Actively Recruiting
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
Led by Cancer Research UK · Updated on 2025-07-28
84
Participants Needed
7
Research Sites
98 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
Researchers are evaluating ALETA-001, a new chimeric antigen receptor (CAR) T-cell engager, in people with B-cell malignancies who have previously received anti-CD19 CAR T-cell therapy. This Phase I/II open-label trial aims to study the safety, tolerability, timing, pharmacokinetics, and effectiveness of ALETA-001. The study is divided into a safety lead-in phase to find the best dose and timing, followed by a dose expansion phase to further assess safety and therapeutic activity. In the trial, ALETA-001 will be given by intravenous infusion every two weeks. The Phase I safety lead-in will test different dose levels and timing to decide on a recommended dose for Phase II. Phase II will focus on monitoring safety, drug levels in the blood, and how well the treatment works. Participants will receive ALETA-001 as a single agent throughout the study. Participants will be closely monitored with radiological scans before starting treatment and for up to 12 months afterward to assess response. Safety data will be collected from consent until 95 days after the last dose, and survival will be followed for up to 48 months. Researchers will also measure drug concentration and clearance in the blood during the first week after infusion. The total participation time varies depending on individual treatment and follow-up schedules.
CONDITIONS
Brief 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...
- Aged 16 years or over.
- Signed informed consent and able to cooperate with treatment and follow-up.
- Confirmed diagnosis of B-cell non-Hodgkin lymphoma (NHL) per WHO 2016 criteria.
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
- Biochemical and hematological indices within protocol-specified ranges.
- For Phase I Cohorts A & B: histologically confirmed relapsed/refractory large B-cell lymphoma (LBCL) or mantle cell lymphoma (MCL).
- Have received approved anti-CD19 CAR T-cell therapy.
- Measurable disease 4 weeks (±1 week) post CAR T, showing inadequate response, progression, or relapse within 9 months.
- For Phase I Cohorts C & D: approved by UK national CAR T Clinical Panel to receive anti-CD19 CAR T-cell therapy.
- Adequate cardiac function and resting oxygen saturation ≥92% on room air.
You will not qualify if you...
- Active or previous other malignancies that may interfere with the trial, except certain treated cancers.
- Ongoing toxic effects from prior anti-cancer treatment deemed exclusionary.
- Need for systemic immunosuppressive therapy other than replacement corticosteroids.
- Active infections or inflammatory diseases requiring treatment.
- Central nervous system involvement by lymphoma.
- Women of childbearing potential or pregnant/lactating women not adhering to contraceptive requirements.
- Male patients with partners of childbearing potential not adhering to contraceptive requirements.
- Recent major thoracic or abdominal surgery not fully recovered.
- High medical risk due to non-malignant systemic diseases or uncontrolled infection.
- Allergy to any ingredients in ALETA-001.
- Participation in other interventional trials involving investigational medicinal products.
- Immunodeficiency, immunosuppressive therapy, or post-organ transplant immunosuppression.
- Concurrent radiotherapy except for palliative reasons.
- Specific exclusion criteria related to prior CAR T toxicities and organ toxicities for Phase I cohorts.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days for Safety Lead-In Phase; up to 12 months for Dose Expansion Phase
Participants receive ALETA-001 intravenously every two weeks as part of the treatment for B-cell malignancies.
Biweekly visits for ALETA-001 administration
Duration - Up to 48 months after first dose
Participants are monitored for safety and effectiveness outcomes after treatment, including assessments up to 48 months after the first dose.
Regular follow-up visits up to 48 months
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
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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