NCT07447726
Not yet recruiting
Phase 1
Exploratory Clinical Study on the Safety and Efficacy of CD19X CAR-T Cell Injection in the Treatment of Relapsed/Refractory Large B-Cell Lymphoma
Institute of Hematology & Blood Diseases Hospital, China0 sites3 target enrollmentStarted: April 5, 2026Last updated:
InterventionsCD19X CAR-T
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 3
- Primary Endpoint
- Incidence and severity of adverse events
Overview
Brief Summary
This study is an open-label, single-arm, prospective, exploratory clinical trial involving patients with relapsed/refractory large B-cell lymphoma, aiming to preliminarily assess the safety and efficacy of CAR-T cell infusion.
Detailed Description
This study is an open-label, single-arm, prospective, exploratory clinical trial targeting patients with relapsed/refractory large B-cell lymphoma. It plans to enroll 3 participants, where the investigator will administer a dose of 1-2×10^6 CAR cells/kg of CAR-T cell infusion and follow up to observe related data on post-treatment adverse reactions and therapeutic effects, with the aim of preliminarily evaluating the safety and efficacy of the CAR-T cell infusion.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1\. The participant has given consent and signed the informed consent form, and is willing and able to comply with planned visits, research treatments, laboratory tests, and other trial procedures;
- •2\. Clinically diagnosed with relapsed/refractory large B-cell lymphoma, and confirmed by pathology or flow cytometry that tumor cells express CD19, including: diffuse large B-cell lymphoma (DLBCL), transformed indolent B-cell lymphoma to DLBCL (excluding Richter transformation), and meeting the following criteria (satisfying one of the first two and the third): i. Relapse ≥6 months after achieving remission following first-line adequate therapy or ≥12 months after stem cell transplantation; ii. Patients who did not achieve remission after at least 2-4 cycles of first-line chemotherapy combined with high-risk factors (double-expressor lymphoma, double-hit lymphoma, TP53 gene mutation or deletion, IPI score ≥3), or disease progression during first-line therapy, or progression within 6 months after achieving remission from prior sufficient therapy, or relapse within 12 months after achieving remission from stem cell transplantation; iii. The participant has received the following treatments for LBCL after diagnosis:
- •Anti-CD20 monoclonal antibody;
- •Combination chemotherapy containing anthracyclines.
- •3\. Age 18 years and above, both male and female;
- •4\. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- •5\. Expected survival of more than 3 months from the date of signing the informed consent form;
- •6\. HGB ≥ 60 g/L (blood transfusion allowed); LYM ≥ 0.3\*10\^9/L;
- •7\. Liver and kidney function, as well as cardiopulmonary function, must meet the following requirements:
- •Creatinine ≤ 1.5×ULN;
Exclusion Criteria
- •1\. Severe heart failure with left ventricular ejection fraction \<50%;
- •2\. History of severe pulmonary dysfunction;
- •3\. Concurrent progressive malignant tumors;
- •4\. Severe infections that cannot be effectively controlled;
- •5\. Severe autoimmune diseases or congenital immunodeficiency;
- •6\. History of CAR-T cell immunotherapy;
- •7\. Active hepatitis (hepatitis B virus DNA \[HBV-DNA\] or hepatitis C virus RNA \[HCV-RNA\] levels above the detection limit);
- •8\. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
- •9\. History of severe allergic reactions to biological products (including antibiotics);
- •10\. Allogeneic hematopoietic stem cell transplant patients who still have acute graft-versus-host disease (GvHD) one month after discontinuing immunosuppressive drugs.
Arms & Interventions
CD19X CAR-T
Other
Intervention: CD19X CAR-T (Drug)
Outcomes
Primary Outcomes
Incidence and severity of adverse events
Time Frame: Within 28 days after CAR-T infusion
Evaluate the possible adverse reactions recorded after CAR-T infusion, mainly including the number of cases, incidence, and severity of immune-related toxicities such as cytokine release syndrome, immune effector cell-associated neurotoxicity, and hematologic toxicities.
Secondary Outcomes
- Efficacy indicators(At 1 and 3 months after CAR-T infusion)
- Cell Metabolic Kinetics Indicators(On the 7th, 10th, 14th, and 28th days after treatment)
- Cellular Metabolic Kinetics Indicators(On the 7th, 10th, 14th, and 28th days after treatment)
- Cellular Metabolic Kinetics Indicators(Day 28 after treatment)
- Exploratory indicators(The CAR-T single-cell phenotype and clonal characteristics are tested on the day of cell infusion. Follow-up is conducted on D10 and D28 after infusion, once a month from M2 to M3, every three months from M6 to Y1, and every three months from Y1 to Y2.)
Investigators
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