CAR-T cell therapy for adults with relapsed or refractory leukemia and lymphoma
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
This study is testing a new CAR-T cell therapy to see if it can help adults with tough-to-treat leukemia or lymphoma feel better and fight their cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, fludarabine, prednisone, CAR T, CAR-T, cyclophosphamide |
| Locations | 2 sites (Nanchang, Jiangxi and 1 other locations) |
| Trial ID | NCT06445803 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety, tolerability, and preliminary efficacy of KQ-2002 CAR T cells targeting CD19 and CD22 in adults with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) or B-cell non-Hodgkin lymphoma (B-NHL). Participants will undergo leukapheresis to collect their cells, followed by lymphodepleting chemotherapy to prepare their bodies for the CAR T cell infusion. The infusion occurs 2-7 days after chemotherapy, and patients will be monitored for two years post-infusion for efficacy and side effects, with long-term follow-up extending up to 15 years. This approach aims to enhance the immune response against cancer cells expressing CD19 and CD22 antigens.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with relapsed or refractory B-ALL or B-NHL who meet specific eligibility criteria.
Not a fit: Patients who have previously received certain therapies, such as bendamustine or fludarabine, may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat forms of leukemia and lymphoma.
How similar studies have performed: Other studies utilizing CAR-T cell therapy have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 .
Where this trial is running
Nanchang, Jiangxi and 1 other locations
- The First Affiliated Hospital of Nanchang University; — Nanchang, Jiangxi, China (Recruiting)
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Rong Tao, MD — Fudan University
- Study coordinator: Weijing Zhang
- Email: JJYIN555@163.com
- Phone: 021-64175590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.