Bispecific CAR-T cell therapy for relapsed B-cell cancers
CD19/CD22 Bispecific CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma or Acute Lymphoblastic Leukemia: a Prospective, Single-arm, Single-center, Phase 2 Clinical Trial
This study is testing a new type of CAR-T cell therapy that targets two cancer markers to see if it helps people with relapsed B-cell cancers feel better and have better outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 14 Years to 85 Years |
| Sex | All |
| Sponsor | Beijing Tongren Hospital Academic / other |
| Drugs / interventions | CAR-T |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06081478 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of a novel CD19/CD22 bispecific CAR-T cell therapy in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) or diffuse large B-cell lymphoma. The approach aims to improve outcomes by targeting both CD19 and CD22 antigens, addressing the common issue of relapse associated with CD19-only therapies. Participants will receive the bispecific CAR-T cells and will be monitored for treatment response and safety over the course of the trial.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 14 to 85 with CD19/CD22 positive B-cell lymphoma or B-ALL who have relapsed or are refractory to standard treatments.
Not a fit: Patients with uncontrolled infections, active hepatitis, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a more effective treatment option for patients with relapsed B-cell malignancies, potentially reducing the rate of relapse.
How similar studies have performed: While CAR-T therapies have shown promise, this specific bispecific approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 14 years to 85 years, expected survival \> 3 months; * CD19/CD22 positive B-cell lymphoma or B-ALL; * relapsed or refractory to standard first-line treatment; * ECOG-PS score=0-2; * Having at least one measurable lesions; * Cardiac function: 1-2 levels; * Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN; * kidney: Cr≤1.25ULN; * bone marrow: WBC ≥ 3.0×10e9/L, Hb ≥80 g/L, PLT ≥ 50×10e9/L; * No serious allergic constitution; * No other serious diseases that conflicts with the clinical program; * No other cancer history; * No serious mental disorder; * Informed consent is signed by a subject or his lineal relation. Exclusion Criteria: * Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test); * Uncontrolled active infection, HIV infection, syphilis serology reaction positive; * Active hepatitis B or hepatitis C infection; * Recent or current use of glucocorticoid or other immunosuppressor; * With severe cardiac, liver, renal insufficiency, diabetes and other diseases; * Participate in other clinical research in the past three months; * previously treatment with any gene therapy products; * Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results.
Where this trial is running
Beijing, Beijing Municipality
- Liang Wang — Beijing, Beijing Municipality, China (Recruiting)
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.