Relapsed or Refractory Multiple MyelomaEarly Phase 1NCT06298266
To Assess Safety, Tolerability, and Efficacy of Anti-GPRC5D-CD19-CAR-T in Relapsed/Refractory Multiple Myeloma
A Early Phase 1 study testing infusion of GPRC5D-CD19 CAR T injection in people with Relapsed or Refractory Multiple Myeloma, run by Guangdong Second Provincial General Hospital at 1 site in China.
Trial summary
To evaluate the safety and tolerability of anti-GPRC5D-CD19 CAR-T cells infusion in subjects with relapsed and refractory multiple myeloma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma
- What is being tested?
- infusion of GPRC5D-CD19 CAR T injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 29 Mar 2024to 31 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. The patient or their legal guardian understands and voluntarily signs the informed consent form and is expected to complete the follow-up examinations and treatments.
- 2. Age between 18-75 years, regardless of gender. 3. Diagnosed with multiple myeloma according to the IMWG diagnostic criteria, and GPRC5D expression in bone marrow is positive (>10%).
- 4. Has failed treatment with at least three different mechanisms of drugs (including chemotherapy, proteasome inhibitors, immune modulators, etc.), or has experienced disease progression or relapse within 6 months after the last treatment.
- 5. Measurable lesions are present based on any of the following criteria during screening: (1) Serum monoclonal immunoglobulin (M-protein) level ≥1.0 g/dL; (2) Urine M-protein level ≥200 mg/24 hours; (3) Diagnosed with light chain multiple myeloma with no measurable lesions in serum or urine: Serum free light chain ≥10 mg/dL and abnormal serum free light chain κ/γ ratio.
- 6. The patient has recovered from toxicities associated with previous treatment, i.e., CTCAE toxicity grade <2 (unless the abnormality is related to the tumor or stable, with no significant impact on safety or efficacy as determined by the investigator).
- 7. ECOG performance status of 0-2 and an expected survival of more than 3 months.
Show all 14Show fewer
- 8. Adequate organ function:
- Alanine transaminase (ALT) ≤3 times the upper limit of normal (ULN);
- Aspartate transaminase (AST) ≤3 times ULN;
- Total bilirubin ≤1.5 times ULN;
- Serum creatinine ≤1.5 times ULN, or creatinine clearance ≥60 mL/min;
- Indoor oxygen saturation ≥92%;
- Left ventricular ejection fraction (LVEF) ≥45%, confirmed by echocardiography with no clinically significant pericardial effusion or clinically significant electrocardiogram findings;
- No clinically significant pleural effusion. 9. Able to establish the required venous access for sample collection, with no contraindications for white blood cell collection.
Who cannot join
- 1. Diagnosed with or treated for invasive malignant tumors other than multiple myeloma.
- 2. Previously received anti-tumor treatments including targeted therapy, epigenetic therapy, experimental drug therapy, or invasive experimental medical devices within 14 days or at least 5 half-lives (whichever is shorter) before the collection and preparation of CAR-T cells. Also, received monoclonal antibody therapy for relapsed/refractory multiple myeloma within 21 days, received cytotoxic therapy within 14 days, received proteasome inhibitor therapy within 14 days, received immunomodulatory agent therapy within 7 days, or received radiation therapy within 14 days (except for bone marrow reserves with field coverage ≤5%).
- 3. Suspected involvement of multiple myeloma in the central nervous system or meninges confirmed by MRI or CT, or presence of other active central nervous system diseases.
- 4. Screening criteria include plasma cell leukemia (according to standard classification, plasma cells >2.0×109/L), Waldenstrom macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or secondary AL amyloidosis.
- 5. Positive for hepatitis B surface antigen (HBsAg) and positive for HBV-DNA; positive for hepatitis C virus (HCV) antibody; positive for human immunodeficiency virus (HIV) antibody; cytomegalovirus (CMV) DNA test result ≥500 copies/mL; positive for syphilis test.
- 6. Positive for hepatitis C virus (HCV) antibody; positive for human immunodeficiency virus (HIV) antibody; cytomegalovirus (CMV) DNA test result ≥500 copies/mL; positive for syphilis test.
Show all 15Show fewer
- 7. History of severe allergies defined as grade II or above reactions, with clinical manifestations including airway obstruction (runny nose, coughing, wheezing, difficulty breathing), tachycardia, hypotension, arrhythmia, gastrointestinal symptoms (nausea, vomiting), urinary or fecal incontinence, laryngeal edema, bronchospasm, cyanosis, shock, respiratory or cardiac arrest, or known allergy to any active ingredient, excipient, murine-derived product, or xenogeneic protein contained in this trial (including the CleenRx regimen).
- 8. Severe cardiac diseases including but not limited to severe arrhythmias, unstable angina pectoris, extensive myocardial infarction, New York Heart Association Class III or IV heart failure, myocardial infarction within 6 months before screening or coronary artery bypass graft (CABG), unexplained history of syncope unrelated to vasovagal or dehydration, severe non-ischemic cardiomyopathy, or uncontrolled hypertension (defined as failure to achieve blood pressure goals despite using ≥3 antihypertensive drugs, including diuretics, for ≥1 month or effective blood pressure control requiring ≥4 antihypertensive drugs).
- 9. Unstable systemic diseases, including but not limited to severe liver, kidney, or metabolic diseases requiring medication.
- 10. Acute/chronic graft-versus-host disease (GVHD) within 6 months before screening or patients requiring immunosuppressive therapy for GVHD.
- 11. Active autoimmune or inflammatory diseases of the nervous system (e.g., Guillain-Barré syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically significant active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES)).
- 12. Presence of tumor emergencies (e.g., spinal cord compression, intestinal obstruction, leukostasis, tumor lysis syndrome) requiring urgent treatment during screening or before cell infusion.
- 13. Uncontrolled bacterial, fungal, viral, or other infections requiring antibiotic treatment.
- 14. Underwent major surgery (excluding diagnostic surgery and biopsies) within 4 weeks before CleenRx or planned major surgery during the study, or incomplete healing of surgical wounds before enrollment.
- 15. Received (attenuated) live virus vaccines within 4 weeks before screening. 16. Presence of severe mental disorders. 17. Alcohol or substance abuse history. 18. Pregnant or breastfeeding women, and female subjects or male subjects with partners planning pregnancy within 2 years after cell infusion, and subjects who plan to become pregnant within 2 years after cell infusion. Additionally, according to the investigator's judgment and/or clinical criteria, patients with contraindications to any study procedures or other medical conditions that may expose them to unacceptable risks.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, 510317
Qing Zhang, +862089169186, zhqing@vip.163.com
About this study
Official title: Clinical Study to Evaluate the Safety, Tolerability and Initial Efficacy of Anti-GPRC5D-CD19-CAR-T in Patients With Relapsed/Refractory Multiple Myeloma
To evaluate the safety and tolerability of anti-GPRC5D-CD19 CAR-T cells infusion in subjects with relapsed and refractory multiple myeloma
Read the detailed description
This study is a single-arm, single-center clinical study of IIT to evaluate the safety, tolerability, pharmacokinetic profile, and initial efficacy of GPRC5D-CD19 CAR T cells in subjects with MM. The safety of GPRC5D-CD19 CAR T was evaluated by observing adverse events after cell therapy. Evaluate the effectiveness of GPRC5D-CD19 CAR T treatment compared to the results of the subjects' own previous standard treatment regimens or base data. Blood and bone marrow were collected before and 24 months after the GPRC5D-CD19 CAR T infusion to detection.
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Being tested
- infusion of GPRC5D-CD19 CAR T injection
- Keywords
- GPRC5D-CD19 CART, Multiple myeloma
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infusion of GPRC5D-CD19 CAR T injectionBiological
Infusion of GPRC5D-CD19 CAR T cells injection by dose of 1.0×10^6 /kg±20 % CAR-T ，3.0×10^6 /kg±20%、6.0×10^6 /kg±20%. Administration method: intravenous infusion. Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.
| Study group | Role | What they receive |
|---|---|---|
| infusion of GPRC5D-CD19 CAR T injection | Experimental | Infusion of GPRC5D-CD19 CAR T cells injection by dose of 1.0×10^6 /kg±20 % CAR-T ，3.0×10^6 /kg±20%、6.0×10^6 /kg±20%. Administration method: intravenous infusion. Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion. Receives: Biological: infusion of GPRC5D-CD19 CAR T injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Subjects were evaluated for efficacy according to the IMWG Efficacy Assessment Criteria (2016 revision).
Measured: Day 0, Month 1.5, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 18, Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start29 Mar 2024 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Relapsed or Refractory Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Second Provincial General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing Zhang, Guangdong Second Provincial General Hospital
- Investigators
- Qing Zhang, Doctoral, Principal investigator, Guangdong Second Provincial General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298266
- Sponsor's protocol ID
- GD2H-XYK-001
- Status last verified
- Mar 2024
- First submitted
- 29 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen D, You F, Xiang S, Wang Y, Li Y, Meng H, An G, Zhang T, Li Z, Jiang L, Wu H, Sheng B, Zhang B, Yang L. Chimeric antigen receptor T cells derived from CD7 nanobody exhibit robust antitumor potential against CD7-positive malignancies. Am J Cancer Res. 2021 Nov 15;11(11):5263-5281. eCollection 2021.
PubMed 34873460Benmebarek MR, Karches CH, Cadilha BL, Lesch S, Endres S, Kobold S. Killing Mechanisms of Chimeric Antigen Receptor (CAR) T Cells. Int J Mol Sci. 2019 Mar 14;20(6):1283. doi: 10.3390/ijms20061283.
PubMed 30875739Harris DT, Kranz DM. Adoptive T Cell Therapies: A Comparison of T Cell Receptors and Chimeric Antigen Receptors. Trends Pharmacol Sci. 2016 Mar;37(3):220-230. doi: 10.1016/j.tips.2015.11.004. Epub 2015 Dec 17.
PubMed 26705086Srivastava S, Riddell SR. Engineering CAR-T cells: Design concepts. Trends Immunol. 2015 Aug;36(8):494-502. doi: 10.1016/j.it.2015.06.004. Epub 2015 Jul 11.
PubMed 26169254Dotti G, Gottschalk S, Savoldo B, Brenner MK. Design and development of therapies using chimeric antigen receptor-expressing T cells. Immunol Rev. 2014 Jan;257(1):107-26. doi: 10.1111/imr.12131.
PubMed 24329793Neelapu SS, Locke FL, Bartlett NL, Lekakis LJ, Miklos DB, Jacobson CA, Braunschweig I, Oluwole OO, Siddiqi T, Lin Y, Timmerman JM, Stiff PJ, Friedberg JW, Flinn IW, Goy A, Hill BT, Smith MR, Deol A, Farooq U, McSweeney P, Munoz J, Avivi I, Castro JE, Westin JR, Chavez JC, Ghobadi A, Komanduri KV, Levy R, Jacobsen ED, Witzig TE, Reagan P, Bot A, Rossi J, Navale L, Jiang Y, Aycock J, Elias M, Chang D, Wiezorek J, Go WY. Axicabtagene Ciloleucel CAR T-Cell Therapy in Refractory Large B-Cell Lymphoma. N Engl J Med. 2017 Dec 28;377(26):2531-2544. doi: 10.1056/NEJMoa1707447. Epub 2017 Dec 10.
PubMed 29226797Schuster SJ, Bishop MR, Tam CS, Waller EK, Borchmann P, McGuirk JP, Jager U, Jaglowski S, Andreadis C, Westin JR, Fleury I, Bachanova V, Foley SR, Ho PJ, Mielke S, Magenau JM, Holte H, Pantano S, Pacaud LB, Awasthi R, Chu J, Anak O, Salles G, Maziarz RT; JULIET Investigators. Tisagenlecleucel in Adult Relapsed or Refractory Diffuse Large B-Cell Lymphoma. N Engl J Med. 2019 Jan 3;380(1):45-56. doi: 10.1056/NEJMoa1804980. Epub 2018 Dec 1.
PubMed 30501490Maude SL, Laetsch TW, Buechner J, Rives S, Boyer M, Bittencourt H, Bader P, Verneris MR, Stefanski HE, Myers GD, Qayed M, De Moerloose B, Hiramatsu H, Schlis K, Davis KL, Martin PL, Nemecek ER, Yanik GA, Peters C, Baruchel A, Boissel N, Mechinaud F, Balduzzi A, Krueger J, June CH, Levine BL, Wood P, Taran T, Leung M, Mueller KT, Zhang Y, Sen K, Lebwohl D, Pulsipher MA, Grupp SA. Tisagenlecleucel in Children and Young Adults with B-Cell Lymphoblastic Leukemia. N Engl J Med. 2018 Feb 1;378(5):439-448. doi: 10.1056/NEJMoa1709866.
PubMed 29385370Rodriguez-Lobato LG, Ganzetti M, Fernandez de Larrea C, Hudecek M, Einsele H, Danhof S. CAR T-Cells in Multiple Myeloma: State of the Art and Future Directions. Front Oncol. 2020 Jul 28;10:1243. doi: 10.3389/fonc.2020.01243. eCollection 2020.
PubMed 32850376Munshi NC, Anderson LD Jr, Shah N, Madduri D, Berdeja J, Lonial S, Raje N, Lin Y, Siegel D, Oriol A, Moreau P, Yakoub-Agha I, Delforge M, Cavo M, Einsele H, Goldschmidt H, Weisel K, Rambaldi A, Reece D, Petrocca F, Massaro M, Connarn JN, Kaiser S, Patel P, Huang L, Campbell TB, Hege K, San-Miguel J. Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma. N Engl J Med. 2021 Feb 25;384(8):705-716. doi: 10.1056/NEJMoa2024850.
PubMed 33626253Rabinowich H, Pricop L, Herberman RB, Whiteside TL. Expression and function of CD7 molecule on human natural killer cells. J Immunol. 1994 Jan 15;152(2):517-26.
PubMed 7506726
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Safety, Tolerability and Initial Efficacy of Anti-GPRC5D-CD19-CAR-T in Patients With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06298266
- Acronym / sponsor ID
- GD2H-XYK-001
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Keywords
- GPRC5D-CD19 CART, Multiple myeloma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Guangdong Second Provincial General HospitalUniversity, hospital or other
- Study start
- 29 Mar 2024 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and tolerability of anti-GPRC5D-CD19 CAR-T cells infusion in subjects with relapsed and refractory multiple myeloma
Detailed description
This study is a single-arm, single-center clinical study of IIT to evaluate the safety, tolerability, pharmacokinetic profile, and initial efficacy of GPRC5D-CD19 CAR T cells in subjects with MM. The safety of GPRC5D-CD19 CAR T was evaluated by observing adverse events after cell therapy. Evaluate the effectiveness of GPRC5D-CD19 CAR T treatment compared to the results of the subjects' own previous standard treatment regimens or base data. Blood and bone marrow were collected before and 24 months after the GPRC5D-CD19 CAR T infusion to detection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| infusion of GPRC5D-CD19 CAR T injection | Experimental | Biological: infusion of GPRC5D-CD19 CAR T injectionInfusion of GPRC5D-CD19 CAR T cells injection by dose of 1.0×10^6 /kg±20 % CAR-T ，3.0×10^6 /kg±20%、6.0×10^6 /kg±20%. Administration method: intravenous infusion. Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 1. The patient or their legal guardian understands and voluntarily signs the informed consent form and is expected to complete the follow-up examinations and treatments.
- 2. Age between 18-75 years, regardless of gender. 3. Diagnosed with multiple myeloma according to the IMWG diagnostic criteria, and GPRC5D expression in bone marrow is positive (>10%).
- 4. Has failed treatment with at least three different mechanisms of drugs (including chemotherapy, proteasome inhibitors, immune modulators, etc.), or has experienced disease progression or relapse within 6 months after the last treatment.
- 5. Measurable lesions are present based on any of the following criteria during screening: (1) Serum monoclonal immunoglobulin (M-protein) level ≥1.0 g/dL; (2) Urine M-protein level ≥200 mg/24 hours; (3) Diagnosed with light chain multiple myeloma with no measurable lesions in serum or urine: Serum free light chain ≥10 mg/dL and abnormal serum free light chain κ/γ ratio.
- 6. The patient has recovered from toxicities associated with previous treatment, i.e., CTCAE toxicity grade <2 (unless the abnormality is related to the tumor or stable, with no significant impact on safety or efficacy as determined by the investigator).
Key exclusion criteria (15 listed)
- 1. Diagnosed with or treated for invasive malignant tumors other than multiple myeloma.
- 2. Previously received anti-tumor treatments including targeted therapy, epigenetic therapy, experimental drug therapy, or invasive experimental medical devices within 14 days or at least 5 half-lives (whichever is shorter) before the collection and preparation of CAR-T cells. Also, received monoclonal antibody therapy for relapsed/refractory multiple myeloma within 21 days, received cytotoxic therapy within 14 days, received proteasome inhibitor therapy within 14 days, received immunomodulatory agent therapy within 7 days, or received radiation therapy within 14 days (except for bone marrow reserves with field coverage ≤5%).
- 3. Suspected involvement of multiple myeloma in the central nervous system or meninges confirmed by MRI or CT, or presence of other active central nervous system diseases.
- 4. Screening criteria include plasma cell leukemia (according to standard classification, plasma cells >2.0×109/L), Waldenstrom macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or secondary AL amyloidosis.
- 5. Positive for hepatitis B surface antigen (HBsAg) and positive for HBV-DNA; positive for hepatitis C virus (HCV) antibody; positive for human immunodeficiency virus (HIV) antibody; cytomegalovirus (CMV) DNA test result ≥500 copies/mL; positive for syphilis test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| infusion of GPRC5D-CD19 CAR T injectionInfusion of GPRC5D-CD19 CAR T cells injection by dose of 1.0×10^6 /kg±20 % CAR-T ，3.0×10^6 /kg±20%、6.0×10^6 /kg±20%. Administration method: intravenous infusion. Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion. | Biological | infusion of GPRC5D-CD19 CAR T injection |
Primary outcome
Objective Response Rate
Time frame: Day 0, Month 1.5, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 18, Month 24
Subjects were evaluated for efficacy according to the IMWG Efficacy Assessment Criteria (2016 revision).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Background: PubMed 34873460Chen D, You F, Xiang S, Wang Y, Li Y, Meng H, An G, Zhang T, Li Z, Jiang L, Wu H, Sheng B, Zhang B, Yang L. Chimeric antigen receptor T cells derived from CD7 nanobody exhibit robust antitumor potential against CD7-positive malignancies. Am J Cancer Res. 2021 Nov 15;11(11):5263-5281. eCollection 2021.
- Background: PubMed 30875739Benmebarek MR, Karches CH, Cadilha BL, Lesch S, Endres S, Kobold S. Killing Mechanisms of Chimeric Antigen Receptor (CAR) T Cells. Int J Mol Sci. 2019 Mar 14;20(6):1283. doi: 10.3390/ijms20061283.
- Background: PubMed 26705086Harris DT, Kranz DM. Adoptive T Cell Therapies: A Comparison of T Cell Receptors and Chimeric Antigen Receptors. Trends Pharmacol Sci. 2016 Mar;37(3):220-230. doi: 10.1016/j.tips.2015.11.004. Epub 2015 Dec 17.
- Background: PubMed 26169254Srivastava S, Riddell SR. Engineering CAR-T cells: Design concepts. Trends Immunol. 2015 Aug;36(8):494-502. doi: 10.1016/j.it.2015.06.004. Epub 2015 Jul 11.
- Background: PubMed 24329793Dotti G, Gottschalk S, Savoldo B, Brenner MK. Design and development of therapies using chimeric antigen receptor-expressing T cells. Immunol Rev. 2014 Jan;257(1):107-26. doi: 10.1111/imr.12131.
- Background: PubMed 29226797Neelapu SS, Locke FL, Bartlett NL, Lekakis LJ, Miklos DB, Jacobson CA, Braunschweig I, Oluwole OO, Siddiqi T, Lin Y, Timmerman JM, Stiff PJ, Friedberg JW, Flinn IW, Goy A, Hill BT, Smith MR, Deol A, Farooq U, McSweeney P, Munoz J, Avivi I, Castro JE, Westin JR, Chavez JC, Ghobadi A, Komanduri KV, Levy R, Jacobsen ED, Witzig TE, Reagan P, Bot A, Rossi J, Navale L, Jiang Y, Aycock J, Elias M, Chang D, Wiezorek J, Go WY. Axicabtagene Ciloleucel CAR T-Cell Therapy in Refractory Large B-Cell Lymphoma. N Engl J Med. 2017 Dec 28;377(26):2531-2544. doi: 10.1056/NEJMoa1707447. Epub 2017 Dec 10.
- Background: PubMed 30501490Schuster SJ, Bishop MR, Tam CS, Waller EK, Borchmann P, McGuirk JP, Jager U, Jaglowski S, Andreadis C, Westin JR, Fleury I, Bachanova V, Foley SR, Ho PJ, Mielke S, Magenau JM, Holte H, Pantano S, Pacaud LB, Awasthi R, Chu J, Anak O, Salles G, Maziarz RT; JULIET Investigators. Tisagenlecleucel in Adult Relapsed or Refractory Diffuse Large B-Cell Lymphoma. N Engl J Med. 2019 Jan 3;380(1):45-56. doi: 10.1056/NEJMoa1804980. Epub 2018 Dec 1.
- Background: PubMed 29385370Maude SL, Laetsch TW, Buechner J, Rives S, Boyer M, Bittencourt H, Bader P, Verneris MR, Stefanski HE, Myers GD, Qayed M, De Moerloose B, Hiramatsu H, Schlis K, Davis KL, Martin PL, Nemecek ER, Yanik GA, Peters C, Baruchel A, Boissel N, Mechinaud F, Balduzzi A, Krueger J, June CH, Levine BL, Wood P, Taran T, Leung M, Mueller KT, Zhang Y, Sen K, Lebwohl D, Pulsipher MA, Grupp SA. Tisagenlecleucel in Children and Young Adults with B-Cell Lymphoblastic Leukemia. N Engl J Med. 2018 Feb 1;378(5):439-448. doi: 10.1056/NEJMoa1709866.
- Background: PubMed 32850376Rodriguez-Lobato LG, Ganzetti M, Fernandez de Larrea C, Hudecek M, Einsele H, Danhof S. CAR T-Cells in Multiple Myeloma: State of the Art and Future Directions. Front Oncol. 2020 Jul 28;10:1243. doi: 10.3389/fonc.2020.01243. eCollection 2020.
- Background: PubMed 33626253Munshi NC, Anderson LD Jr, Shah N, Madduri D, Berdeja J, Lonial S, Raje N, Lin Y, Siegel D, Oriol A, Moreau P, Yakoub-Agha I, Delforge M, Cavo M, Einsele H, Goldschmidt H, Weisel K, Rambaldi A, Reece D, Petrocca F, Massaro M, Connarn JN, Kaiser S, Patel P, Huang L, Campbell TB, Hege K, San-Miguel J. Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma. N Engl J Med. 2021 Feb 25;384(8):705-716. doi: 10.1056/NEJMoa2024850.
- Background: PubMed 7506726Rabinowich H, Pricop L, Herberman RB, Whiteside TL. Expression and function of CD7 molecule on human natural killer cells. J Immunol. 1994 Jan 15;152(2):517-26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qing Zhang, Doctoral principal investigator
Guangdong Second Provincial General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing infusion of GPRC5D-CD19 CAR T injection in people with Relapsed or Refractory Multiple Myeloma, run by Guangdong Second Provincial General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qing Zhang (+86 20 8916 8162, zhqing@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Day 0, Month 1.5, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 18, Month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06298266, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.