Acute Myeloid LeukemiaPhase 2ACHIEVENCT05358808
ACHIEVE - Efficacy and Effectiveness of Adoptive Cellular tHerapy wIth Ex-Vivo Expanded Allogeneic γδ T-lymphocytes (TCB008) for Patients With Refractory or Relapsed Acute Myeloid Leukaemia (AML)
A Phase 2 study testing TCB008 in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by TC Biopharm at 6 sites in United Kingdom.
Trial summary
This is an open-label, phase II study designed to evaluate the efficacy and effectiveness of TCB008 in patients with Acute Myeloid Leukemia (AML), or Myelodysplastic Syndromes (MDS)/AML, with either refractory or relapsed disease. Five patients will be recruited for an initial safety cohort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- What is being tested?
- TCB008
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 15 Aug 2022to 30 Jul 2025
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 at the time of consent
- Karnofsky performance status ≥ 70% and WHO/ECOG performance status 0 -1 at enrolment and up to 2 at the time of infusion.
- Must be able to remain free of systemic corticosteroid (e.g., prednisolone) and other immunosuppressive therapy at screening and for at least 5 days prior to the infusion of γδ T cells. Maintenance replacement steroid after assessment of the primary endpoint is permitted.
- Must be able to understand and sign written informed consent and willing to participate in a clinical trial for an advanced therapy investigational medicinal product (AT(I)MP).
- For women of childbearing potential, a urine or serum pregnancy test will be performed within 7 days prior to initiating lymphodepletion. A serum pregnancy test will be performed on the day prior to the first infusion of TCB008 (i.e. day -1) and urine or serum pregnancy tests will be performed on the day of subsequent infusions with TCB008 and the results must be negative at all times that these pregnancy tests are performed. For women of childbearing potential, a serum pregnancy test will be performed at visit 17 or early termination. Patient and his/her partner must agree to use adequate contraception from the time of providing written consent through 3 months after the last study drug dose
- Pathologically confirmed diagnosis of AML or MDS/AML confirmed according to ELN 2022 Criteria (as per International Consensus Classification of AML).
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- For Cohort A1, patients must have AML or MDS/AML that is primary refractory defined as not achieving a CR, CRi or CRh after 2 cycles of intensive or non-intensive induction chemotherapy.
- For Cohort A2, patients with AML or MDS/AML must have previously achieved a CR, CRi or CRh (including MRD negative CR) to previous intensive or non-intensive therapy, then have experienced relapsed AML.
- For Cohort B, patients with AML who have achieved CR, CRi or CRh but have persistent MRD by multiparameter flow cytometry-based MRD (MFC-MRD) or molecular MRD (Mol-MRD) assessed by qPCR.
- Included patients will not be deprived of standard of care by participating in this trial.
Who cannot join
- Suspected or proven active CNS disease.
- Previous reactions to Fludarabine or Cyclophosphamide or patients at risk of Fludarabine related neurotoxicity
- Acute promyelocytic leukaemia
- Bisphosphonates (≤8 weeks before study entry), unless continued as a standard of care medication
- Corticosteroids (cumulative dose of systemic steroids >20mg of prednisolone per day or equivalent) that cannot be discontinued 5 days prior to TCB008 infusion.
- Antihyperlipidemic medications (e.g., statins) that cannot be discontinued prior to enrolment.
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- Cardiac failure: EF < 40%.
- Kidney function: creatinine clearance ≤ 60 mL/min.
- Liver function: total bilirubin > 3 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 5 × ULN.
- Neurological condition(s) which might be exacerbated by therapy or prevent assessments for neurotoxicity/ICANS.
- GVHD of any grade or anti-GVHD treatment.
- Lung function: symptoms of respiratory failure or < 92% oxygen saturation on air.
- Active infections that are difficult to control, including positive COVID-19 diagnosis at screening. NOTE: Active infections following lymphodepletion may exclude a patient from being able to be dosed with IMP.
- Received autologous or allogeneic cell therapy within 4 weeks, such as donor lymphocyte infusion.
- Received autologous or allogeneic gene modified adoptive cell therapy (e.g. CAR-T, TCR-T, CAR-NK cell therapy, etc).
- Subject received anti-tumour treatment (chemotherapy, monoclonal antibody, or hormone) within one week of screening (hydroxycarbamide is permitted until lymphodepletion).
- Has a known history of prior malignancy, except for;
- 17.a. Malignancies that were treated curatively and have not recurred within 2 years prior to study treatment 17.b. Completely resected basal cell and squamous cell skin cancers 17.c. Any malignancy considered to be indolent and that has never required therapy 17.d. Completely resected carcinoma in situ of any type
- 18. Pregnant or lactating women.
- 19. Hypersensitivity to iron-dextran or murine antibodies.
- 20. Patients who are active participants in other interventional clinical trials at the same time. Co-enrolment is permitted for non-interventional studies if approved by the CI.
- 21. The Investigator believes that there are other factors that are not suitable for inclusion or influence the patient's participation or completion of the study.
- 22. Considered unsuitable for further intensive therapy or expected to survive less than 3 months with conventional available treatments.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Bristol and Weston NHS foundation trust
Bristol, BS2 8ED
Cardiff and Vale University LHB
Cardiff, CF14 4HH
Queen Elizabeth University Hospital
Glasgow, G51 4TF
Guys&St Thomas NHS foundation Trust
London, SE1 7EH
Kings College Hospital
London, SE5 9RS
Royal Marsden Hospital
London, SW3 6JJ
About this study
Official title: ACHIEVE - An Adaptive Trial of the Efficacy and Effectiveness of Adoptive Cellular tHerapy wIth Ex-Vivo Expanded Allogeneic γδ T-lymphocytes (TCB008) for Patients With Refractory or Relapsed Acute Myeloid Leukaemia (AML)
This is an open-label, phase II study designed to evaluate the efficacy and effectiveness of TCB008 in patients with Acute Myeloid Leukemia (AML), or Myelodysplastic Syndromes (MDS)/AML, with either refractory or relapsed disease.
Five patients will be recruited for an initial safety cohort. The safety cohort will be followed by a two-stage Simon's Design, where a further 48 patients will be recruited into one of two cohorts and dosed with TCB008.
Read the detailed description
TCB008-001 (ACHIEVE) is an open-label, phase II study designed to evaluate the efficacy and effectiveness of TCB008 in patients with Acute Myeloid Leukemia (AML), or Myelodysplastic Syndromes (MDS)/AML, with either refractory or relapsed disease.
TCB008 is derived from the peripheral blood mononuclear cells (PBMCs) of unrelated, healthy donors and consists of expanded cluster designation (CD)3+ T cells expressing the γ-chain variable region 9 δ-chain variable region 2 (Vγ9Vδ2) T cell receptor (TCR); it is infused into patients to boost their immune system. It is currently developed for treatment of cancers and infectious diseases.
53 patients will take part in this study; five patients in an initial safety cohort followed by a two-stage Simon's Design that will recruit a further 48 patients into one of two patient cohorts.
Patients will be screened to assess their eligibility to enter the study 35 days prior to the first dose of the investigational medicinal product (IMP). Once enrolled in the study, patients will undergo lymphodepletion chemotherapy prior to administration of the IMP using the following regimen: fludarabine (30mg/m2/day) will be administered from days -6 to -3 (total 120mg/m2), and cyclophosphamide (0.5g/m2/day) from days -5 to -3 (total 1.5g/m2). No chemotherapy will be administered on days -2 and -1.
Cohort A will recruit patients with relapsed or refractory AML or MDS/AML. These patients will be split between one of two sub-cohorts;
- Cohort A1 will include patients with primary refractory AML or MDS/AML who have not achieved a CR, CRi, or CRh after two cycles of induction chemotherapy.
- Cohort A2 will include patients with AML or MDS/AML who have relapsed after initially achieving a CR, CRi, or CRh to previous chemotherapy.
This cohort would include MDS/AML patients with 10 to 19% blast levels in the bone marrow or peripheral blood as defined in the European Leukemia Net 2022 Criteria (as per international consensus classification of AML).
Cohort B will recruit patients with AML or MDS/AML who have achieved CR, CRi, or CRh but have a detectable measurable residual disease by MFC-MFD or Mol-RD by qPCR.
Patients may receive repeat infusions of TCB008, on up to three occasions, 14 days after the previous infusion. Re-infusions will not be preceded by lymphodepleting chemotherapy.
Patients will be followed for up to 52 weeks following the first infusion of TCB008, or until either; they are lost to follow-up, or early termination. Blood and bone marrow samples will be taken pre- and post-infusion to evaluate the study objectives and endpoints.
The total duration of study participation for each patient, from screening through to the end of study visit, is anticipated to be approximately 15 months.
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Being tested
- TCB008
- Keywords
- AML, MDS, MDS/AML, AML/MDS
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCB008Drug
Also called CD3+ T cells expressing the γ-chain variable region 9 δ-chain variable region 2 (Vγ9Vδ2) T cell receptor (TCR)
TCB008 is derived from the peripheral blood mononuclear cells (PBMCs) of unrelated, healthy donors and consists of expanded cluster designation (CD)3+ T cells expressing the γ chain variable region 9 δ-chain variable region 2 (Vγ9Vδ2) T cell receptor (TCR); it is infused into patients to boost their immune system. It is currently developed for treatment of cancers and infectious diseases.
| Study group | Role | What they receive |
|---|---|---|
| γδ T cells (IMP, TCB008) | Experimental | After inclusion, all patients will receive lymphodepleting chemotherapy with fludarabine 30mg/m2 Day -6 to Day -3 [total 120 mg/m2] and cyclophosphamide 0.5g/m2 [total 1.5 g/m2) Day -5 to Day -3,]. This will be followed by a rest day (Day -2).
The first five patients (safety cohort) will receive 1.8mL of TCB008 (containing 3.5x10^7 to 11.0x10^7 cells) on Day 0.
After treatment of the first five safety patients, the remaining 48 patients will receive 5mL of TCB008 (containing 12.0x10^7 to 23.0x10^7 cells) on Day 0. Receives: Drug: TCB008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in myeloblast levels in response to TCB008 dosing
Reduction in myeloblast levels compared to baseline, measured according to the ELN AML 2022 Response Criteria.
Measured: The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 15 months).
Patient relapse and subsequent response to repeat TCB008 dosing
Measured by the numbers of patients who, after initial response, subsequently relapse and then respond to an additional infusion.
Measured: The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 15 months).
Overall response rate to TCB008 dosing
Overall response rate, defined as morphological CR, CRi, Rh, PR, and MLFS at 28-days post-infusion, measured according to the ELN AML 2022 Response Criteria.
Measured: The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 15 months).
Measurable Residual Disease in response to TCB008 dosing
MRD-negative remission (CR without MRD or CR MRD-) by multiparameter flow cytometry-based MRD (MFC-MRD) or molecular MRD (Mol-MRD) assessed by qPCR, according to the ELN AML 2022 Response Criteria.
Measured: The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 15 months).
Secondary outcomes (6)
Severity of adverse events in response to TCB008 dosing
Safety assessment of AEs graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 15 months).
Incidence and severity of CRS and neurotoxicity in response to TCB008 dosing
Incidence and severity of cytokine release syndrome (CRS) and neurotoxicity, using the ASTCT consensus grading system.
Measured: The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 15 months).
Overall survival rates following TCB008 dosing
Overall survival assessed at 52 weeks according to the ELN AML 2022 Response Criteria.
Measured: The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 15 months).
Relapse-free survival following TCB008 dosing
Relapse-free survival assessed at 52 weeks according to the ELN AML 2022 Response Criteria.
Measured: The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 15 months).
Event-free survival following TCB008 dosing
Event-free survival assessed at 52 weeks according to the ELN AML 2022 Response Criteria.
Measured: The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 15 months).
Cumulative incidence of relapse following TCB008 dosing
Cumulative incidence of relapse assessed at 52 weeks according to the ELN AML 2022 Response Criteria.
Measured: The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 15 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start15 Aug 2022
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Why it stopped: The Trial was early terminated due to deficiencies in the Achieve Protocol: V8.0 dated 19 January 2024.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Biopharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emma Nicholson, MD, Principal investigator, Royal Marsden Hospital London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358808
- Sponsor's protocol ID
- TCB008-001
- Acronym
- ACHIEVE
- Status last verified
- Sep 2025
- First submitted
- 27 Apr 2022
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACHIEVE - An Adaptive Trial of the Efficacy and Effectiveness of Adoptive Cellular tHerapy wIth Ex-Vivo Expanded Allogeneic γδ T-lymphocytes (TCB008) for Patients With Refractory or Relapsed Acute Myeloid Leukaemia (AML)
- ClinicalTrials.gov ID
- NCT05358808
- Acronym / sponsor ID
- ACHIEVE / TCB008-001
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Keywords
- AML, MDS, MDS/AML, AML/MDS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Trial was early terminated due to deficiencies in the Achieve Protocol: V8.0 dated 19 January 2024.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- TC BiopharmIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 3 May 2022 (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.
This is an open-label, phase II study designed to evaluate the efficacy and effectiveness of TCB008 in patients with Acute Myeloid Leukemia (AML), or Myelodysplastic Syndromes (MDS)/AML, with either refractory or relapsed disease.
Five patients will be recruited for an initial safety cohort. The safety cohort will be followed by a two-stage Simon's Design, where a further 48 patients will be recruited into one of two cohorts and dosed with TCB008.
Detailed description
TCB008-001 (ACHIEVE) is an open-label, phase II study designed to evaluate the efficacy and effectiveness of TCB008 in patients with Acute Myeloid Leukemia (AML), or Myelodysplastic Syndromes (MDS)/AML, with either refractory or relapsed disease.
TCB008 is derived from the peripheral blood mononuclear cells (PBMCs) of unrelated, healthy donors and consists of expanded cluster designation (CD)3+ T cells expressing the γ-chain variable region 9 δ-chain variable region 2 (Vγ9Vδ2) T cell receptor (TCR); it is infused into patients to boost their immune system. It is currently developed for treatment of cancers and infectious diseases.
53 patients will take part in this study; five patients in an initial safety cohort followed by a two-stage Simon's Design that will recruit a further 48 patients into one of two patient cohorts.
Patients will be screened to assess their eligibility to enter the study 35 days prior to the first dose of the investigational medicinal product (IMP). Once enrolled in the study, patients will undergo lymphodepletion chemotherapy prior to administration of the IMP using the following regimen: fludarabine (30mg/m2/day) will be administered from days -6 to -3 (total 120mg/m2), and cyclophosphamide (0.5g/m2/day) from days -5 to -3 (total 1.5g/m2). No chemotherapy will be administered on days -2 and -1.
Cohort A will recruit patients with relapsed or refractory AML or MDS/AML. These patients will be split between one of two sub-cohorts;
- Cohort A1 will include patients with primary refractory AML or MDS/AML who have not achieved a CR, CRi, or CRh after two cycles of induction chemotherapy.
- Cohort A2 will include patients with AML or MDS/AML who have relapsed after initially achieving a CR, CRi, or CRh to previous chemotherapy.
This cohort would include MDS/AML patients with 10 to 19% blast levels in the bone marrow or peripheral blood as defined in the European Leukemia Net 2022 Criteria (as per international consensus classification of AML).
Cohort B will recruit patients with AML or MDS/AML who have achieved CR, CRi, or CRh but have a detectable measurable residual disease by MFC-MFD or Mol-RD by qPCR.
Patients may receive repeat infusions of TCB008, on up to three occasions, 14 days after the previous infusion. Re-infusions will not be preceded by lymphodepleting chemotherapy.
Patients will be followed for up to 52 weeks following the first infusion of TCB008, or until either; they are lost to follow-up, or early termination. Blood and bone marrow samples will be taken pre- and post-infusion to evaluate the study objectives and endpoints.
The total duration of study participation for each patient, from screening through to the end of study visit, is anticipated to be approximately 15 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| γδ T cells (IMP, TCB008) | Experimental | Drug: TCB008After inclusion, all patients will receive lymphodepleting chemotherapy with fludarabine 30mg/m2 Day -6 to Day -3 [total 120 mg/m2] and cyclophosphamide 0.5g/m2 [total 1.5 g/m2) Day -5 to Day -3,]. This will be followed by a rest day (Day -2). The first five patients (safety cohort) will receive 1.8mL of TCB008 (containing 3.5x10^7 to 11.0x10^7 cells) on Day 0. After treatment of the first five safety patients, the remaining 48 patients will receive 5mL of TCB008 (containing 12.0x10^7 to 23.0x10^7 cells) on Day 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 at the time of consent
- Karnofsky performance status ≥ 70% and WHO/ECOG performance status 0 -1 at enrolment and up to 2 at the time of infusion.
- Must be able to remain free of systemic corticosteroid (e.g., prednisolone) and other immunosuppressive therapy at screening and for at least 5 days prior to the infusion of γδ T cells. Maintenance replacement steroid after assessment of the primary endpoint is permitted.
- Must be able to understand and sign written informed consent and willing to participate in a clinical trial for an advanced therapy investigational medicinal product (AT(I)MP).
- For women of childbearing potential, a urine or serum pregnancy test will be performed within 7 days prior to initiating lymphodepletion. A serum pregnancy test will be performed on the day prior to the first infusion of TCB008 (i.e. day -1) and urine or serum pregnancy tests will be performed on the day of subsequent infusions with TCB008 and the results must be negative at all times that these pregnancy tests are performed. For women of childbearing potential, a serum pregnancy test will be performed at visit 17 or early termination. Patient and his/her partner must agree to use adequate contraception from the time of providing written consent through 3 months after the last study drug dose
Key exclusion criteria (23 listed)
- Suspected or proven active CNS disease.
- Previous reactions to Fludarabine or Cyclophosphamide or patients at risk of Fludarabine related neurotoxicity
- Acute promyelocytic leukaemia
- Bisphosphonates (≤8 weeks before study entry), unless continued as a standard of care medication
- Corticosteroids (cumulative dose of systemic steroids >20mg of prednisolone per day or equivalent) that cannot be discontinued 5 days prior to TCB008 infusion.
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 |
|---|---|---|
| TCB008Also: CD3+ T cells expressing the γ-chain variable region 9 δ-chain variable region 2 (Vγ9Vδ2) T cell receptor (TCR)TCB008 is derived from the peripheral blood mononuclear cells (PBMCs) of unrelated, healthy donors and consists of expanded cluster designation (CD)3+ T cells expressing the γ chain variable region 9 δ-chain variable region 2 (Vγ9Vδ2) T cell receptor (TCR); it is infused into patients to boost their immune system. It is currently developed for treatment of cancers and infectious diseases. | Drug | γδ T cells (IMP, TCB008) |
Primary outcome
Reduction in myeloblast levels in response to TCB008 dosing
Time frame: The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 15 months).
Reduction in myeloblast levels compared to baseline, measured according to the ELN AML 2022 Response Criteria.
Patient relapse and subsequent response to repeat TCB008 dosing
Time frame: The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 15 months).
Measured by the numbers of patients who, after initial response, subsequently relapse and then respond to an additional infusion.
Overall response rate to TCB008 dosing
Time frame: The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 15 months).
Overall response rate, defined as morphological CR, CRi, Rh, PR, and MLFS at 28-days post-infusion, measured according to the ELN AML 2022 Response Criteria.
Measurable Residual Disease in response to TCB008 dosing
Time frame: The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 15 months).
MRD-negative remission (CR without MRD or CR MRD-) by multiparameter flow cytometry-based MRD (MFC-MRD) or molecular MRD (Mol-MRD) assessed by qPCR, according to the ELN AML 2022 Response Criteria.
6 secondary outcomes
Severity of adverse events in response to TCB008 dosing
Time frame: The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 15 months).
Incidence and severity of CRS and neurotoxicity in response to TCB008 dosing
Time frame: The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 15 months).
Overall survival rates following TCB008 dosing
Time frame: The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 15 months).
Relapse-free survival following TCB008 dosing
Time frame: The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 15 months).
Event-free survival following TCB008 dosing
Time frame: The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 15 months).
Cumulative incidence of relapse following TCB008 dosing
Time frame: The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 15 months).
Results and safety
The study was stopped early (reason given: The Trial was early terminated due to deficiencies in the Achieve Protocol: V8.0 dated 19 January 2024.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
Emma Nicholson, MD principal investigator
Royal Marsden Hospital London
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TCB008 in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by TC Biopharm at 6 sites in United Kingdom.
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 10 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: stopped early, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The Trial was early terminated due to deficiencies in the Achieve Protocol: V8.0 dated 19 January 2024.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in myeloblast levels in response to TCB008 dosing (time frame: The total duration of study participation for each patient (from screening through end of study visit) is anticipated to be approximately 15 months).). The study lists 4 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 30 Sep 2025.