Trial of an investigational drug after the rejection of an allogeneic transplant.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion Publica Andaluza para la Gestion de la Investigacion en Salud de Sevilla (FISEVI)

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

22 Sep 2025 → ongoing

Decision date (initial)

2024-05-06

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

External identifiers

EU CT number

2022-503063-15-00

ClinicalTrials.gov

NCT05982275

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Safety

Assess the feasibility of generating HUVR-CARTemis-1 and its safety in terms of maximum tolerated dose in patients with multiple myeloma in 1st or successive relapses after allogeneic transplant.

Secondary objectives 1

1. Evaluate the response at 3, 6 and 12 months after the administration of HUVR-CARTemis-1, evaluate the duration of the response, assess overall and event-free survival after administration of HUVR-CARTemis-1, analyze the biological characteristics of the HUVR-CARTemis-1 cells generated and infused, evaluate the persistence of HUVR-CARTemis-1 cells in peripheral blood after administration.

Conditions and MedDRA coding

Multiple myeloma.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1. Patients > 18 years old with a diagnosis of post-allogeneic transplant relapse multiple myeloma. 2. Medical illness 3. Previous treatment with 2 lines before and/or after allogeneic transplant. 4. Patients who are not receiving immunosuppressants at least 1 month before inclusion and who do not have active GVHD. 5. ECOG functional status from 0 to 1. 6. Life expectancy greater than 3 months 7. Patients who give their consent by signing the Informed Consent document.

Exclusion criteria 1

1. 1. Active systemic immunosuppressive therapy. 2. Patients who have previously received CAR-T Anti-BCMA treatment. Patients who have received another type of anti-BCMA therapy will not be excluded, although in this case the positivity for BCMA in myeloma cells must be confirmed at the time of inclusion. 3. Absolute lymphocyte count <0.2x109/L. 4. Previous malignancy, except if in complete remission >3 years, with the exception of cutaneous carcinoma (non-melanoma). 5. Active infection requiring treatment. 6. Active HIV, HBV, or HCV infection. 7. Uncontrolled medical illness. 8. Severe organic disease that meets any of the following criteria: EF <40%, DLCO < 40%, GFR < 50 ml/min, bilirubin > 3 NV (except Gilbert's syndrome). 9. Previous diagnosis of symptomatic AL amyloidosis or POEMS syndrome. 10. Pregnant or lactating women. 11. Women of childbearing potential who are unable or unwilling to use highly effective contraceptive methods 12. Men unable or unwilling to use highly effective contraceptive methods 13. Contraindication to receive lymphodepletive chemotherapy.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Primary feasibility variable: Number of cases in which the manufacturing process is completed and HUVR-CARTemis-1 cells are infused.
2. Safety variables: Maximum tolerated dose of HUVR-CARTemis-1 determined based on the incidence in different patient cohorts of the following toxicities: Rate of patients developing cytokine release syndrome and/or neurological toxicity and/or macrophage activation. Rate of patients developing graft-versus-recipient disease - Patients developing grade 3-4 toxicities that do not respond to standard treatment. Presence of infusional reactions. -Presence of SAEs, SUSARs throughout the study.
3. Safety variables: Tumour lysis syndrome.

Secondary endpoints 14

1. Determine cytopenias developed during the first 90 days or prolonged
2. Duration of response in responder patients
3. Overall response rate
4. Time to complete remission
5. Time to best response
6. Rate of bone marrow-negative EMR
7. Extramedullary disease response rate
8. Progression-free survival
9. HUVR-CARTemis-1 administration and disease progression or death
10. Overall survival and patient death
11. Persistence of HUVR-CARTemis-1 in peripheral blood and marrow
12. Evaluation of the biological characteristics of HUVR-CARTemis-1
13. BCMA expression
14. Levels of soluble BCMA

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 7

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Publica Andaluza para la Gestion de la Investigacion en Salud de Sevilla (FISEVI)

Sponsor organisation

Fundacion Publica Andaluza para la Gestion de la Investigacion en Salud de Sevilla (FISEVI)

Address

Avenida De Manuel Siurot S/n

City

Sevilla

Postcode

41013

Country

Spain

Scientific contact point

Organisation

Fundacion Publica Andaluza para la Gestion de la Investigacion en Salud de Sevilla (FISEVI)

Contact name

Unidad de Investigación Clínica y Ensayos Clínicos del Hospital Universitario Virgen del Rocío

Public contact point

Organisation

Fundacion Publica Andaluza para la Gestion de la Investigacion en Salud de Sevilla (FISEVI)

Contact name

Unidad de Investigación Clínica y Ensayos Clínicos del Hospital Universitario Virgen del Rocío

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 18 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications