Treatment using CD19 and CD22 targeted CAR-T cells for relapsed B-ALL

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 research evaluates the safety and efficacy of a novel therapy using CD19 and CD22 targeted prime CAR-T cells in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL). The study aims to address the limitations of existing anti-CD19 CAR-T therapies, particularly for patients who have either not responded to these treatments or have experienced CD19 negative relapses. By focusing on dual targeting, the study seeks to improve treatment outcomes for this challenging patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Signed written informed consent
2. Diagnose as Relapsed and Refractory B -ALL, and meet one of the following conditions:

   1. Failed to standard chemotherapy regimens;
   2. Relapse after complete remission, high-risk and / or refractory patients ;
   3. Relapse after hematopoietic stem cell transplantation;
3. For patients with Ph + ALL, the following conditions must be met: those who have received a standard induction chemotherapy regimen and who have not achieved complete remission after TKI treatment or have relapsed after remission (cannot tolerate TKI treatment or have contraindications to TKI treatment or the presence of TKI class) Except for drug resistant patients)
4. Evidence for cell membrane CD19 or CD22 expression
5. All genders ages: 2 to 75 years
6. The expect time of survive is above 3 months;
7. KPS\>60
8. No serious mental disorders ;
9. Left ventricular ejection fraction ≥50%
10. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
11. Sufficient renal function defined by creatinine clearance≤2 x ULN;
12. Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
13. With single or venous blood collection standards, and no other cell collection contraindications;
14. Ability and willingness to adhere to the study visit schedule and all protocol requirements.

Exclusion Criteria:

1. Previous history of other malignancy;
2. Presence of uncontrolled active infection;
3. Evidence of disorder that need the treatment by glucocorticoids;
4. Active or chronic GVHD
5. The patients treatment by inhibitor of T cell
6. Pregnant or breasting-feeding women;
7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.

Where it's running

• 920th Hospital of Joint Logistics Support Force
  Kunming, Yunnan, China Recruiting

Study contacts

• Principal investigator: Sanbin Wang, MD — 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
• Study coordinator: Zhi Yang, PhD
• Email: yangzhi@precision-biotech.com
• Phone: 86-13206140093

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

• CD19 CAR-T versus donor lymphocyte infusion for clearing MRD after allogeneic stem cell transplant in Ph-negative B-ALL

  This trial tests whether a single infusion of autologous CD19 CAR-T cells or chemotherapy plus donor lymphocyte infusion better clears minimal residual disease in patients aged 3–79 with Ph-negative B‑cell ALL after allogeneic stem cell transplant.

  Recruiting Phase 3 Peking University People's Hospital · Beijing, China · NCT07441291

• Using CD22 CAR T-cells to extend remission after commercial CD19 CAR T-cell therapy in children, adolescents, and adults with relapsed/refractory B‑ALL

  This will try giving CD22-targeted CAR T-cells to people aged 3–65 who are in remission after CD19 CAR T-cell therapy to see if it helps keep their B-ALL from coming back longer.

  Recruiting Phase 2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07328503

• Senl_B19 (S1904) CD19 CAR-T for relapsed or refractory CD19+ B-ALL in children and young adults

  This trial will test S1904 (Senl_B19) CD19 CAR-T cells in children and young adults aged 3–25 with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia.

  Recruiting Phase 2 Hebei Senlang Biotechnology Inc., Ltd. · Beijing · NCT07244406

• CD5 CAR T-cell therapy for relapsed or refractory T-cell lymphoma

  This trial tries CD5 CAR T-cell therapy, using either the patient's own cells or donor cells, and may bridge to stem-cell transplant for people 14–70 with relapsed or refractory T-cell lymphoma.

  Recruiting at 3 sites Phase 1/2 Beijing GoBroad Hospital · Beijing and 2 other locations · NCT07022964

• Glofitamab plus obinutuzumab for mantle cell lymphoma after CAR‑T

  This trial tests whether the antibody drug glofitamab given with obinutuzumab can shrink or control mantle cell lymphoma that returned or didn't respond after CD19 CAR‑T therapy in adults.

  Recruiting at 11 sites Phase 2 National Cancer Institute (NCI) · Duarte, California and 10 other locations · NCT07003295

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.