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Relapsed or Refractory Acute Lymphoblastic LeukemiaPhase 1NCT03018093

A Phase I Study Evaluating Safety and Efficacy of C-CAR011 Treatment in Adult Subjects With r/r CD19+B-ALL

A Phase 1 study testing C-CAR-011 in people with Relapsed or Refractory Acute Lymphoblastic Leukemia, run by Shanghai AbelZeta Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The trial is a single arm, single-center, non-randomized phase I clinical trial which is designed to evaluate the safety and efficacy of C-CAR011 in treatment of adult subjects with relapsed/refractory CD19+ B cells acute lymphoblastic leukemia(r/r CD19+B-ALL) Read more about this study

Who is it for?
Ages 14 to 75 years
What is being tested?
C-CAR-011
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
Jan 2017to Nov 2018
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 14 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age 14-75 years old, male or female.
  • Volunteered to participate in this study and signed written informed consent form.
  • Histologically diagnosed as CD19+B-ALL according to the NCCN Acute Lymphoblastic Leukemia Clinical Practice Guidelines (2016 version 1).
  • Relapsed or refractory CD19+B-ALL (meet one of the following conditions)
  • Refractory as defined not achieving a CR(complete remission, morphology<5% blasts) after two cycles of standard chemotherapy regimen.
  • Duration of remission ≤ 12 months after the first induction chemotherapy regimen.
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  • Refractory disease after one or more salvage therapies.
  • Two or more Bone Marrow relapse.
  • Morphological disease in the bone marrow (≥ 5% blasts).
  • Subjects with Philadelphia chromosome negative(Ph-) disease, or subjects with Philadelphia chromosome positive(Ph+) disease that are intolerant to or have failed 2 lines of tyrosine kinase inhibitor therapy (TKI), or if TKI therapy is contraindicated are eligible.
  • No salvage chemotherapy therapy within 4 weeks prior to C-CAR011 therapy.
  • No immunosuppressant(including but not limited to systemic corticosteroid therapy) within 4 weeks prior to C-CAR011 therapy.
  • No antibody therapy within 4 weeks prior to C-CAR011 therapy.
  • Normal cardiac function confirmed by ECHO with left ventricular ejection fraction (LVEF) ≧ 50%, no evidence of pericardial effusion and clinically significant arrhythmias.
  • Baseline oxygen saturation ≧ 92% on room air and with normal pulmonary function, no evidence of active lung infection.
  • No contraindications of peripheral blood apheresis.
  • Expected survival ≧ 3 months.
  • Eastern cooperative oncology group (ECOG) performance status of 0 or 1.

Who cannot join

  • History of severe allergic disease or allergic to one or more drugs.
  • Any kind of these laboratory testing: serum total bilirubin≧1.5mg/dl, serum albumin≦35g/L, ALT, AST≧2.5×ULN, serum creatinine≧2.0mg/dl, platelets≦50×109/L.
  • Extramedullary disease.
  • Relapsed disease after allogeneic hematopoietic stem cell transplantation.
  • Diagnosis of Burkitt's leukemia/lymphoma according to WHO classification or chronic myelogenous leukemia lymphoid blast crisis.
  • Subjects with concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome or any other known bone marrow failure syndrome.
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  • Subjects with grade III or above severe hypertension(WHO/ISH Guidelines for the Management of Hypertension, 1999).
  • History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months prior to enrollment.
  • Subjects with class III and IV heart failure according to the NYHA Heart Failure Classifications;
  • History of QT prolongation with clinically significant arrhythmias.
  • History of epilepsy or other central nervous system disorders.
  • History or presence of any central nervous system leukemia(CNS3, CNS4) disorder , with insensitive to intrathecal injection of or radiotherapy of head/spine; but effectively controlled cases will be eligible.
  • Autoimmune diseases needing treatment, or immune deficiency or other diseases needing immunosuppressive therapy.
  • Subjects with TKIs therapy (Ph+ ALL) within 1 week prior to enrollment.
  • Severe active infection (uncomplicated urinary tract infections, bacterial pharyngitis allowed) or currently receiving intravenous antibiotic therapy and has received intravenous antibiotic therapy within one week. Prophylactic antibiotic, antiviral and antifungal treatment is permissible.
  • Used any genetically modified T cell therapy.
  • Presence of any indwelling line or drain (e.g., percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Ommaya reservoirs and dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted.
  • Live vaccine≦4 weeks prior to enrollment.
  • Known infection with HIV, TB, hepatitis B (including carriers) or hepatitis C virus (anti-HCV positive).
  • History of alcohol addiction , drug abuse or mental disease.
  • Participated in any other clinical trial within three months prior to enrollment.
  • Women who are pregnant or lactating or have breeding intent within 6 months.
  • The investigators believe that any increase in the risk of the subject or interference with the results of the trial.

Trial locations and contacts

1 site in 1 country.

Li Yu contact

010-66937644

liyu301@vip.163.com

China1 site, 1 recruiting

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality

    Li Yu, 010-66937644, liyu301@vip.163.com

    Recruiting

Other trials in China

About this study

Official title: A Phase I Study Evaluating Safety and Efficacy of CBM.CD19-targeted Chimeric Antigen Receptor T Cells (C-CAR011) Treatment in Adult Subjects With Relapsed/Refractory CD19+ B Cells Acute Lymphoblastic Leukemia(CALL-1)

The trial is a single arm, single-center, non-randomized phase I clinical trial which is designed to evaluate the safety and efficacy of C-CAR011 in treatment of adult subjects with relapsed/refractory CD19+ B cells acute lymphoblastic leukemia(r/r CD19+B-ALL)

Read the detailed description

This is a single-center, Open Label phase I clinical trial, 20 subjects planned to be enrolled. The trial have two stages (Phase I dose-escalation clinical trial and phase I dose expansion trial).Subjects will be divided into low-dose group, medium-dose group and high-dose group.Additional patients will be enrolled to confirm the optimal dose

Dose CAR+ cells/kg Low 0.5×106 Medium 1.5×106 High 3.0×106

Being tested
C-CAR-011
Keywords
Relapsed or refractory acute lymphoblastic leukemia, Anti-CD19 chimeric antigen receptor T-cell
Medical subject headings
Recurrence, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • C-CAR-011Biological

    Also called CAR-CD19

    CD19-targeted chimeric antigen receptor T cells

Study groups in NCT03018093
Study groupRoleWhat they receive
C-CAR011ExperimentalIn day 0, 1 and 2, CAR011 cells will be intravenous infused at the 10%, 30% and 60% ratio respectively.
Receives: Biological: C-CAR-011

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity (DLT)

    Measured: 30 days

Secondary outcomes (3)

  1. Overall response rate (ORR)

    Measured: 8 weeks

  2. Overall survival (OS)

    Measured: 24 weeks

  3. Minimal residual disease negative remission rate(MRD-)

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2017 (estimated)
  2. Study startJan 2017
  3. Primary completionAug 2018 (estimated)
  4. Study completionNov 2018 (estimated)

Resources

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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03018093
Sponsor's protocol ID
CBMG2016003
Status last verified
Jan 2017
First submitted
10 Jan 2017
Last updated
20 Jan 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing C-CAR-011 in people with Relapsed or Refractory Acute Lymphoblastic Leukemia, run by Shanghai AbelZeta Ltd. at 1 site in China.

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 18 inclusion and 23 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 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Li Yu (010-66937644, liyu301@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03018093.

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 20 Jan 2017.

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