A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Allogeneic Anti CD19 CAR-T Bridging to Hematopoietic Stem Cell Transplantation in Patients With Refractory or Relapsed B Cell Acute Lymphoblastic Leukemia

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is a phase 1, open-label study to assess the efficacy, safety and pharmacokinetics of ThisCART19A (Allogeneic Anti CD19 CAR-T) bridging to HSCT in patients with refractory or relapsed B cell acute lymphoblastic leukemia (r/r B-ALL).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 65
Healthy Volunteers: f
View:

• Voluntarily sign a documented IRB-approved ICF prior to any screening procedure.

• No gender limitation, 14 years ≤ age ≤ 65 years.

• Intention to HSCT therapy.

• Meeting the diagnostic criteria of relapsed or refractory B-ALL. Relapsed B-ALL: Reappearance of blasts in the blood or bone marrow (\>5%) or in any extramedullary site after a CR. Refractory B-ALL: Failure to achieve CR or CRi at the end of induction therapy (General refers to a 4-week regimen or a Hyper-CVAD regimen); Subjects with Ph+ disease are eligible if they are intolerant to TKI therapy, or if they have relapsed/refractory disease despite treatment with at least 2 different TKIs.

• Life expectancy ≥ 8 weeks at the time of enrollment.

• Eastern Cooperative Oncology Group performance status score of 0 or 1.

• Adequate bone marrow, renal, hepatic, pulmonary and cardiac function:

‣ Adequate marrow function for lymphodepletion chemotherapy assessed by the investigator.

⁃ Creatinine clearance \> 30 mL/min according to the Cockcroft-Gault formula;

⁃ ALT and AST ≤ 5 × ULN (the upper limit of normal), total bilirubin ≤ 2×ULN. (Subjects with Gilbert syndrome or liver involvement may be included if their total bilirubin is ≤ 3 × ULN.)

⁃ Oxygen saturation (SaO2) ≥ 92% on room air.

⁃ Cardiac function:left ventricular ejection fraction (LVEF) ≥ 40% assessed by echocardiography.

• CD19-positive leukemia obtained from bone marrow or peripheral blood confirmed by flowcytometry or biopsy during screening.

Locations
Other Locations
China
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Contact Information
Primary
Jia Chen, M.D., Ph.D.
drchenjia@163.com
+86-512-67781856
Backup
Jun Li, Ph.D.
jli@ctigen.com
+86-18662604088
Time Frame
Start Date: 2022-12-01
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 20
Treatments
Experimental: Treatment
In this study, allogeneic anti-CD19 CAR T cells (ThisCART19A) infusion is used as a bridge therapy to hematopoietic stem cell transplantation to treat patients with refractory or relapsed CD19 positive B cell acute lymphoblastic leukemia. Lymphodepletion conditioning before CAR T cell infusion consists of fludarabine, CTX and VP-16.
Sponsors
Leads: The First Affiliated Hospital of Soochow University
Collaborators: Fundamenta Therapeutics, Ltd.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials