Relapsed and/or Refractory CD33+ AMLPhase 1NCT02799680
Allogeneic CART-33 for Relapsed/Refractory CD33+ AML
A Phase 1 study testing allogeneic CART-33 in people with Relapsed and/or Refractory CD33+ AML, run by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences at 2 sites in China.
Trial summary
The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of differentiation 33 (CD33)-directed chimeric antigen receptor modified T cells (CART-33) infusions in patients with relapsed / refractory acute myeloid leukemia (AML). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Relapsed and/or Refractory CD33+ AML
- What is being tested?
- allogeneic CART-33
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesChina
- Study dates
- Oct 2015to May 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years
- Patient with relapsed and/or refractory CD33 positive acute myeloid leukemia (AML)
- Estimated life expectancy ≥ 12 weeks (according to investigator's judgment)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Who cannot join
- Previous treatment with investigational gene or cell therapy medicine products
- CD33 negative leukemia
- Any uncontrolled active medical disorder that would preclude participation as outlined
- Pregnant or lactating women
Trial locations and contacts
2 sites in 1 country.
Huisheng Ai, MD contact
China2 sites, 2 recruiting
- Recruiting
Affiliated Hospital of Academy of Military Medical Sciences
Beijing, Beijing Municipality, 100071
Huisheng Ai, MD, 86-1066947126, huishengai@163.com
Huisheng Ai, MD
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Weidong Han, MD, 86-13651392893, hanwdrsw@sina.com
Weidong Han, MD
About this study
Official title: Treatment of Relapsed and/or Refractory CD33-positive Acute Myeloid Leukemia by Infusions of Allogeneic CART-33
The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of differentiation 33 (CD33)-directed chimeric antigen receptor modified T cells (CART-33) infusions in patients with relapsed / refractory acute myeloid leukemia (AML).
Read the detailed description
The relapsed and/or refractory AML patients will receive infusions of allogeneic CART-33 within 1 week after chemotherapy. The re-induction chemotherapy regimen was primarily idarubicin and cytarabine, and no graft-versus-host disease (GVHD) prevention was conducted pre- and post- therapy.
- Conditions
- Relapsed and/or Refractory CD33+ AML
- Being tested
- allogeneic CART-33
- Keywords
- CART, AML
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogeneic CART-33Biological
allogeneic CD33-directed chimeric antigen receptor-modified T cells (CART-33)
| Study group | Role | What they receive |
|---|---|---|
| allogeneic CART-33 | Experimental | infusions of allogeneic CD33-directed chimeric antigen receptor-modified T cells (CART-33) Receives: Biological: allogeneic CART-33 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of study related adverse events
defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria
Measured: 1 year
Secondary outcomes (3)
Overall response rate of allogeneic CART-33
A response is defined as: (1) a morphologic complete remission (CR) or (2) a complete remission with incomplete recovery of counts (CRi) (based on NCCN guidelines (National Comprehensive Cancer Network (NCCN), 2015) or (3) a negative minimal residual disease assessed by flow cytometry or qPCR
Measured: up to 24 weeks
Disease-free survival
Measured: up to 24 weeks
Overall survival
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startOct 2015
- Primary completionMay 2017 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed and/or Refractory CD33+ AMLStudies 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Responsible party
- Sponsor
- Investigators
- Huisheng Ai, MD, Study chair, Affiliated Hospital of Academy of Military Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799680
- Sponsor's protocol ID
- CART-AML-2015
- Status last verified
- Jun 2016
- First submitted
- 7 Jun 2016
- Last updated
- 15 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Relapsed and/or Refractory CD33-positive Acute Myeloid Leukemia by Infusions of Allogeneic CART-33
- ClinicalTrials.gov ID
- NCT02799680
- Acronym / sponsor ID
- CART-AML-2015
- Conditions
- Relapsed and/or Refractory CD33+ AML
- Keywords
- CART, AML
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of the Chinese Academy of Military Medical SciencesUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Study start
- Oct 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 15 Jun 2016 (estimated)
- 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.
The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of differentiation 33 (CD33)-directed chimeric antigen receptor modified T cells (CART-33) infusions in patients with relapsed / refractory acute myeloid leukemia (AML).
Detailed description
The relapsed and/or refractory AML patients will receive infusions of allogeneic CART-33 within 1 week after chemotherapy. The re-induction chemotherapy regimen was primarily idarubicin and cytarabine, and no graft-versus-host disease (GVHD) prevention was conducted pre- and post- therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| allogeneic CART-33 | Experimental | Biological: allogeneic CART-33infusions of allogeneic CD33-directed chimeric antigen receptor-modified T cells (CART-33) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 50 years
- Patient with relapsed and/or refractory CD33 positive acute myeloid leukemia (AML)
- Estimated life expectancy ≥ 12 weeks (according to investigator's judgment)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Key exclusion criteria (4 listed)
- Previous treatment with investigational gene or cell therapy medicine products
- CD33 negative leukemia
- Any uncontrolled active medical disorder that would preclude participation as outlined
- Pregnant or lactating women
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 |
|---|---|---|
| allogeneic CART-33allogeneic CD33-directed chimeric antigen receptor-modified T cells (CART-33) | Biological | allogeneic CART-33 |
Primary outcome
Occurrence of study related adverse events
Time frame: 1 year
defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria
3 secondary outcomes
Overall response rate of allogeneic CART-33
Time frame: up to 24 weeks
Disease-free survival
Time frame: up to 24 weeks
Overall survival
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Relapsed and/or Refractory CD33+ AML
RecruitingPhase 1
CD33KO-HSPC Infusion Followed by CART-33 Infusion(s) for Refractory/Relapsed AML
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RecruitingPhase 1
Anti-CD33-CLL1 CAR-T Cells (ICG415) for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
Acute Myeloid Leukemia (AML)
RecruitingPhase 1/2
Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies
Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed/Refractory B-cell Non-Hodgkin Lymphoma or CLL/SLL
RecruitingPhase 1
CD33-CAR T Cell Therapy for the Treatment of Recurrent or Refractory Acute Myeloid Leukemia
Acute Myeloid Leukemia, Recurrent Adult Acute Myeloid Leukemia
Active, not recruitingPhase 1
SENTI-202: Off-the-shelf Logic Gated CAR NK Cell Therapy in Adults With CD33 and/or FLT3 Blood Cancers Including AML/MDS
AML/MDS, CD33 Expressing Hematological Malignancies
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.
Huisheng Ai, MD contact
Huisheng Ai, MD study chair
Affiliated Hospital of Academy of Military Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing allogeneic CART-33 in people with Relapsed and/or Refractory CD33+ AML, run by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences at 2 sites 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 4 inclusion and 4 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 15 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Huisheng Ai, MD (861066947135), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of study related adverse events (time frame: 1 year). 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 15 Jun 2016.