KSV01 Injection as the Therapy for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
ConditionB-ALL
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorZhejiang University
About this trial
This is a single center, single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability and preliminary efficacy of KSV01 injection for patients with relapsed/refractory B-Cell acute lymphoblastic leukemia (r/r B-ALL).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntary participation and provision of written informed consent by the patient or their legally authorized representative.
Aged 18 to 80 years (inclusive), any gender.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
Life expectancy > 3 months.
Disqualifiers
Diagnosis of Burkitt's leukemia/lymphoma according to WHO 2016, or chronic myeloid leukemia in accelerated or blast phase.
History of another primary malignancy that has not been in continuous remission for at least 2 years. Exceptions to the 2-year limit include: non-melanoma skin cancer, curatively treated Stage I solid tumor with low risk of recurrence, cured carcinoma in situ of the cervix (biopsy-confirmed) or squamous intraepithelial lesion on Pap smear, and cured localized prostate cancer.
Uncontrolled active infection within 4 weeks prior to enrollment.
Active hepatitis B or hepatitis C virus infection.
Trial design
Design model
Single group
Treatments tested in this trial
KSV01 Injection
DrugKSV01 Injection is one kind of third-generation non-replicative self-inactivating lentivirus vector.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: KSV01 InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose-limiting Toxicity
DLT evaluation period: The DLT evaluation period is defined as within 28 days (inclusive) after the subjects' first administration of KSV01 injection during the dose escalation stage. All adverse events should be graded and evaluated in accordance with CTCAE v6.0. Among them, cytokine release syndrome (CRS) and immune effector cell-related neurotoxicity syndrome (ICANS) should be determined and graded in accordance with the standards of the American Society for Transplantation and Cell Therapy (ASTCT).
Time frame
28 days after administrationSponsors and contacts
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Zhejiang University
Lead sponsor
TCRx Therapeutics Co.Ltd
Collaborator
Source ClinicalTrials.gov