NCT05982275Not yet recruitingPhase 1/2
Trial of an Investigational Drug After Rejecting the Relapse of an Allogeneic Transplant
Anti-BCMA Chimeric Antigen Receptor (CARTemis-1) T-lymphocyte Therapy in the Treatment of Patients With Multiple Myeloma in Relapse After Allogeneic Transplant: Endothelial Growth Factor Receptor Expression as a Control Mechanism of Treatment-derived Complications
Source: ClinicalTrials.gov · Last updated 14 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Most patients with multiple myeloma (MM) die due to relapse resistant to current treatment, including treatment with anti-B cell maturation antigen (BCMA) CAR-T cells. To overcome some of the potential limitations of this therapy, a new and optimized Anti-BCMA CAR-T has been developed, with the aim of using it in patients with MM who relapse after Allogeneic Haematopoietic Haematopoietic Progenitor. This trial is a prospective phase I/II trial with a 3+3 design. Once Dose Limiting Toxicity is identified, Phase II will begin to assess the efficacy of the procedure.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 2 May 2023
- Start date
- 30 Dec 2024
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Diseases
- Multiple myeloma
- NCT number
- NCT05982275
- EU CT number
- 2022-503063-15-00
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 25
- From 30 Dec 2024 to the primary completion date, 31 Dec 2029
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have previously received treatment with CAR-T Anti-BCMA.
- Previous neoplasm, except if it has been in complete remission \>3 years, with the exception of skin carcinoma (non-melanoma)
- Previous diagnosis of symptomatic amyloid light chain or primary amyloidosis or POEMS Syndrome.
- Contraindication to receive lymphodepleting chemotherapy.
Other illness
- Active infection requiring treatment.
- Active HIV, hepatitis B virus or hepatitis C virus infection.
- Uncontrolled medical illness.
- Patients with known hypersensitivity to the active ingredients or any of the excipients of the product to be infused.
Lab values
- Absolute lymphocyte count \<0.2x109/L
- Severe organic disease that meets any of the following criteria: left ventricular ejection fraction \<40%, carbon monoxide diffusion test \<40%, glomerular filtration rate \<50 ml/min, bilirubin \>3 normal value (except Gilbert syndrome).
Age
- Women of childbearing age, unable or unwilling to use highly effective contraceptive methods.
- Men who cannot or do not wish to use highly effective contraceptive methods. The partner of the male participants, if they are women of childbearing age, must also use highly effective contraceptive methods during the study period.
Other
- Active systemic immunosuppressive treatment
- Pregnant or lactating women.
Who the study is looking for
- Patients \> 18 years old with a diagnosis of post-allogeneic transplant relapse multiple myeloma.
- Measurable disease at the time of screening
- Previous treatment with ≥2 lines before and/or after allogeneic transplant.
- Patients who are not receiving immunosuppressants at least 1 month before inclusion and who do not have active graft-versus-host disease.
- Eastern Cooperative Oncology Group functional status from 0 to 1.
- Life expectancy greater than 3 months (at the time of screening)
- Patients who give their consent by signing the Informed Consent document.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.