Health TrialsbyHealthPanel

SNC116 Therapy for Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia

ConditionB-cell Acute Lymphoblastic Leukemia
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Simnova Biotechnology Co.,Ltd.

About this trial

This study aims to evaluate the safety and pharmacokinetic profile of SNC116 in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years and ≤ 75 years, with no gender restrictions.

ECOG score 0 to 2.

Diagnosed with B-ALL through MICM (cytological morphology, immunology, cytogenetics, and molecular genetics), and tested positive for CD19 by flow cytometry or immunohistochemistry.

Early recurrence: Recurrence occurring within 12 months after the first complete remission;

Disqualifiers

Diagnosed with Burkitt leukemia/lymphoma or chronic myeloid leukemia with acute lymphocytic transformation according to the WHO classification.

Recurrence with isolated extramedullary lesions.

Within the previous 2 years, had a malignant tumor that required treatment or had evidence of recurrence (excluding: fully cured non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, superficial bladder cancer, breast duct carcinoma in situ, thyroid cancer, and other localized carcinomas).

Known to have any allergic, hypersensitive, intolerant or contraindicated reaction to any component of SNC116 or the drugs used in the study (such as tocilizumab), or has previously experienced a severe allergic reaction.

Trial design

Design model

Single group

Treatments tested in this trial

  • SNC116

    Drug

    Subjects will receive SNC116 injection per different dose level

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: SNC116Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety Evaluation: The incidence rates, type and severity of all adverse events

Time frame
with 3 months after infusion
2

Safety Evaluation: DLT

Time frame
with 28 days after infusion

Secondary outcomes

1

The overall response rate (ORR)

Time frame
up to 3 months post-infusion
2

Bone marrow minimal residual disease (MRD) negativity rates

Time frame
up to 3 months post-infusion
3

Duration of Response (DOR)

Time frame
The assessment period began at infusion and continued until the first occurrence of documented progression, initiation of new anti-leukemia treatment, loss to follow-up, or death, whichever came first, with an expected maximum of 15 years.
4

Event-free survival (EFS)

Time frame
The assessment period began at infusion and continued until the first occurrence of documented progression, initiation of new anti-leukemia treatment, loss to follow-up, or death, whichever came first, with an expected maximum of 15 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Simnova Biotechnology Co.,Ltd.

Lead sponsor

The First Hospital of Jilin University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: