CD19/CD22-targeted Chimeric Antigen Receptor Engineered T Cell (CART) in B-Cell Acute Lymphoblastic Leukemia.

Conditions

Leukemia, B-cell

Keywords

CD19, CD22

Brief summary

This is a single center, open-label ,phase 1/2 study to evaluate the safety and efficacy of targeted CD19/CD22 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD19/CD22 positive Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

Detailed description

The patients will receive infusion of CART cells targeting CD19 and CD22 to confirm the safety and efficacy of CD19/CD22 CART Cells in Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

Ying Tang, Mengyun LI, Qingya Cui, Sining Liu, Zijian Li et al. (10 authors)

Journal of Translational Medicine2026-03-30

10.1186/s12967-026-07974-w

Which one is better for refractory/relapsed acute B-cell lymphoblastic leukemia: Single-target (CD19) or dual-target (tandem or sequential CD19/CD22) CAR T-cell therapy?

Liu S, Zhang X, Dai H, Cui W, Yin J, Li Z, Yang X, Yang C, Xue S, Qiu H, Miao M, Chen S, Jin Z, Fu C, Li C, Sun A, Han Y, Wang Y, Yu L, Wu D, Cui Q, Tang X.

2023-04-2428 citations

10.1038/s41408-023-00819-5

CAR-T cell therapy followed by allogenic hematopoietic stem cell transplantation yielded comparable outcome between Ph like ALL and other high-risk ALL.

Dai HP, Kong DQ, Shen HJ, Cui W, Wang Q, Li Z, Yin J, Kang LQ, Yu L, Wu DP, Tang XW.

2023-02-156 citations

10.1186/s40364-023-00451-2

Anti CD19 CART Therapy Following Allogenic Hematopoietic Stem Cell Transplantation Improved the Survival of Patients with <i> <i>BCR::ABL1</i> </i>-like Acute Lymphoblastic Leukemia

Haiping Dai, Wei Cui, Hongjie Shen, Qian Wang, Jia Yin et al. (8 authors)

Blood2022-11-15

10.1182/blood-2022-166687

Tandem CD19/CD22 Dual Targets CAR-T Cells Therapy Obtains Superior CR Rate Than Single CD19 CAR-T Cells Infusion As Well As Sequential CD19 and CD22 CAR-T Cells Infusion for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia Patients

Sining Liu, Xinyue Zhang, Haiping Dai, Qingya Cui, Wei Cui et al. (22 authors)

Blood2021-11-058 citations

10.1182/blood-2021-152927

Decitabine in Combination with Fludarabine and Cyclophosphamide As Lymphodepletion Regimen Followed By CD19/CD22 Bispecific Targeted CAR-T Therapy Significantly Improves Survival in Relapsed/Refractory B-ALL Patients: A Pilot Study

Yunju Ma, Changju Qu, Haiping Dai, Sining Liu, Qingya Cui et al. (14 authors)

Blood2021-11-051 citations

10.1182/blood-2021-152041

Interventions

BIOLOGICALCART-19/22

Split intravenous infusion of CART-19/22 cells of (Dose escalating infusion of 1 - 20 x10\^6 CART-19/22 cells/kg).

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 65 Years

Healthy volunteers

No

Inclusion criteria

* Male or female patients with CD19+/CD22+ relapsed/refractory B-cell acute lymphoblastic leukemia who have a dismal prognosis (estimated survival from several months to \<2 year). The study will enroll 20 evaluable patients as follows: * Age 6-65 years. * Left ventricular ejection fractions≥ 0.5 by echocardiography. * Creatinine \< 1.6 mg/dL. * Aspartate aminotransferase/aspartate aminotransferase \< 3x upper limit of normal. * Bilirubin \<2.0 mg/dL. * Karnofsky performance status ≥ 60 * Expected survival time ≥ 3 months (according to investigator's judgement)

Exclusion criteria

* Pregnant or lactating women. * Uncontrolled active infection. * Active hepatitis B or hepatitis C infection. * Class III/IV cardiovascular disability according to the New York Heart Association Classification. * HIV infection. * Patients with history of seizure * Active central nervous system leukemia

Design outcomes

Primary

Measure	Time frame	Description
Number of Adverse Events	12 months	Adverse events are evaluated with CTCAE V4.03

Countries

China

Contacts

Primary ContactXiaowen Tang, Ph.D.

tangxiaowen@suda.edu.cn(0086)51267781856

Backup ContactLei Yu, Ph.D.

ylyh188@163.com8613818629089

Outcome results

None listed