Bispecific CAR-T cell therapy for relapsed B-cell cancers

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 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.

Why it matters

Who can join: the full rules

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 it's running

• Liang Wang
  Beijing, Beijing Municipality, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

  This early-phase trial tests a one-time in vivo CAR T-cell therapy (SL1617) for people with relapsed or refractory B-cell lymphoma to see if it is safe and tolerable.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07775508

• CLIC-2201 treatment for relapsed B cell cancers

  This study is testing a new CAR-T cell therapy called CLIC-2201 to see if it can help people with relapsed B cell cancers feel better and improve their treatment outcomes.

  Recruiting at 7 sites Phase 1 British Columbia Cancer Agency · Calgary, Alberta and 6 other locations · NCT06208735

• Using itacitinib to improve CAR T cell therapy outcomes in lymphoma patients

  This study is testing if taking itacitinib before and after CAR T cell therapy can help improve outcomes for lymphoma patients with high inflammation levels.

  Recruiting Phase 2 H. Lee Moffitt Cancer Center and Research Institute · Tampa, Florida · NCT05757219

• Local production of CAR T-cells for treating B-Cell cancers

  This study is testing whether making CAR T-cells locally can help patients with B-Cell lymphoma and leukemia have a safe and effective treatment.

  Recruiting Phase 2 Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Pittsburgh, Pennsylvania · NCT05281809

• CD19 and CD22 in vivo CAR-T therapy for relapsed/refractory B-ALL

  This study tests a one-of-a-kind in vivo CAR-T treatment that targets CD19 first and then CD22 in adults with relapsed or refractory B-ALL to see if it is safe and possibly effective.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07927816

• Umbilical Cord Blood CAR-T Cells Targeting CD19 and CD22 for relapsed/refractory B-ALL

  This phase 1 study tests whether dual-target cord blood-derived CAR-T cells against CD19 and CD22 are safe and tolerable in adults with relapsed or refractory B-cell ALL.

  Recruiting Phase 1 Ruijin Hospital · Shanghai, Shanghai Municipality · NCT07838714

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.