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Lymphoma, Non-HodgkinPhase 1/2NCT06045910

A Phase I/II Trial of ALETA-001 for the Treatment of Participants With B-cell Malignancies

A Phase 1/2 study testing ALETA-001 in people with Lymphoma, Non-Hodgkin and Lymphoma, Large B-Cell, Diffuse, run by Cancer Research UK at 7 sites in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a Phase I/II multicentre, open-label trial designed to evaluate the efficacy, safety, tolerability, timing of administration and pharmacokinetics (PK) of a novel chimeric antigen receptor (CAR) T-cell engager, ALETA-001, administered by intravenous (IV) infusion as a single agent every 2 weeks in participants… Read more about this study

Who is it for?
Ages 16 years and older
What is being tested?
ALETA-001
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
7 sitesUnited Kingdom
Study dates
7 Feb 2024to 21 Dec 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • For all participants
  • Criteria to be met prior to enrolment in the trial:
  • Aged 16 years or over.
  • Written (signed and dated) informed consent and be capable of co-operating with ALETA-001 administration and follow-up.
  • Confirmed diagnosis of B-cell NHL according to World Health Organization (WHO) 2016 criteria.
  • Eastern Cooperative Oncology Group performance status of 0, 1 or 2.
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  • Biochemical indices within protocol specified ranges.
  • Cohort Specific Inclusion criteria (for Phase I Cohorts A \& B) Criteria to be met prior to enrolment in the trial.
  • Histologically confirmed diagnosis of relapsed/refractory LBCL or MCL.
  • Have received an approved anti-CD19 CAR T-cell therapy.
  • Objectively evaluable or measurable disease at 4 weeks (±1 week) post CAR T, which demonstrates:
  • inadequate or incomplete response (PR or SD), or
  • PD if there is a reasonable expectation of deriving benefit from trial treatment, or
  • initial response followed by relapse within 9 months assessed according to Lugano Criteria.
  • Haematological indices within protocol specified ranges.
  • Cohort Specific Inclusion criteria (for Phase I Cohorts C \& D) Criteria to be met prior to lymphodepleting chemotherapy for CAR T therapy.
  • Histologically confirmed diagnosis of relapsed/refractory LBCL or MCL.
  • Approved by the UK national CAR T Clinical Panel (NCCP) to receive an approved anti-CD19 CAR T-cell therapy.
  • Haematological indices within protocol specified ranges.
  • Adequate cardiac function within protocol specified ranges with no clinical symptoms or signs of heart failure.
  • Resting O2 saturation of ≥92% on room air.
  • Eligibility for participants in Phase II of the trial will depend on timing of administration of ALETA-001 which will be recommended by the Safety Review Committee (SRC).

Who cannot join

  • Active or previous malignancies of other types that, in the opinion of the Investigator, should exclude the participant. Exceptions include adequately treated cone biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin and patients with asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or who require only hormonal therapy and have had normal prostate specific antigen for >1 year prior to the start of therapy. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for 2 years or more and are deemed at negligible risk for recurrence, are eligible for the trial.
  • Any ongoing toxic manifestation of previous anti-cancer treatment that, in the opinion of the Investigator, should exclude the participant.
  • Ongoing need for systemic immunosuppressive therapy other than replacement dose of corticosteroids. Intermittent topical, inhaled or intranasal corticosteroids are permitted.
  • Presence of active infections and/ or inflammatory disease requiring active management.
  • Documented current central nervous system involvement by lymphoma.
  • Women of childbearing potential (or are already pregnant or lactating) unless willing to adhere to protocol-defined contraceptive requirements.
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  • Male patients with partners of childbearing potential unless willing to adhere to protocol-defined contraceptive requirements.
  • Major thoracic or abdominal surgery from which the participant has not yet recovered.
  • At high medical risk because of non-malignant systemic disease including active uncontrolled infection.
  • Hypersensitivity to any of the ingredients/excipients in ALETA-001.
  • Participation in another interventional clinical trial, whilst taking part in this trial of ALETA-001. Participation in an observational trial or interventional clinical trial that does not involve administration of an IMP and that would not place an unacceptable burden on the participant, in the opinion of the Investigator and CDD, would be acceptable.
  • Participants with any congenital or acquired immunodeficiency syndrome or who are receiving immunosuppressive therapy (including any dose of systemic corticosteroids), or who are immunosuppressed post organ transplant. However, participants receiving inhaled corticosteroids and participants with a history of allergy (other than anaphylaxis) are eligible, as are participants with a history of autoimmune disease.
  • Any other condition that, in the Investigator's opinion, would mean that the trial is not in the best interests of the participant.
  • Concurrent radiotherapy (except for palliative reasons).
  • Cohort specific exclusion criteria prior to enrolment in the trial (for Phase I
  • Cohorts A \& B):
  • Participants who have received any other systemic anti-cancer treatment post-CAR T.
  • Potential participants who experienced any of the following because of the initial CAR T treatment:
  • Grade 4 CRS or ICANS post CAR T infusion.
  • Grade ≥3 CRS or ICANS persisting beyond 7 days despite optimal therapy.
  • Any Grade ≥1 CRS or ICANS must have fully resolved.
  • Any Grade ≥3 organ toxicity (other than haematologic toxicity) following CAR T infusion must have improved to Grade ≤2 for at least 48 hours prior to ALETA-001 infusion.
  • Cohort specific exclusion criteria prior to ALETA-001 infusion between Day 10-18 post CAR T-cell infusion (for Phase I Cohorts C \& D):
  • Grade 4 CRS or ICANS post CAR T infusion.
  • Grade ≥3 CRS or ICANS persisting beyond 7 days despite optimal therapy.
  • Any Grade ≥2 CRS or ICANS must have improved to Grade ≤1 for at least 48 hours prior to ALETA-001 infusion.
  • ECOG performance status ≥3.
  • Any Grade ≥3 organ toxicity (other than haematologic toxicity) following CAR T infusion must have improved to Grade ≤2 for at least 48 hours prior to ALETA-001 infusion.
  • Any unresolved serious active infection which in the opinion of the Investigator precludes ALETA-001 infusion (ongoing need for IV antimicrobial therapy per se is not an exclusion).

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Alka Lal contact

+442034696034

aleta@cancer.org.uk

7 sites in 1 country

United Kingdom7 sites, 7 recruiting

  • University Hospital Birmingham NHS Foundation Trust

    Birmingham

    Sridhar Chaganti, Dr, 01213714379, sridhar.chaganti@uhb.nhs.uk

    Recruiting

  • Cambridge University Hospitals

    Cambridge

    Ben Uttenthal, Dr, 01223 586928, b.uttenthal@nhs.net

    Recruiting

  • St James's University Hospital

    Leeds

    Mary Owen, Dr, 01132068577, mary.owen1@nhs.net

    Recruiting

  • University Hospital London Hospital

    London

    William Townsend, Dr, 0203 447 9443, william.townsend@nhs.net

    Recruiting

  • Manchester Royal Infirmary

    Manchester

    Jane Norman, Dr, 01612764178, 01612768686, Jane.norman@mft.nhs.uk

    Recruiting

  • The Christie Hospital

    Manchester

    Adam Gibb, Dr, 0161 446 3753, adam.gibb@nhs.net

    Recruiting

  • Royal Marsden Hospital

    Sutton

    Sunil Iyengar, Dr, 02078082609, sunil.iyengar@rmh.nhs.uk

    Not yet recruiting

Other trials in United Kingdom

About this study

Official title: A Cancer Research UK Phase I/II Trial of ALETA-001 in Participants Who Have Received an Anti-CD19 CAR T-Cell Therapy for the Treatment of B-cell Malignancies

This is a Phase I/II multicentre, open-label trial designed to evaluate the efficacy, safety, tolerability, timing of administration and pharmacokinetics (PK) of a novel chimeric antigen receptor (CAR) T-cell engager, ALETA-001, administered by intravenous (IV) infusion as a single agent every 2 weeks in participants with B-cell malignancies post CD19 CAR T-cell therapy. This first in human study is divided into 2 parts: a safety lead-in phase (Phase I) and a dose expansion phase (Phase II). Different dose levels of ALETA-001 and timing of administration will be evaluated in Phase I in order to define a recommended dosing level and time of administration for Phase II. Phase II will further evaluate the safety, PK and therapeutic activity of ALETA-001.

Being tested
ALETA-001
Keywords
Neoplasms, Immunotherapy, Adoptive, Receptors, Chimeric Antigen, Receptors, Antigen, T-Cell, Antigens, CD19
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Lymphoma, Follicular, Lymphoma, B-Cell, Neoplasms

What participants receive

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

  • ALETA-001Drug

    ALETA-001 will be administered intravenously (IV) every two weeks.

Study groups in NCT06045910
Study groupRoleWhat they receive
Safety Lead-In PhaseExperimentalNot described
Receives: Drug: ALETA-001
Dose Expansion PhaseExperimentalNot described
Receives: Drug: ALETA-001

What is being measured

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

  1. Dose level of ALETA-001 and timing of administration for use in Dose Expansion (Safety Lead-in Phase).

    Determine a dose level that is deemed tolerable and timing of administration based on available safety and pharmacodynamic data.

    Measured: Day 1 to Day 28.

  2. Number of Participants who experience dose limiting toxicities (DLTs).

    DLTs will be assessed up to Day 28 and are defined as toxicities that meet pre-defined severity criteria and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the 28 days of the first dose of ALETA-001.

    Measured: Up to Day 28.

  3. Number of Participants who experience Grade 3, 4 or 5 related adverse event (AEs).

    Related AEs are those considered by the investigator to be possibly, probably or highly probably related to ALETA-001. Events of cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity (ICANS) are graded according to the American Society for Transplantation and Cellular Therapy grading criteria. All other AEs are graded according to the Common Terminology Criteria for AEs (CTCAE) Version 5.0.

    Measured: Safety data will be collected from the time of informed consent until 95 days after the last dose of ALETA-001. The average time from consent to the end of follow up will be presented.

  4. Best Overall Response (Dose Expansion Phase).

    Best Overall Response according to Lugano criteria (Cheson, Journal of Clinical Oncology, 2014), the number of participants taking part in the Dose Expansion Phase with best overall response of complete response (CR), partial response (PR), no response or stable disease (SD/NR), and progressive disease (PD).

    Measured: Radiological assessment from within 28 days before starting ALETA-001 and up to 12 months after.

  5. Progression-Free Survival (PFS) (Dose Expansion Phase).

    Median PFS measured from first dose of ALETA-001 to date of progression according to Lugano criteria or date of death without a previous progression recorded.

    Measured: From date of first dose of ALETA-001 up to 12 months.

  6. Time to Progression (TTP) (Dose Expansion Phase).

    Median TTP measured from first dose of ALETA-001 to date of progression according to Lugano criteria. Participants who die without recorded progression will be censored.

    Measured: From date of first dose of ALETA-001 up to 12 months.

  7. Overall Survival (OS) (Dose Expansion Phase).

    Median OS measured from first dose of ALETA-001 to date of death due to any cause or to the date of censoring at the last time the participant was known to be alive.

    Measured: Follow-up until end of trial, estimated to be up to 48 months.

Secondary outcomes (9)

  1. Best Overall Response (Safety Lead-in Phase).

    Best Overall Response according to Lugano criteria, the number of participants taking part in the Safety Lead-in Phase with best overall response of complete response (CR), partial response (PR), no response or stable disease (SD), and progressive disease (PD).

    Measured: Radiological assessment from within 28 days before starting ALETA-001 and up to 12 months after.

  2. Progression-Free Survival (PFS) (Safety Lead-in Phase).

    Median PFS measured from first dose of ALETA-001 to date of progression according to Lugano criteria or date of death without a previous progression recorded.

    Measured: From date of first dose of ALETA-001 up to 12 months.

  3. Time to Progression (TTP) (Safety Lead-in Phase).

    Median TTP measured from first dose of ALETA-001 to date of progression according to Lugano criteria. Participants who die without recorded progression will be censored.

    Measured: From date of first dose of ALETA-001 up to 12 months.

  4. Overall Survival (OS) (Safety Lead-in Phase).

    Median OS measured from first dose of ALETA-001 to date of death due to any cause or to the date of censoring at the last time the participant was known to be alive.

    Measured: Follow-up until end of trial, estimated to be up to 48 months.

  5. Maximum observed serum concentration (Cmax) of ALETA-001.

    Measurement of Cmax of ALETA-001 as appropriate.

    Measured: Day 1 to Day 7.

  6. Terminal elimination half-life (t1/2) of ALETA-001.

    Measurement of t1/2 of ALETA-001 as appropriate.

    Measured: Day 1 to Day 7.

  7. Area under the concentration-time curve (AUC) of ALETA-001.

    Measurement of AUC of ALETA-001 as appropriate.

    Measured: Day 1 to Day 7.

  8. Volume of distribution (Vss) of ALETA-001.

    Measurement of Vss of ALETA-001 as appropriate.

    Measured: Day 1 (before first ALETA-001 infusion) to Day 7.

  9. Clearance (CL) of ALETA-001.

    Measurement of CL of ALETA-001 as appropriate.

    Measured: Day 1 to Day 7.

Timeline

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

  1. First posted21 Sep 2023
  2. Study start7 Feb 2024
  3. Primary completionFeb 2028 (estimated)
  4. Study completion21 Dec 2029 (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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06045910
Sponsor's protocol ID
CRUKD/23/001
Other IDs
IRAS ID: 1007028
Status last verified
Jul 2025
First submitted
15 Aug 2023
Last updated
28 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual de-identified patient data that underlie the results reported will be shared with researchers whose proposed use of the data is approved by a review committee of the Sponsor.

Publications

  • Kuhnl A, Kirkwood AA, Northend M, Alajangi R, Uttenthal B, Norman J, Hiew H, Seymour F, Maybury BD, Osborne W, Sillito F, Abdulgawad A, Jones C, Delaney A, Townsend W, Panopoulou A, Gribben JG, Bataillard E, Mathew A, Martinez-Calle N, Gajendran L, Davies AJ, Chavda N, Kumar E, Sanderson R, Kamat S, Petrides G, Roddie C, Menne T, Chaganti S. Early PET response predicts the risk of relapse after 2L axi-cel in large B-cell lymphoma. Blood Adv. 2026 Jun 9;10(11):3777-3786. doi: 10.1182/bloodadvances.2026019802.

    PubMed 41894687

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ALETA-001 in people with Lymphoma, Non-Hodgkin and Lymphoma, Large B-Cell, Diffuse, run by Cancer Research UK at 7 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 22 inclusion and 29 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: looking for participants now, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 combined 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.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alka Lal (+442034696034, aleta@cancer.org.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose level of ALETA-001 and timing of administration for use in Dose Expansion (Safety Lead-in Phase). (time frame: Day 1 to Day 28.). The study lists 7 primary outcomes in all. 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 NCT06045910, which also lists 1 linked publication.

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 28 Jul 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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