CD22/CD19 CAR-T and Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL

Plain-language summary

CAR T-cell therapy has achieved remarkable results in B-cell acute lymphoblastic leukemia (B-ALL), but relapse afterwards remains a major problem, and multi-antigen CAR T approaches combined with other regimens may lower the relapse rate. In this Phase 2 study the investigators evaluate the safety and efficacy of a "sandwich" strategy that combines CD22/CD19 CAR T cells with autologous hematopoietic stem cell transplantation as consolidation therapy. Eligible patients have primary B-ALL with no suitable allogeneic transplant donor or who declined allogeneic transplant, and must show CD19 and CD22 expression by flow cytometry.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Active, not recruiting

Sponsor

The First Affiliated Hospital of Soochow University

Intervention

CD22/CD19 CAR T and auto-HSCT "sandwich" strategy

Start date

1/19/2020

Estimated completion

7/21/2039

Countries

China

Locations

• Suzhou, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* subjects with a primary diagnosis of B-ALL who have any of the following: (a) no suitable allogeneic HSCT donor. (b) refusal of allogeneic HSCT.
* positive expression of CD19 and CD22 in peripheral blood or bone marrow primary cells detected by flow cytometry.
* cardiac ultrasound left ventricular ejection fraction ≥ 50%; Creatinine ≤ 1.6 mg/dl; alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the normal range and total bilirubin ≤ 2.0 mg/dl; Pulmonary function ≤ grade 1 dyspnea (CTCAE v5.0) with oxygen saturation \> 91% without oxygenation.
* subjects aged 15-65 years (including 15 and 65 years), regardless of gender.
* T-cell amplification test pass.
* expected survival \> 3 months.

Exclusion Criteria:

* patients with recurrence of only isolated extramedullary lesions.
* combination of other malignant tumors.
* previously treated with anti-CD19 or/and CD22 or/and CD3 therapies.
* immunosuppressants use within 2 weeks prior to signing informed consent or plan to immunosuppressants after signing informed consent.
* uncontrolled active infections.
* HIV infection.
* active hepatitis B or hepatitis C infection.
* history of severe tachyphylaxis to aminoglycoside antibiotics.
* history or presence of clinically relevant Central Nervous System (CNS) pathology, such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.