Actively Recruiting
A Phase I/II Trial of ALETA-001 for the Treatment of Participants With B-cell Malignancies
Led by Cancer Research UK · Updated on 2025-07-28
84
Participants Needed
7
Research Sites
306 weeks
Total Duration
On this page
Sponsors
C
Cancer Research UK
Lead Sponsor
A
Aleta BioTherapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase I/II Trial of ALETA-001 for the Treatment of Participants With B-cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 16 years or older
- Signed informed consent and ability to cooperate with treatment and follow-up
- Confirmed diagnosis of B-cell non-Hodgkin lymphoma by WHO 2016 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Biochemical lab results within protocol-specified ranges
- For Phase I Cohorts A & B: histologically confirmed relapsed or refractory diffuse large B-cell lymphoma (LBCL) or mantle cell lymphoma (MCL)
- Received approved anti-CD19 CAR T-cell therapy
- Measurable or evaluable disease 4 weeks (±1 week) post CAR T showing inadequate or incomplete response, progression with expected benefit, or relapse within 9 months
- Hematological indices within protocol ranges
- For Phase I Cohorts C & D: histologically confirmed relapsed/refractory LBCL or MCL
- Approved by UK CAR T Clinical Panel to receive anti-CD19 CAR T therapy
- Hematological indices within protocol ranges
- Adequate cardiac function without heart failure symptoms
- Resting oxygen saturation ≥92% on room air
- Eligibility for Phase II depends on timing recommended by Safety Review Committee
You will not qualify if you...
- Other active or prior malignancies excluding certain treated skin or cervical cancers and stable prostate cancer
- Ongoing toxic effects from previous cancer treatments deemed exclusionary
- Need for systemic immunosuppressive therapy beyond replacement corticosteroids
- Active infections or inflammatory diseases needing treatment
- Central nervous system involvement by lymphoma
- Women pregnant, lactating, or not following contraceptive rules; male partners of childbearing potential not following contraceptive rules
- Recent major thoracic or abdominal surgery without recovery
- High medical risk from non-cancer systemic disease or uncontrolled infection
- Allergy to ALETA-001 ingredients
- Participation in other interventional clinical trials involving investigational medicinal products
- Immunodeficiency syndromes or receiving immunosuppressive therapy, except inhaled corticosteroids or non-anaphylactic allergies
- Any condition judged not in participant's best interest by Investigator
- Concurrent radiotherapy except for palliative use
- For Phase I Cohorts A & B: systemic anti-cancer treatment post-CAR T
- Severe cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) after CAR T infusion not resolved or persisting beyond protocol thresholds
- Grade ≥3 organ toxicity not improved to Grade ≤2 before ALETA-001
- For Phase I Cohorts C & D: similar CRS/ICANS restrictions with slightly different grade thresholds
- ECOG performance status ≥3
- Unresolved active serious infection contraindicating ALETA-001 infusion
AI-Screening
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Trial Site Locations
Total: 7 locations
1
University Hospital Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Actively Recruiting
2
Cambridge University Hospitals
Cambridge, United Kingdom
Actively Recruiting
3
St James's University Hospital
Leeds, United Kingdom
Actively Recruiting
4
University Hospital London Hospital
London, United Kingdom
Actively Recruiting
5
Manchester Royal Infirmary
Manchester, United Kingdom
Actively Recruiting
6
The Christie Hospital
Manchester, United Kingdom
Actively Recruiting
7
Royal Marsden Hospital
Sutton, United Kingdom
Not Yet Recruiting
Research Team
A
Alka Lal
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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