Geriatric assessment before CAR‑T or bispecific antibody therapy to predict side effects and outcomes in older adults
Pragmatic Geriatric Assessment (pGA) Before Bispecific Antibody and CAR-T-Cell Therapy (GA-ACT Trial) for the Prediction of Toxicity and Outcomes in Older Patients Scheduled for Chimeric Antigen Receptor T-Cell Therapy (CAR-T-Cell-Therapy) or Bispecific Antibody (bsAB) Treatment
This study will test whether a brief geriatric assessment done before CAR‑T or bispecific antibody treatment can help predict side effects and outcomes for people aged 65 and older with aggressive lymphoma or multiple myeloma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 208 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Drugs / interventions | CAR-T |
| Locations | 2 sites (Bern and 1 other locations) |
| Trial ID | NCT07309497 on ClinicalTrials.gov |
What this trial studies
This observational, multicenter study enrolls patients aged 65 and older who are scheduled to receive CAR‑T cell therapy or bispecific antibody treatment. Participants complete a pragmatic geriatric assessment before treatment and investigators collect data on treatment‑related toxicities, complications, and clinical outcomes during follow‑up. The study aims to link baseline geriatric measures (for example functional status, cognition, nutrition, and comorbidities) with short‑ and long‑term tolerability and success of these therapies. Recruitment is taking place at Swiss university hospitals and records will be analyzed to identify predictors of poor outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients aged 65 or older who are scheduled for CAR‑T cell or bispecific antibody therapy and can give informed consent in German or French.
Not a fit: People younger than 65, those who cannot complete the geriatric assessment or cannot consent, and patients who cannot attend the participating Swiss centers are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the assessment could help doctors identify older patients at higher risk of severe side effects so care can be personalized and supportive measures targeted.
How similar studies have performed: Geriatric assessments have shown predictive value for treatment tolerance in other cancer settings, but evidence specifically for CAR‑T and bispecific antibody therapies in older adults is limited and this approach is relatively novel in that context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * male or female patients age ≥ 65 years, * scheduled for CAR-T-cell or bsAB treatments * signed informed consent * sufficient knowledge of the German or French language Exclusion Criteria: * inability to understand or sign informed consent * refuse to consent
Where this trial is running
Bern and 1 other locations
- Inselspital Bern — Bern, Switzerland (Recruiting)
- Universitätsspital Zürich — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Wiebke Rösler, Dr. med. — Universitätsspital Zürich
- Study coordinator: Wiebke Rösler, Dr. med.
- Email: wiebke.roesler@usz.ch
- Phone: +4144 255 11 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.