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
Qualifiers
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
Treatments tested in this trial
- KSV01 Injection
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Zhejiang University
Lead sponsor
TCRx Therapeutics Co.Ltd
Collaborator
Source ClinicalTrials.gov