
Primary outcomes (2)
- measure
- Incidence of Dose-limiting toxicity
- timeFrame
- Up to 28 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female,≥18 years old; * Histologically confirmed diagnosis of B-ALL or B-NHL(meeting one of the following conditions): (B-NHL) 1. Second or greater relapse (CD20 regimens must be included) OR 2. Refractory to first-line chemotherapy or relapse within 1 year OR 3. Relapse within 1 year of auto-HSCT. 4. With measurable or evaluable lesions(Dose expansion cohort) (B-ALL) a. Relapse within 12 months of complete remission on first treatment OR b. Relapse after second-line treatment OR c. Relapse after auto HST OR d. Failure to achieve CR/CRi at the end of induction therapy OR e. Ph+ ALL intolerance to TKI or refractory or relapse after treatment with at least two and more TKIs. * ECOG 0\~2 * Estimated survival time ≥ 12 weeks; * Main tissues and organs function well. Exclusion Criteria: * Subjects will be excluded related to the following prior therapy criteria:Prior treatment with bendamustine-containing or fludarabine;Anti-T-cell monoclonal antibody, donor lymphocyte infusion, and CNS radiotherapy within 8 weeks; Chemotherapy, lenalidomide, bortezomib within 2 weeks; vincristine within 1 week; glucocorticoids (prednisone ≥7.5 mg/d or equivalent) within 72 h * Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening * Uncontrolled, symptomatic, intercurrent illness including but not limited to angina pectoris, cerebrovascular accident or transient ischemia (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), New York Heart Association (NYHA) classification of ≥ Class III congestive heart failure, severe arrhythmia poorly controlled by medications, hepatic, renal, or metabolic disorders, and hypertension that is uncontrolled by standard therapy; * active bleeding, or venous thromboembolic event * Autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, etc.) that result in end-organ damage or require systemic application of immunosuppressive drugs * Central nervous system (CNS) disease or symptoms of CNS involvement * Pregnant or nursing (lactating) women * Presence of Grade 2 or above non-hematologic toxicity , alopecia and grade 2 neuropathy excluded * Any Iinappropriate conditions in the opinion of the PI .
References
Publications (0)
Data not yet available
No reference posted for this study.