Treatment for relapsed or refractory B-cell lymphoma using triple-targeted cell therapy

A Phase I, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LCAR-AIO, a Triple-targeted Cell Preparation Targeting CD19/CD20/CD22, in Patients With Relapsed/Refractory B-cell Lymphoma

This study is testing a new cell therapy for adults with relapsed or hard-to-treat B-cell lymphoma to see if it can help them feel better.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (other)
• Drugs / interventions: CAR-T, chemotherapy
• Locations: 2 sites (Beijing, Beijing and 1 other locations)
• Trial ID: NCT05318963 on ClinicalTrials.gov

What this trial studies

This phase I, open-label clinical study evaluates the safety, tolerability, and efficacy of LCAR-AIO, a triple-targeted cell preparation that targets CD19, CD20, and CD22 in patients aged 18 to 75 with relapsed or refractory B-cell lymphoma. Participants will undergo a screening phase, followed by pre-treatment involving lymphodepleting chemotherapy, and then receive a single dose of the LCAR-AIO injection. The study aims to assess the response of patients to this innovative therapy through a structured follow-up process.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed B-cell lymphoma expressing CD19, CD20, or CD22 who have relapsed or are refractory to previous treatments.

Not a fit: Patients who do not express CD19, CD20, or CD22 or those with other types of lymphoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell lymphoma.

How similar studies have performed: Other studies targeting similar pathways have shown promise, suggesting potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

1. Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent.
2. Aged 18-75 years (inclusive).
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Histologically confirmed B-cell lymphoma that expresses at least one of CD19/CD20/CD22.
5. At least one measurable tumor lesion determined according to Lugano 2014 criteria.
6. Response to prior therapy is consistent with one of the following:

   1. Primary refractory: it means that the best response to first-line therapy (at least 2 cycles) is PD, or best response to first-line therapy (at least 4 cycles) is SD but the duration is less than 6 months, which is considered to be PD;
   2. Relapsed or refractory after 2 or more lines of therapy. Refractory is defined that best respond to the most recent treatment regimen (at least 2 cycles) is PD, or best response to the most recent treatment regimen (at least 4 cycles) is SD but the duration is less than 6 months, which is considered to be PD;
   3. Progression or relapse within 12 months after hematopoietic stem cell transplantation; if salvage therapy is applied after transplantation, the patient must be unresponsive or relapsed to the last line of therapy;
7. Life expectancy≥ 3 months
8. Clinical laboratory values meet screening visit criteria
9. Adequate organ function;

Exclusion Criteria:

Subject eligible for this study must not meet any of the following criteria:

1. Prior antitumor therapy with insufficient washout period ;
2. Patients who received dual-targeted CAR-T cell therapy (including but not limited to sequential infusion) at any time in the past, or who received CAR-T cell therapy of cameloid origin;
3. With acute or chronic graft-versus-host disease (GvHD);
4. Patients who are positive for any index of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), or human immunodeficiency virus antibody (HIV- Ab).
5. Known life-threatening allergies, hypersensitivity, or intolerance to LCAR-AIO CAR-T cell or its excipients, including DMSO (refer to Investigator's Brochure).
6. Pregnant or lactating women;

Where this trial is running

Beijing, Beijing and 1 other locations

• Beijing Gobroad Boren Hospital — Beijing, Beijing, China (RECRUITING)
• Institute of Hematology & Blood Diseases Hospital — Tianjin, Tianjin, China (RECRUITING)

Study contacts

• Study coordinator: Wei Liu

Conditions: B-cell Lymphoma Recurrent, B-cell Lymphoma Refractory