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Trial Title:
ThisCART19A Bridging to alloHSCT for R/R B-ALL
NCT ID:
NCT05679687
Condition:
CAR
Refractory Acute Lymphoblastic Leukemia
Relapsed Adult ALL
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Conditions: Keywords:
Universal CAR-T
allogeneic HCT
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Treatment
Description:
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.
Arm group label:
Treatment
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).
Detailed description:
This is a phase 1, single-center, nonrandomized, open-label, dose-escalation study to
evaluate the efficacy, safety and pharmacokinetics of ThisCART19A bridging to HSCT in
patients with CD19 positive r/r B-ALL and identify a treatment regimen most likely to
result in clinical efficacy while maintaining a favorable safety profile. Before
initiating ThisCART19A infusion, subjects will be administered lymphodepletion
chemotherapy composed of fludarabine、cyclophosphamide and VP-16. At Day 0 of the
Treatment Period, subjects will receive an intravenous (IV) infusion of ThisCART19A. All
subjects are monitored during the treatment period through Day 28. All subjects who
receive a dose of ThisCART19A will be followed up to 2 years.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntarily sign a documented IRB-approved ICF prior to any screening procedure.
2. No gender limitation, 14 years ≤ age ≤ 65 years.
3. Intention to HSCT therapy.
4. 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.
5. Life expectancy ≥ 8 weeks at the time of enrollment.
6. Eastern Cooperative Oncology Group performance status score of 0 or 1.
7. Adequate bone marrow, renal, hepatic, pulmonary and cardiac function:
1. Adequate marrow function for lymphodepletion chemotherapy assessed by the
investigator.
2. Creatinine clearance > 30 mL/min according to the Cockcroft-Gault formula;
3. 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.)
4. Oxygen saturation (SaO2) ≥ 92% on room air.
5. Cardiac function:left ventricular ejection fraction (LVEF) ≥ 40% assessed by
echocardiography.
8. CD19-positive leukemia obtained from bone marrow or peripheral blood confirmed by
flowcytometry or biopsy during screening.
Exclusion Criteria:
1. Allergic to preconditioning measures.
2. History of allogeneic HSCT.
3. Other malignancies apart from B-cell malignancies within 5 years prior to screening.
(Subjects with cured skin squamous carcinoma, basal cell carcinoma, non-primary
invasive bladder cancer, localized low-risk prostate cancer, in situ cervical/breast
cancer can be enrolled.)
4. Severe active infection. (Simple urinary tract infection (UTI) and uncomplicated
bacterial pharyngitis are permitted.)
5. Pulmonary embolism within 3 months prior to enrollment.
6. Severe cardiovascular and cerebrovascular diseases and hereditary diseases
intolerant to CAR-T therapy assessed by the investigator prior to enrollment.
7. Presence of symptomatic CNS involvement (both primary and secondary) at screening
confirmed by imaging;
8. Active hepatitis B virus (defined as serum HBV-DNA ≥ 2000 IU/mL), hepatitis C virus
(HCV), human immunodeficiency virus (HIV) or active syphilis infection prior to
enrollment. (Subjects with HBV-DNA < 2000 IU/mL can be enrolled, but should be
administered antiviral drugs such as entecavir and tenofovir with relative clinical
indicators monitored simultaneously during the treatment.)
9. Vaccinated with influenza vaccine within 2 weeks prior to lymphodepletion
chemotherapy. (Subjects vaccinated with SARS-COV19 vaccine or inactivated,
live/non-live adjuvant vaccines can be enrolled.)
10. Female subjects who are pregnant, breastfeeding or planning for pregnancy within 1
year after CAR-T cell infusion, or male subjects whose partners are planning for
pregnancy within 1 year after CAR-T cell infusion.
11. Any conditions that would, in the investigator's assessment, increase risks in
patients or interfere with the outcomes of the trial.
Gender:
All
Minimum age:
14 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215000
Country:
China
Status:
Recruiting
Contact:
Last name:
Depei Wu
Phone:
+86 13951102021
Email:
drwudepei@163.com
Start date:
December 1, 2022
Completion date:
November 30, 2025
Lead sponsor:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Collaborator:
Agency:
Fundamenta Therapeutics, Ltd.
Agency class:
Industry
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05679687