Relapsed or Refractory B-cell LymphomaPhase 1A-319NCT04056975
Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma
A Phase 1 study testing Recombinant Anti-CD19m-CD3 Antibody Injection in people with Relapsed or Refractory B-cell Lymphoma, run by EVIVE Biotechnology.
Trial summary
Title: A Phase I, Single Centre, Open-label, Dose-escalation Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed or Refractory B-cell Lymphoma
- What is being tested?
- Recombinant Anti-CD19m-CD3 Antibody Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2019to 27 Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years, all genders
- Patients with definite B-cell Lymphoma, includes FL, MZL, MCL, DLBCL.
- Patients With Relapsed or Refractory B-cell Lymphoma
- ECOG ≤ 2
- Lesions are measurable in 21 days before treatment
- Normal bone marrow function
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- Normal liver, kidney, lung and heart function
- the Subjects can sign the ICF and obey the protocol, elsewise, his/her guardian should sign
- Life expectancy is at least 3 months
Who cannot join
- Associated with lymphoma by the infiltrates of CNS
- A history of autoimmune disease with CNS involvement or autoimmune disease
- Previous history of autoimmune disease or other malignancy
- A history of deep venous thrombosis or pulmonary embolism
- Auto-HSCT was performed within 12 weeks prior to initiation of treatment
- Previous organ transplantation or allogeneic hematopoietic stem cell transplantation
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- The Investigator determined that the patients were associated with a disease, medical condition, or social factor that might affect study results or compliance
- Immunosuppressant are being used
- Radiotherapy was given within 6 weeks prior to A-319 treatment
- Chemotherapy, immunotherapy and targeted therapy were received within 4 weeks before A-319 treatment
- Previous CAR-T cell therapy
- Received anti-lymphoma drugs in the first 4 weeks of A-319 treatment
- There was no recovery of toxic effects (CTCAE> grade 1 adverse events) at the last treatment, except hair loss
- Those who underwent major surgery 28 days before enrollment (excluding lymph node biopsy);Or plan to operate during the study period
- Those who had received active/attenuated live vaccine within 28 days prior to screening
- For pregnant (positive pregnancy test) and lactating women, those of childbearing age who signed the informed consent form and did not agree to use contraception for at least 3 months after the end of the study;Within 7 days prior to the first day of treatment, women of childbearing age require a positive serum pregnancy test (HCG)
- Male patients who signed informed consent forms and did not agree to use contraception for at least 3 months at the end of the study (except surgical sterilization)
- Known allergy to immunoglobulin or research drugs and their excipients
- Patients considered unfit to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase I, Single Centre, Open-label, Dose-escalation Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma
Title: A Phase I, Single Centre, Open-label, Dose-escalation Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma
Read the detailed description
Protocol Number: SP071744 Study Stage: Phase I Study Number: 1 site Subject Number: up to 54 patients with Relapsed or Refractory B-cell Lymphoma
- Conditions
- Relapsed or Refractory B-cell Lymphoma
- Being tested
- Recombinant Anti-CD19m-CD3 Antibody Injection
- Medical subject headings
- Recurrence, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Anti-CD19m-CD3 Antibody InjectionBiological
Intravenous Infusion
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | A-319 dosage: 0.05, 0.15, 0.03, 0.06, 0.12, 0.18, 0.24 μg/kg Receives: Biological: Recombinant Anti-CD19m-CD3 Antibody Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the Incidence and Characteristics of SAE of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
Incidence and Characteristics of SAE
Measured: At the end of Cycle 1 (each cycle is 28 days)
Evaluate the MTD and DLT of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
dose limited toxicity(DLT), maximum tolerance dose(MTD)
Measured: At the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes (7)
Evaluate the PK(Cmax) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
Peak Plasma Concentration(Cmax)
Measured: At the end of Cycle3 (each cycle is 28 days)
Evaluate the PK(AUC) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
Area under the plasma concentration versus time curve(AUC)
Measured: At the end of Cycle3 (each cycle is 28 days)
Evaluate the PK(Tmax) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
time to peak (Tmax)
Measured: At the end of Cycle3 (each cycle is 28 days)
Evaluate the PK(T1/2) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
half-life time(T1/2)
Measured: At the end of Cycle3 (each cycle is 28 days)
Evaluate the PK(CL) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
clearance(CL)
Measured: At the end of Cycle3 (each cycle is 28 days)
Evaluate the PK(Vz) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
volume of distribution(Vz)
Measured: At the end of Cycle3 (each cycle is 28 days)
Evaluate the PD of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
B-cell level
Measured: At the end of Cycle3 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start15 Sep 2019 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion27 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory B-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EVIVE Biotechnology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University Cancer Hospital & Institute
- Responsible party
- Sponsor
- Investigators
- Song Yuqin, Doctor, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056975
- Sponsor's protocol ID
- SP071744
- Acronym
- A-319
- Status last verified
- Aug 2019
- First submitted
- 8 Jul 2019
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Centre, Open-label, Dose-escalation Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT04056975
- Acronym / sponsor ID
- A-319 / SP071744
- Conditions
- Relapsed or Refractory B-cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- EVIVE BiotechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Peking University Cancer Hospital & Institute
- Study start
- 15 Sep 2019 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 27 Jan 2022 (estimated)
- First posted
- 14 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Title: A Phase I, Single Centre, Open-label, Dose-escalation Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma
Detailed description
Protocol Number: SP071744 Study Stage: Phase I Study Number: 1 site Subject Number: up to 54 patients with Relapsed or Refractory B-cell Lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Biological: Recombinant Anti-CD19m-CD3 Antibody InjectionA-319 dosage: 0.05, 0.15, 0.03, 0.06, 0.12, 0.18, 0.24 μg/kg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18-75 years, all genders
- Patients with definite B-cell Lymphoma, includes FL, MZL, MCL, DLBCL.
- Patients With Relapsed or Refractory B-cell Lymphoma
- ECOG ≤ 2
- Lesions are measurable in 21 days before treatment
Key exclusion criteria (19 listed)
- Associated with lymphoma by the infiltrates of CNS
- A history of autoimmune disease with CNS involvement or autoimmune disease
- Previous history of autoimmune disease or other malignancy
- A history of deep venous thrombosis or pulmonary embolism
- Auto-HSCT was performed within 12 weeks prior to initiation of treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Anti-CD19m-CD3 Antibody InjectionIntravenous Infusion | Biological | single arm |
Primary outcome
Evaluate the Incidence and Characteristics of SAE of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Incidence and Characteristics of SAE
Evaluate the MTD and DLT of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
Time frame: At the end of Cycle 1 (each cycle is 28 days)
dose limited toxicity(DLT), maximum tolerance dose(MTD)
7 secondary outcomes
Evaluate the PK(Cmax) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
Time frame: At the end of Cycle3 (each cycle is 28 days)
Evaluate the PK(AUC) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
Time frame: At the end of Cycle3 (each cycle is 28 days)
Evaluate the PK(Tmax) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
Time frame: At the end of Cycle3 (each cycle is 28 days)
Evaluate the PK(T1/2) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
Time frame: At the end of Cycle3 (each cycle is 28 days)
Evaluate the PK(CL) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
Time frame: At the end of Cycle3 (each cycle is 28 days)
Evaluate the PK(Vz) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
Time frame: At the end of Cycle3 (each cycle is 28 days)
Evaluate the PD of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
Time frame: At the end of Cycle3 (each cycle is 28 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Individual participant dataSharing planned: Yes. all IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Song Yuqin, Doctor principal investigator
Peking University Cancer Hospital & Institute
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant Anti-CD19m-CD3 Antibody Injection in people with Relapsed or Refractory B-cell Lymphoma, run by EVIVE Biotechnology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Jing, Bachelor (8613524953174, yangj@generonbiomed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the Incidence and Characteristics of SAE of A-319 Treat on Relapsed or Refractory B-cell Lymphoma (time frame: At the end of Cycle 1 (each cycle is 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.