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New treatment option for Acute Lymphoblastic Leukemia, in Relapse
Official title CD19/CD22 CAR-T Cells in Adults With R/R ALL or NHL
ClinicalTrials.gov ID: NCT06445803
What this study is testing
What is KQ-2002 CAR-T cells （CD19/CD22 CAR T-Cells）?
KQ-2002 CAR-T cells （CD19/CD22 CAR T-Cells） is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute lymphoblastic leukemia, in relapse.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female,≥18 years old;
- Histologically confirmed diagnosis of B-ALL or B-NHL(meeting one of the following conditions): (B-NHL)
- Second or greater relapse (CD20 regimens must be included) OR
- Refractory to first-line chemotherapy or relapse within 1 year OR
- Relapse within 1 year of auto-HSCT.
You likely can't join if
- people will be excluded related to the following prior therapy criteria:Prior treatment with bendamustine-containing or fludarabine;Anti-T-cell...
- 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...
- 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...
- Central nervous system (CNS) disease or symptoms of CNS involvement
See the full eligibility criteria
- Male or female,≥18 years old;
- Histologically confirmed diagnosis of B-ALL or B-NHL(meeting one of the following conditions): (B-NHL)
- Second or greater relapse (CD20 regimens must be included) OR
- Refractory to first-line chemotherapy or relapse within 1 year OR
- Relapse within 1 year of auto-HSCT.
- 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...
- ECOG 0\~2
- Estimated survival time ≥ 12 weeks;
- Main tissues and organs function well.
- people 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...
- 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...
- 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 .
The study team makes the final eligibility decision.
Where it's taking place
- Nanchang, Jiangxi, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanchang, Jiangxi, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.