CAR-T cell therapy for adults with relapsed or refractory leukemia and lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.